Name of Policy: Management of Obstructive Sleep Apnea Syndrome

Transcription

1 Name of Policy: Management of Obstructive Sleep Apnea Syndrome Policy #: 065 Latest Review Date: December 2015 Category: Surgery/Medical/DME Policy Grade: D Background/Definitions: As a general rule, benefits are payable under Blue Cross and Blue Shield of Alabama health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage: 1. The technology must have final approval from the appropriate government regulatory bodies; 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes; 3. The technology must improve the net health outcome; 4. The technology must be as beneficial as any established alternatives; 5. The improvement must be attainable outside the investigational setting. Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are: 1. In accordance with generally accepted standards of medical practice; and 2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient s illness, injury or disease; and 3. Not primarily for the convenience of the patient, physician or other health care provider; and 4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient s illness, injury or disease. Page 1 of 42

2 Description of Procedure or Service: Obstructive sleep apnea (OSA) syndrome is characterized by repetitive episodes of upper airway obstruction due to the collapse of the upper airway during sleep. This causes a drop in blood oxygenation and a brief arousal, and can occur as frequently as every minute throughout the night. The most common signs and symptoms in adults are snoring, excessive daytime sleepiness, and hypertension. Excessive daytime sleepiness may be subjective, and is assessed by questionnaires such as the Epworth Sleepiness Scale (ESS), a short self-administered questionnaire that asks patients how likely they are to fall asleep in different scenarios such as watching TV, sitting quietly in a car, or sitting and talking to someone. Daytime sleepiness is uncommon in young children with OSA. Symptoms in children may include disturbed sleep and daytime neurobehavioral problems. In otherwise healthy children, OSA is usually associated with adenotonsillar hypertrophy and/or obesity. A hallmark sign of OSA is snoring. The snoring abruptly ceases during the apneic episodes and during the brief period of patient arousal and then resumes when the patient again falls asleep. Upper airway resistance syndrome (UARS) is a variant of OSA that is characterized by a partial collapse of the airway, resulting in increased resistance to airflow. The increased respiratory effort is associated with multiple sleep fragmentations, as measured by very short alpha electroencephalographic (EEG) arousals ( respiratory event-related arousals [RERAs]). The sleep fragmentation associated with repeated sleep disruption can lead to impairment of daytime activity. Adult patients with OSA-associated daytime somnolence are thought to be at higher risk for accidents involving motorized vehicles, i.e., cars, trucks, or heavy equipment, while OSA in children may result in neurocognitive impairment and behavioral problems. OSA can also affect the cardiovascular and pulmonary systems. For example, apnea leads to periods of hypoxia, alveolar hypoventilation, hypercapnia, and acidosis. This in turn can cause systemic hypertension, cardiac arrhythmias, and cor pulmonale. Systemic hypertension is common in patients with OSA. Severe OSA is associated with decreased survival, presumably related to severe hypoxemia, hypertension, or an increase in automobile accidents related to overwhelming sleepiness. It is estimated that about 7% of adults have moderate or severe OSA, and 20% have at least mild OSA and that the referral population of OSA patients represents a small proportion of patients who have clinically significant and treatable disease. Diagnosis The gold standard diagnostic test for sleep disorders is a polysomnogram performed in a sleep laboratory. A standard polysomnogram includes EEG, submental electromyogram (EMG) and electro-oculogram (to detect rapid eye movement [REM] sleep) for sleep staging. PSG also typically includes electrocardiography and monitoring of respiratory airflow, effort, snoring, oxygen desaturation, and sleep position. An attended study ensures that the electrodes and sensors are functioning adequately and do not become dislodged during the night. In addition, an attendant is able to identify severe OSA in the first part of the night and titrate CPAP in the second part of the night, commonly known as a "split-night" study. If successful, this strategy can eliminate the need for an additional PSG for CPAP titration. Auto-adjusting positive airway pressure (APAP) may also be used to determine the most effective pressure. Page 2 of 42

3 Typically, the evaluation of OSA includes sleep staging to assess arousals from sleep and determination of the frequency of apneas and hypopneas. In adults, apnea is defined as a drop in the peak signal excursion (airflow) by 90% or more of pre-event baseline for at least 10 seconds. Hypopnea in adults is scored when the peak signal excursions drop by at least 30% of pre-event baseline for at least 10 seconds in association with either at least 3% arterial oxygen desaturation or an arousal. The Apnea/Hypopnea Index (AHI) may also be referred to as the Respiratory Disturbance Index (RDI). The AHI is defined as the total number of events per hour of sleep. RDI may be defined as the number of apneas, hypopneas, and RERAs per hour of sleep. When sleep onset and offset are unknown, e.g., in home sleep studies, the RDI may be calculated based on the number of apneas and hypopneas per hour of recording time. A diagnosis of OSA is accepted when an adult patient has an AHI greater than 5 and symptoms of excessive daytime sleepiness or unexplained hypertension. An AHI equal to or greater than 15 is typically considered moderate OSA, while an AHI greater than 30 is considered severe OSA. Due to faster respiratory rates in children, pediatric scoring criteria define an apnea as two or more missed breaths, regardless of its duration in seconds. An apnea is scored when peak signal excursions (airflow) drop by at least 90% of pre-event baseline and the event meets duration and respiratory effort criteria for an obstructive, mixed, or central apnea. A hypopnea is scored in children when the peak signal excursions drop is at least 30% of pre-event baseline for at least the duration of two breaths in association with either a 3% or greater oxygen desaturation or an arousal. In pediatric patients, an AHI greater than 1.5 is considered abnormal, and an AHI of 10 or greater may be considered severe. Although there is poor correlation between AHI and OSA symptoms, an increase in mortality is associated with an AHI of greater than 15 in adults. Mortality has not been shown to be increased in adult patients with an AHI between five (considered normal) and 15. Apnea Risk Evaluation System (ARES ) In 2008, Ayappa et al reported a validation study of a small apnea monitor that is self-applied to the forehead. The device measures blood oxygen saturation and pulse rate, airflow, snoring levels, head movement and head position. The study enrolled 80 individuals with a high likelihood of OSA and 22 individuals with a low risk of OSA; results of simultaneous ARES recording and PSG were available for 92 individuals. When healthy subjects were excluded from the analysis, sensitivity and specificity (0.91, 0.92) were relatively high for an AHI of 15 or greater, but dropped considerably with an AHI between 5 and 15 (sensitivity 0.97, specificity 0.78). Five percent of the subjects couldn t tolerate the device and were not included in the analysis. Medical Management Non-surgical treatment for obstructive sleep apnea or upper airway resistance syndrome includes weight loss, continuous positive airway pressure (CPAP), Bi-Level Positive airway pressure (Bi- PAP), auto-adjusting CPAP (APAP), or orthodontic repositioning. Nasal or oral continuous positive airway pressure (CPAP) is continuous positive airway pressure applied through the nose or via oral appliance. The pressure delivered comes through a flow generator to a mask and supplies a pressure level sufficient to keep the upper airway patent. The pressure used is determined individually with a CPAP trial. APAP adjusts the level of pressure based on the level of resistance, and thus administers a lower mean level of positive pressure during the night. Bi- Page 3 of 42

4 level positive airway pressure (BiPAP) provides two levels of positive pressure via a mask that augments patient ventilation. BiPAP responds to changes in the individual s inhalation and exhalation patterns and is normally instituted after a trial of CPAP has proven ineffective. Another alternative for the treatment of snoring and obstructive sleep apnea is oral appliances. Oral appliances are used for many purposes, including occlusal disorders. Oral appliances offer an alternative for sleep apnea patients dissatisfied with other therapies or unwilling to accept more complex interventions. The appliances may be a mandibular advancing device or tongue retainer that keeps the tongue in an anterior position. Other technologies are available on CPAP as pressure relief technology by reducing the pressure of exhalation and returning to therapeutic pressure just before inhalation. One type is made by Respironics and known as C-Flex; Bi-flex for BiPAP and A-flex as an auto adjusting technology. Bi-level positive airway pressure-spontaneous timed (BiPAP S/T) is not appropriate for obstructive apnea. It is designed to assist ventilation noninvasively. It is sometimes used for patients with neuromuscular respiratory insufficiency or restrictive lung disease from thoracic wall deformity and chronic respiratory failure due to chronic obstructive pulmonary disease (COPD). Other methods of assist ventilation that may be used invasively are not appropriate for obstructive sleep apnea. Additional information regarding BiPAP S/T is available on Blue Cross and Blue Shield of Alabama s medical policy #203, Respiratory Assist Device, Bi-level Pressure Capability, with Backup Rate Feature (BiPAP S/T). Auto-titrating continuous positive airway pressure (auto-cpap or APAP) utilizes a device that continually adjusts the level of pressure, as needed, to maintain airway patency. It has been investigated, both as a means to establish the required level of therapeutic "fixed" CPAP for long-term use, (as an alternative to sleep laboratory, technician- titrated CPAP), and as a longterm therapeutic alternative to fixed CPAP in adults. Surgical Management Uvulopalatopharyngoplasty Uvulopalatopharyngoplasty (UPPP) involves surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula. The amount of tissue removed is individualized for each patient as determined by the potential space and width of the tonsillar pillar mucosa between the two palatal arches. The UPPP enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Thus, patients who fail UPPP may be candidates for additional procedures, depending on the site of obstruction. Additional procedures include hyoid suspensions, maxillary and mandibular osteotomies, or modification of the tongue. Fiberoptic endoscopy and/or cephalometric measurements have been used as methods to identify hypopharyngeal obstruction in these patients. The first-line treatment in children is usually adenotonsillectomy. Minimally invasive surgical approaches being evaluated for OSA in adults include the following. Laser-assisted Uvulopalatoplasty The laser-assisted uvulopalatoplasty (LAUP) is an outpatient alternative that has been promoted as a treatment of snoring with or without associated obstructive sleep apnea. In this procedure superficial palatal tissues are sequentially reshaped using a CO2 laser and does not remove or Page 4 of 42

5 alter tonsils or lateral pharyngeal wall tissues. The patient may undergo from three to seven sessions at three to four week intervals. LAUP cannot be considered an equivalent procedure to the standard UPPP, with the laser simply representing a surgical tool that the physician may opt to use. LAUP is considered a unique procedure, which raises its own issues of safety and, in particular, effectiveness. Radiofrequency Ablation of Palatal Tissues and the Tongue Radiofrequency ablation of the soft palate is similar in concept to LAUP, although a different energy source is used. Radiofrequency is used to produce thermal lesions within the tissues rather than using a laser to ablate the tissue surface, which may be painful. For this reason, RFA appears to be growing in popularity as an alternative to LAUP. In some situations, radiofrequency of the soft palate and base of tongue are performed together as a multilevel procedure. Tongue-base Suspension In this procedure, the base of the tongue is suspended with a suture that is passed through the tongue and then fixated with a screw to the inner side of the mandible, below the tooth roots. The aim of the suspension is to make it less likely for the base of the tongue to prolapse during sleep. Palatal Stiffening Palatal stiffening procedures include insertion of palatal implants, injection of a sclerosing agent (snoreplasty), or a cautery-assisted palatal stiffening operation (CAPSO). The CAPSO procedure uses cautery to induce a midline palatal scar designed to stiffen the soft palate to eliminate excessive snoring. The palatal implant device is a cylindrical-shaped segment of braided polyester filaments that is permanently implanted submucosally in the soft palate. Hypoglossal Nerve Stimulation Hypoglossal Nerve Stimulation results in contraction of the genioglossus muscle, the largest upper airway dilatory muscle. This causes tongue protrusion and stiffening of the anterior pharyngeal wall, potentially leading to a decrease in apneic events. Hypoglossal nerve stimulation systems include an implantable neurostimulator, stimulating leads, and electrodes. Intermittent simulation systems also include respiratory sensing leads. Uvulectomy Uvulectomy is the excision of the uvula and is sometimes performed for snoring. Midline Glossectomy An enlarged tongue may also be a part of the obstructive airway. A midline glossectomy (MLG) removes redundant tissue at the base of the tongue by making a V-type incision in the tongue to decrease excess tissue. Genioglossal Advancement Genioglossal advancement has the advantage of not altering the jaw position or occlusion. There are several techniques for this procedure. Osteotomies that are performed are angled to include the geniotubercle. Hyoid suspension and myotomy includes advancement of the hyoid bone anteriorly to the mandible or alternatively advanced onto the laryngeal cartilage. Advancement Page 5 of 42

6 of the hyoid bone through its attachments draws the epiglottis, vallecula, and tongue base forward. Maxillomandibular advancement includes a standard Le Fort I osteotomy in combination with bilateral sagittal split ramus osteotomies for the simultaneous advancement of the maxilla and mandible. In many cases, advancement geniotomy, with or without hyoid myotomy and suspension, is also performed. Atrial Overdrive Pacing The use of atrial overdrive pacing (AOD) is also being evaluated in the treatment of obstructive sleep apnea. This approach is being tried because of the bradycardia that generally occurs during episodes of apnea. Oral Appliances Oral appliances can be broadly categorized as mandibular advancing/positioning devices or tongue-retaining devices. Oral appliances can either be off the shelf or custom made for the patient by a dental laboratory or similar provider. Policy: Effective for dates of service on or after June 17, 2014: Medical Management of OSA CPAP for Obstructive Sleep Apnea (OSA) Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) in adults meets Blue Cross and Blue Shield of Alabama s coverage criteria for patients who meet either of the following criteria on polysomnography: 1. Apnea Hypopnea Index (AHI) greater than or equal to 15 events per hour; OR 2. AHI greater than or equal to five, and less than 15 events per hour with documentation demonstrating any of the following symptoms: Excessive daytime sleepiness, as documented by either a cumulative or total score of ten or greater on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or Impaired cognition or mood disorders; or Hypertension; or Ischemic heart disease, congestive heart failure or history of stroke; or Cardiac arrhythmias; or Pulmonary hypertension; or Insomnia. Note: Nocturnal polysomnogram testing to determine coverage should be performed in an approved facility. Page 6 of 42

7 CPAP for CHILDREN CPAP for the treatment of obstructive sleep apnea (OSA) in children (17 years of age or younger) meets Blue Cross and Blue Shield of Alabama s coverage criteria when the following criteria are met: There is a documented diagnosis of obstructive sleep apnea (OSA) and polysomnography demonstrates an apnea index (AI) or apnea-hypopnea index (AHI) equal to or greater than one (1); AND Adenotonsillectomy has been unsuccessful in relieving OSA; OR Adenotonsillar tissue is minimal; OR Adenotonsillectomy is inappropriate based on OSA being attributable to another underlying cause (e.g., septum deviations, facial abnormalities (craniofacial syndromes), obesity or when adenotonsillectomy is contraindicated. Compliance Documentation Compliance documentation should be maintained in the supplier s record. This documentation should include that the physician certifies the patient is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper usage. ( 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis i.e. Accidents, change in physical status, surgery, etc.) Related Supply Coverage The following supplies meet Blue Cross and Blue Code Maximum Shield of Alabama s criteria for coverage based on the following frequency when the above equipment is determined to be covered: Item Full face mask, each A in 180 days Chinstrap A in 180 days Combination Oral/Nasal Mask, each A in 180 days Face Mask Interface, replacement for full face mask A in 180 days Filter, disposable A in 90 days Headgear/Softcap A in 180 days Nasal interface (mask or cannula type) A in 180 days Nose Pillows (Pair) A in 180 days Oral Interface Used With Positive Airway Pressure Device, Each A in 180 days Page 7 of 42

8 Replacement Cushion for nasal mask interface A in 180 days Replacement Nasal Pillows for Combination Oral/Nasal Mask A in 180 days Replacement Oral Cushion for Combination Oral/Nasal Mask A in 180 days Filter, non-disposable A in 180 days Tubing/Hose A per 120 days (for dates of service Heated tubing A /01/14 and after) 1 per 365 days (for dates of service prior to 05/01/14) Non-heated humidifier E every 3 years Heated humidifier E every 3 years CPAP machine E every 3 years Supplies are not covered separately in Alabama when billed during the 10 month rental period or within the first 10 months after the purchase Supplier should receive a request for additional supplies and should not automatically deliver supplies/accessories on a predetermined routine basis. Replacement Devices Previously covered devices meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage to be replaced when the following criteria are met: (a repeat sleep study is not required) The equipment has suffered irreparable damage (cost more to repair than to replace) and has been in the home for three years or longer; OR The patient s condition has changed and a different piece of equipment is determined to be medically necessary. Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model. (Compliance documentation is not required for replacement equipment.) Replacement devices should be filed with modifier RA to indicate they are not the initial device but a replacement piece of equipment. Note: The AHI (Apnea Hypopnea Index) is equal to the average number of episodes of apnea and hypopnea per hour of sleep and must be based on a minimum of two hours (unless an emergency protocol was activated) of sleep recorded by polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected). The RDI (Respiratory Page 8 of 42

9 Disturbance Index) may be defined as the number of apneas, hypopneas, and Respiratory eventrelated arousals (RERAs) per hour of sleep. Respiratory event-related arousals (RERAs) are scored if there is a sequence of breaths lasting at least 10 seconds characterized by increasing respiratory effort or flattening of the nasal pressure waveform leading to an arousal from sleep when the sequence of breaths does not meet criteria for an apnea or hypopnea. For purposes of this policy, apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined using either the AASM recommended or alternative definitions. Leg movement, snoring, and other sleep disturbances that may be included by some polysomnographic facilities are not considered to meet the AHI and/or RDI definition in this policy. Although AHI and RDI have been used interchangeably, some facilities use the term RDI to describe a calculation that includes these other sleep disturbances. Requests for the following pieces of DME will be considered not medically necessary if based upon an index that does not score apneas, hypopneas and RERAs separately from other sleep disturbance events. Only persons with an AHI and/or RDI, as defined in this policy that meets medical necessity criteria may qualify for coverage. Oral Devices for Obstructive Sleep Apnea (OSA) Oral Pressure Therapy (OPT) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational (an example of this therapy is Winx, Sleep Therapy System by ApniCure). Oral appliances for the treatment of obstructive sleep apnea meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when all of the following criteria are met: Nocturnal polysomnogram has been performed in an approved facility and a diagnosis of obstructive sleep apnea has been made; AND Devices are used in patients who prefer oral appliances to CPAP, who do not respond to CPAP, OR have failed CPAP treatment; and ordered by the physician treating the patient for the diagnosed obstructive sleep apnea: AND The device must be fitted by qualified dental personnel (Over the counter devices or prefabricated, even if fitted by dental personnel are not covered). Oral appliances for snoring do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. EPAP Nasal Expiratory Airway Pressure (EPAP) also known as PROVENT does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered investigational. Please refer to Benefit Applications section of this policy for further information on oral appliance coverage. Surgical Management of OSA: Uvulopalatopharyngoplasty (UPPP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Page 9 of 42

10 airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Laser-assisted uvulopalatoplasty (LAUP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Laser-assisted uvulopalatoplasty (LAUP) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Genioglossal advancement, hyoid suspension and myotomy and other mandibularmaxillary advancement meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of obstructive sleep apnea when the following criteria are met: AHI > 20 or oxygen desaturations less than 90% as determined by a nocturnal polysomnogram has been performed in an approved facility Cephalometric abnormalities (Clinically Significant) Hypopharyngeal obstruction CPAP/BIPAP trial over a period of time (unless RDI less than 5 cannot be achieved) or patient has immediate intolerance (true claustrophobic reaction) Otolaryngologist evaluation with appropriate interventions Page 10 of 42

11 If UPPP performed prior to orthognathic surgery, will need to repeat sleep study demonstrating obstructive sleep apnea Radiofrequency ablation of palatal tissues or radiofrequency volumetric tissue reduction (Somnoplasty) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational for simple snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome. Uvulectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Midline glossectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of upper airway obstruction syndrome and obstructive sleep apnea syndrome and is considered investigational. Palatal stiffening procedures, including but not limited to, cautery assisted palatal stiffening operation, and the implantation of palatal implants, do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered non-covered in the treatment of snoring alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA. Atrial pacing does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Repose tongue suspension system does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Implantable hypoglossal nerve stimulators do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational for all indications, including but not limited to the treatment of OSA. Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered non-covered. Page 11 of 42

12 Effective for dates of service on or after May 1, 2014 through June 16, 2014: Medical Management of OSA CPAP for Obstructive Sleep Apnea (OSA) Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) in adults meets Blue Cross and Blue Shield of Alabama s coverage criteria for patients who meet either of the following criteria on polysomnography: 1. Apnea Hypopnea Index (AHI) greater than or equal to 15 events per hour; OR 2. AHI greater than or equal to five, and less than 15 events per hour with documentation demonstrating any of the following symptoms: a. Excessive daytime sleepiness, as documented by either a cumulative or total score of ten or greater on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or b. Impaired cognition or mood disorders; or c. Hypertension; or d. Ischemic heart disease, congestive heart failure or history of stroke; or e. Cardiac arrhythmias; or f. Pulmonary hypertension; or g. Insomnia. Note: Nocturnal polysomnogram testing to determine coverage should be performed in an approved facility. CPAP for CHILDREN CPAP for the treatment of obstructive sleep apnea (OSA) in children (17 years of age or younger) meets Blue Cross and Blue Shield of Alabama s coverage criteria when the following criteria are met: There is a documented diagnosis of obstructive sleep apnea (OSA) and polysomnography demonstrates an apnea index (AI) or apnea-hypopnea index (AHI) equal to or greater than one (1); AND Adenotonsillectomy has been unsuccessful in relieving OSA; OR Adenotonsillar tissue is minimal; OR Adenotonsillectomy is inappropriate based on OSA being attributable to another underlying cause (e.g., septum deviations, facial abnormalities (craniofacial syndromes), obesity or when adenotonsillectomy is contraindicated. Compliance Documentation Compliance documentation should be maintained in the supplier s record. This documentation should include that the physician certifies the patient is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper usage. ( 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis i.e.; accidents, change in physical status, surgery, etc.). Page 12 of 42

13 Related Supply Coverage The following supplies meet Blue Cross and Blue Shield of Alabama s criteria for coverage based on the following frequency when the above equipment is determined to be covered: Item Code Maximum Full face mask, each A in 180 days Chinstrap A in 180 days Combination Oral/Nasal Mask, each A in 180 days Face Mask Interface, replacement for full face A in 180 days mask Filter, disposable A in 90 days Headgear/Softcap A in 180 days Nasal interface (mask or cannula type) A in 180 days Nose Pillows (Pair) A in 180 days Oral Interface Used With Positive Airway Pressure A in 180 days Device, Each Replacement Cushion for nasal mask interface A in 180 days Replacement Nasal Pillows for Combination A in 180 days Oral/Nasal Mask Replacement Oral Cushion for Combination A in 180 days Oral/Nasal Mask Filter, non-disposable A in 180 days Tubing/Hose A per 120 days Heated tubing A4604 (for dates of service 05/01/14 and after) 1 per 365 days (for dates of service prior to 05/01/14) Non-heated humidifier E every 3 years Heated humidifier E every 3 years CPAP machine E every 3 years Supplies are not covered separately in Alabama when billed during the 10 month rental period or within the first 10 months after the purchase. Supplier should receive a request for additional supplies and should not automatically deliver supplies/accessories on a predetermined routine basis. Page 13 of 42

14 Replacement Devices Previously covered devices meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage to be replaced when the following criteria are met: (a repeat sleep study is not required) The equipment has suffered irreparable damage (cost more to repair than to replace) and has been in the home for 3 years or longer; OR The patient s condition has changed and a different piece of equipment is determined to be medically necessary. Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model. (Compliance documentation is not required for replacement equipment.) Replacement devices should be filed with modifier RA to indicate they are not the initial device but a replacement piece of equipment. Note: The AHI (Apnea Hypopnea Index) is equal to the average number of episodes of apnea and hypopnea per hour of sleep and must be based on a minimum of two hours (unless an emergency protocol was activated) of sleep recorded by polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected). The RDI (Respiratory Disturbance Index) is equal to the episodes of apnea and hypopnea per hour of measurement. For purposes of this policy, apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined using either the AASM recommended or alternative definitions. * Leg movement, snoring, respiratory effort related arousals (RERAs), and other sleep disturbances that may be included by some polysomnographic facilities are not considered to meet the AHI and/or RDI definition in this policy. Although AHI and RDI have been used interchangeably, some facilities use the term RDI to describe a calculation that includes these other sleep disturbances. Requests for the following pieces of DME will be considered not medically necessary if based upon an index that does not score apneas and hypopneas separately from other sleep disturbance events (RERAs). Only persons with an AHI and/or RDI, as defined in this policy that meets medical necessity criteria may qualify for coverage. Oral Devices for Obstructive Sleep Apnea (OSA) Oral Pressure Therapy (OPT) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational (an example of this therapy is Winx, Sleep Therapy System by ApniCure). Oral appliances for the treatment of obstructive sleep apnea meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when all of the following criteria are met: Nocturnal polysomnogram has been performed in an approved facility and a diagnosis of obstructive sleep apnea has been made; AND Devices are used in patients who prefer oral appliances to CPAP, who do not respond to CPAP, OR have failed CPAP treatment; and ordered by the physician treating the patient for the diagnosed obstructive sleep apnea: AND Page 14 of 42

15 The device must be fitted by qualified dental personnel (Over the counter devices or prefabricated, even if fitted by dental personnel are not covered). Oral appliances for snoring do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. EPAP Nasal Expiratory Airway Pressure (EPAP) also known as PROVENT does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered investigational. Please refer to Benefit Applications section of this policy for further information on oral appliance coverage. Surgical Management of OSA: Uvulopalatopharyngoplasty (UPPP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Laser-assisted uvulopalatoplasty (LAUP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Page 15 of 42

16 Laser-assisted uvulopalatoplasty (LAUP) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Genioglossal advancement, hyoid suspension and myotomy and other mandibularmaxillary advancement meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of obstructive sleep apnea when the following criteria are met: AHI > 20 or oxygen desaturations less than 90% as determined by a nocturnal polysomnogram has been performed in an approved facility; Cephalometric abnormalities; (Clinically Significant) Hypopharyngeal obstruction; CPAP/BIPAP trial over a period of time (unless RDI less than 5 cannot be achieved) or patient has immediate intolerance (true claustrophobic reaction); Otolaryngologist evaluation with appropriate interventions; If UPPP performed prior to orthognathic surgery, will need to repeat sleep study demonstrating obstructive sleep apnea. Radiofrequency ablation of palatal tissues or radiofrequency volumetric tissue reduction (Somnoplasty) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational for simple snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome. Uvulectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Midline glossectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of upper airway obstruction syndrome and obstructive sleep apnea syndrome and is considered investigational. Palatal stiffening procedures, including but not limited to, cautery assisted palatal stiffening operation, and the implantation of palatal implants, do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered non-covered in the treatment of snoring alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA. Atrial pacing does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Repose tongue suspension system does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency Page 16 of 42

17 volumetric tissue reduction of the palate, or palatal stiffening procedures, does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered non-covered. Effective for dates of service on or after June 25, 2012 and prior to April 30, 2014: Medical Management of OSA CPAP for Obstructive Sleep Apnea (OSA) Continuous positive airway pressure (CPAP) for the treatment of obstructive sleep apnea (OSA) in adults meets Blue Cross and Blue Shield of Alabama s coverage criteria for patients who meet either of the following criteria on polysomnography: 1. Apnea Hypopnea Index (AHI) greater than or equal to 15 events per hour; OR 2. AHI greater than or equal to five, and less than 15 events per hour with documentation demonstrating any of the following symptoms: Excessive daytime sleepiness, as documented by either a cumulative or total score of ten or greater on the Epworth Sleepiness scale or inappropriate daytime napping, (e.g., during driving, conversation or eating) or sleepiness that interferes with daily activities; or Impaired cognition or mood disorders; or Hypertension; or Ischemic heart disease, congestive heart failure or history of stroke; or Cardiac arrhythmias; or Pulmonary hypertension; or Insomnia. Note: Nocturnal polysomnogram testing to determine coverage should be performed in an approved facility. Note: The AHI is equal to the average number of episodes of apnea and hypopnea per hour and must be based on a minimum of two hours (unless an emergency protocol was activated) of sleep recorded by polysomnography using actual recorded hours of sleep, (i.e., the AHI may not be extrapolated or projected). CPAP for CHILDREN CPAP for the treatment of obstructive sleep apnea (OSA) in children (17 years of age or younger) meets Blue Cross and Blue Shield of Alabama s coverage criteria when the following criteria are met: There is a documented diagnosis of obstructive sleep apnea (OSA) and polysomnography demonstrates an apnea index (AI) or apnea-hypopnea index (AHI) equal to or greater than one (1); AND Adenotonsillectomy has been unsuccessful in relieving OSA; OR Adenotonsillar tissue is minimal; OR Page 17 of 42

18 Adenotonsillectomy is inappropriate based on OSA being attributable to another underlying cause (e.g., septum deviations, facial abnormalities (craniofacial syndromes), obesity or when adenotonsillectomy is contraindicated. Compliance Documentation Compliance documentation should be maintained in the supplier s record. This documentation should include that the physician certifies the patient is compliant with the treatment and the sleep disorder has improved based on the treatment OR a recorded compliance document indicating proper usage. ( 4 hours per night on 70% of the nights during a 30 consecutive day period during the initial 90 days of usage) (Compliance documentation that extended beyond the 90 days will be reviewed on an individual basis i.e. Accidents, change in physical status, surgery, etc.) Related Supply Coverage The following supplies meet Blue Cross and Blue Shield of Alabama s criteria for coverage based on the following frequency when the above equipment is determined to be covered: Item Code Maximum Full face mask, each A in 180 days Chinstrap A in 180 days Combination Oral/Nasal Mask, each A in 180 days Face Mask Interface, replacement for full face A in 180 days mask Filter, disposable A in 90 days Headgear/Softcap A in 180 days Nasal interface (mask or cannula type) A in 180 days Nose Pillows (Pair) A in 180 days Oral Interface Used With Positive Airway Pressure A in 180 days Device, Each Replacement Cushion for nasal mask interface A in 180 days Replacement Nasal Pillows for Combination A in 180 days Oral/Nasal Mask Replacement Oral Cushion for Combination A in 180 days Oral/Nasal Mask Filter, non-disposable A in 180 days Tubing/Hose A in 365 days Heated tubing A in 365 days Non-heated humidifier E every 3 years Heated humidifier E every 3 years CPAP machine E every 3 years Page 18 of 42

19 Supplies are not covered separately in Alabama when billed during the 10 month rental period or within the first 10 months after the purchase. Supplier should receive a request for additional supplies and should not automatically deliver supplies/accessories on a predetermined routine basis. Replacement Devices Previously covered devices meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage to be replaced when the following criteria are met: (a repeat sleep study is not required) The equipment has suffered irreparable damage (cost more to repair than to replace) and has been in the home for three years or longer; OR The patient s condition has changed and a different piece of equipment is determined to be medically necessary. Replacement devices will not be covered for replacing functioning equipment with a newer more advanced model. (Compliance documentation is not required for replacement equipment.) Replacement devices should be filed with modifier RA to indicate they are not the initial device but a replacement piece of equipment. NOTE: The AHI (Apnea Hypopnea Index) is equal to the average number of episodes of apnea and hypopnea per hour of sleep. The RDI (Respiratory Disturbance Index) is equal to the episodes of apnea and hypopnea per hour of measurement. For purposes of this policy, apnea is defined as a cessation of airflow for at least 10 seconds. Hypopnea is defined using either the AASM recommended or alternative definitions.* Leg movement, snoring, respiratory effort related arousals (RERAs), and other sleep disturbances that may be included by some polysomnographic facilities are not considered to meet the AHI and/or RDI definition in this policy. Although AHI and RDI have been used interchangeably, some facilities use the term RDI to describe a calculation that includes these other sleep disturbances. Requests for the following pieces of DME will be considered not medically necessary if based upon an index that does not score apneas and hypopneas separately from other sleep disturbance events (RERAs). Only persons with an AHI and/or RDI, as defined in this policy that meets medical necessity criteria may qualify for coverage. Oral Devices for Obstructive Sleep Apnea (OSA) Oral Pressure Therapy (OPT) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational (an example of this therapy is Winx, Sleep Therapy System by ApniCure). Oral appliances for the treatment of obstructive sleep apnea meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage when all of the following criteria are met: Nocturnal polysomnogram has been performed in an approved facility and a diagnosis of obstructive sleep apnea has been made; AND Page 19 of 42

20 Devices are used in patients who prefer oral appliances to CPAP, who do not respond to CPAP, OR have failed CPAP treatment; and ordered by the physician treating the patient for the diagnosed obstructive sleep apnea: AND The device must be fitted by qualified dental personnel (Over the counter devices or prefabricated, even if fitted by dental personnel are not covered) Oral appliances for snoring do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered investigational. EPAP Nasal Expiratory Airway Pressure (EPAP) also known as PROVENT does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered investigational. Please refer to Benefit Applications section of this policy for further information on oral appliance coverage. Surgical Management of OSA: Uvulopalatopharyngoplasty (UPPP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Laser-assisted uvulopalatoplasty (LAUP) meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage when treatment options have been discussed with the patient including but not limited to: weight loss, Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), medications and alternative surgical procedures. The following conditions and criteria must be met: Diagnosis of obstructive sleep apnea is made with a polysomnogram study performed at an approved sleep study center (not an at home study) and there is documentation of an Apnea-Hypopnea Index (AHI) greater than or equal to 15. Physical examination that includes but is not limited to: anterior rhinoscopy; endoscopic examination of nose, pharynx, and hypopharynx; evaluation of the nasal septum and Page 20 of 42

21 nasal turbinates; evaluation of nasal polyps or other masses; Muller s maneuver and evaluation of the tonsillar/adenoidal tissue; anatomical evaluation for cephalometric disproportion. Laser-assisted uvulopalatoplasty (LAUP) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Genioglossal advancement, hyoid suspension and myotomy and other mandibularmaxillary advancement meets Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of obstructive sleep apnea when the following criteria are met: AHI > 20 or oxygen desaturations less than 90% as determined by a nocturnal polysomnogram has been performed in an approved facility; Cephalometric abnormalities; (Clinically Significant) Hypopharyngeal obstruction; CPAP/BIPAP trial over a period of time (unless RDI less than 5 cannot be achieved) or patient has immediate intolerance (true claustrophobic reaction); Otolaryngologist evaluation with appropriate interventions; If UPPP performed prior to orthognathic surgery, will need to repeat sleep study demonstrating obstructive sleep apnea. Radiofrequency ablation of palatal tissues or radiofrequency volumetric tissue reduction (Somnoplasty) does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational for simple snoring, upper airway resistance syndrome and obstructive sleep apnea syndrome. Uvulectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational when used for the treatment of snoring. Midline glossectomy does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage for the treatment of upper airway obstruction syndrome and obstructive sleep apnea syndrome and is considered investigational. Palatal stiffening procedures, including but not limited to, cautery assisted palatal stiffening operation, and the implantation of palatal implants, do not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and are considered non-covered in the treatment of snoring alone, and are considered investigational as a treatment for upper airway resistance syndrome or OSA. Atrial pacing does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Repose tongue suspension system does not meet Blue Cross and Blue Shield of Alabama s medical criteria for coverage and is considered investigational. Page 21 of 42

22 Simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition; therefore, any surgical intervention, such as LAUP, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, does not meet Blue Cross and Blue Shield of Alabama s coverage criteria and is considered non-covered. Blue Cross and Blue Shield of Alabama does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. Blue Cross and Blue Shield of Alabama administers benefits based on the member s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination. Key Points: The most recent update and literature review was performed through October 12, In 2011, the Agency for Healthcare Research and Quality (AHRQ) conducted a comparative effectiveness review (CER) on the diagnosis and treatment of OSA in adults. The CER found strong evidence that an AHI greater than 30 events/hour is an independent predictor of all-cause mortality, with low or insufficient evidence for an association between AHI and other clinical outcomes. The CER found moderate evidence that Type 3 and Type 4 monitors may have the ability to accurately predict AHI suggestive of OSA and that Type 3 monitors perform better than Type 4 monitors at AHI cutoffs of 5, 10, and 15 events per hour. Despite no or weak evidence for an effect of CPAP on clinical outcomes, given the large magnitude of effect on the intermediate outcomes of AHI, Epworth Sleepiness Scale (ESS), and arousal index, the strength of evidence that CPAP is an effective treatment to alleviate sleep apnea signs and symptoms was rated moderate. The strength of the evidence that mandibular advancement devices improve sleep apnea signs and symptoms was rated moderate, and there was moderate evidence that CPAP is superior to mandibular advancement devices in improving sleep study measures. An improvement in postoperative outcomes with CPAP was suggested in a 2014 matched comparison between patients with OSA who had been diagnosed prior to surgery (2,640 surgeries), those who had not been diagnosed until up to five years after surgery (1,571 surgeries), and 16,277 surgeries from patients without a diagnosis of OSA out of 21 years of available data. In multivariate analysis, the risk of respiratory complications was increased for both diagnosed and undiagnosed OSA patients compared to controls (odds ratio [OR] 2.08, p < 0.001). Diagnosed OSA was not associated with a significant risk reduction in respiratory complications. However, the risk of cardiovascular complications, primarily cardiac arrest and shock, was increased in OSA patients who had not been diagnosed until after surgery (relative risk 2.20, 95% CI , p=0.02), but not in those who had been diagnosed prior to surgery (relative risk 0.75, 95% CI , p=0.29), and the difference between groups was significant at p= There was a significant trend of increased risk with increasing OSA severity. Limitations of the study include the inability to determine whether CPAP was used Page 22 of 42

23 peri-operatively, and since BMI could not be determined, potential confounding from the close association between obesity and OSA. Non-surgical Treatment Non-surgical treatment for obstructive sleep apnea or upper airway resistance syndrome includes weight loss, continuous positive airway pressure (CPAP), Bi-Level Positive airway pressure (Bi- PAP), auto-adjusting CPAP (APAP), or orthodontic repositioning. Nasal or oral continuous positive airway pressure (CPAP) is continuous positive airway pressure applied through the nose or via oral appliance. The pressure delivered comes through a flow generator to a mask and supplies a pressure level sufficient to keep the upper airway patent. The pressure used is determined individually with a CPAP trial. APAP adjusts the level of pressure based on the level of resistance, and thus administers a lower mean level of positive pressure during the night. Bilevel positive airway pressure (BiPAP) provides two levels of positive pressure via a mask that augments patient ventilation. BiPAP responds to changes in the individual s inhalation and exhalation patterns and is normally instituted after a trial of CPAP has proven ineffective. Oral Appliance Therapy Another alternative for the treatment of snoring and obstructive sleep apnea is oral appliances. Oral appliances are used for many purposes, including occlusal disorders. Oral appliances offer an alternative for sleep apnea patients dissatisfied with other therapies or unwilling to accept more complex interventions. The appliances may be a mandibular advancing device or tongue retainer that keeps the tongue in an anterior position. Other technologies are available on CPAP as pressure relief technology by reducing the pressure of exhalation and returning to therapeutic pressure just before inhalation. One type is made by Respironics and known as C-Flex; Bi-flex for BiPAP and A-flex as an auto adjusting technology. A systematic review of the evidence on the treatment of OSA with oral appliance therapy was performed for a 2015 update of clinical practice guidelines by the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine. Meta-analysis showed that oral appliances reduce AHI, arousal index, and oxygen desaturation index, and increase oxygen saturation. However, oral appliances had no significant effect on sleep architecture and sleep efficiency. Meta-analysis found CPAP to be more effective than oral appliances in reducing the AHI, arousal index, and oxygen desaturation index and improving oxygen desaturation, supporting the use of CPAP as a first line therapy for treating OSA. One of the studies included in the systematic review was a 2013 randomized crossover trial by Phillips et al, who found similar health outcomes after one month of CPAP or oral appliance therapy (OAT) in 126 patients (82% with moderate to severe OSA, AHI 15). CPAP was more effective than mandibular advancement therapy in reducing AHI (CPAP AHI=4.5, OAT AHI=11.1), but patient-reported compliance was higher with OAT (6.5 vs 5.2 hours/night). Neither treatment improved the primary outcome of 24-hour ambulatory blood pressure, except in a subgroup of patients who were initially hypertensive. The two treatments resulted in similar improvements in sleepiness (improvement, ), FOSQ (improvement, 1.0), some measures on driving simulator performance, and disease-specific quality of life. OAT was superior to CPAP in four domains on the SF-36. Page 23 of 42

24 Nasal EPAP One randomized controlled trial and several prospective case series have been published with the PROVENT device. In 2011, Berry et al reported an industry-sponsored multicenter double-blind randomized shamcontrolled trial of nasal EPAP. Two hundred fifty patients with OSA and an AHI of 10 or more per hour were randomized to nasal EPAP (n=127) or a sham device (n=123) for three months. PSG was performed on two nights (device-on, device off, in a random order) at week 1 (92% follow-up) and after three months of treatment (78% follow-up). EPAP reduced the AHI from a median of 13.8 to 5.0 (-52.7%) at week one and from 14.4 to 5.6 (-42.7%) at three months. This was a significantly greater reduction in AHI than the sham group (-7.3% at week 1, -10.1% at three months). Over three months, the decrease in ESS was statistically greater in the EPAP group (from 9.9 to 7.2) than in the sham group (from 9.6 to 8.3), although the clinical significance of a one point difference in the ESS is unclear. Treatment success and oxygenation data were presented only for the 58% of per-protocol patients who had an AHI of five or more per hour on the device-off PSG night. The oxygenation results (oxygenation desaturation index and % of total sleep time with SpO2 <90%) showed small but statistically significant decreases at one week and three months. Treatment success, defined as a 50% or greater reduction in the AHI or an AHI reduced to less than 10 (if device-off AHI was 10 or more), was greater in the EPAP group at one week (62% vs 27.2%) and three months (50.7% vs 22.4%). Device-related adverse events were reported by 45% of patients in the EPAP group and 34% of patients in the sham group, with 7% of patients in the EPAP group discontinuing the study due to adverse events. Overall, the validity of these results is limited by the high dropout rate, and the clinical significance of the results is uncertain. An open-label extension of the 2011 randomized study by Berry et al evaluated 12-month safety and durability of the treatment response in patients who had an initial favorable response to EPAP. Included were 41 patients (32% of 127) in the EPAP arm of the study who used the device for an average of at least four hours per night on at least five nights per week during months one and two and had at least a 50% reduction in AHI, or reduction to less than 10 events per hour, compared to the device-off PSG. Of the 51 patients (40% of 127) eligible, 41 enrolled in the extension study, and 34 (27% of 127) were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events per hour; the percentage of patients who met criteria for success was not reported. The arousal index was modestly decreased (from 23.9 to 19.0). Over 12 months of treatment, the ESS decreased from 11.1 to 6.0. The median percentage of reported nights used (entire night) was 89.3%. Device-related adverse events were reported by 42% of patients, and the most frequently reported adverse events were difficulty exhaling, nasal discomfort, dry mouth, headache, and insomnia. This open-label extension study is limited by the inclusion of responders only and by the potential for a placebo effect on the ESS. However, the data suggest that some patients may respond to this device, and the patient compliance data might indicate a positive effect on daytime sleepiness that leads to continued use of the device in about one in four patients. Additional controlled studies are needed to distinguish between these alternatives. Kureshi et al reported a small (n=14) double-blind, pilot, crossover RCT on EPAP in children to evaluate efficacy and compliance with this new treatment. PSG with EPAP or a placebo device Page 24 of 42

25 showed a significant mean improvement in obstructive apnea index with EPAP (index of 0.6 vs 4.2, p = 0.01), but responses were variable (three not improved and two worsening). No other measures were statistically significant in this small study. For the responders who utilized the devices at home for 30 days, adherence was 83% of nights. The Epworth Sleepiness scale improved from 11 to 7 (p=0.031) and the Obstructive Sleep Apnea -18 questionnaire improved from 50 to 39 (p = 0.028). Other outcome measures were not significantly improved. Positive Airway Pressure Bi-level positive airway pressure-spontaneous timed (BiPAP S/T) is not appropriate for obstructive apnea. It is designed to assist ventilation noninvasively. It is sometimes used for patients with neuromuscular respiratory insufficiency or restrictive lung disease from thoracic wall deformity and chronic respiratory failure due to chronic obstructive pulmonary disease (COPD). Other methods of assist ventilation that may be used invasively are not appropriate for obstructive sleep apnea. Additional information regarding BiPAP S/T is available on Blue Cross and Blue Shield of Alabama s medical policy #203, Respiratory Assist Device, Bi-level Pressure Capability, with Backup Rate Feature (BiPAP S/T). Auto-titrating continuous positive airway pressure (auto-cpap or APAP) utilizes a device that continually adjusts the level of pressure, as needed, to maintain airway patency. It has been investigated, both as a means to establish the required level of therapeutic "fixed" CPAP for long-term use, (as an alternative to sleep laboratory, technician- titrated CPAP), and as a longterm therapeutic alternative to fixed CPAP in adults. Surgical Treatment Surgical procedures include: uvulopalatopharyngoplasty (UPPP), laser-assisted uvulopalatoplasty (LAUP), radiofrequency ablation of palatal tissues, hypoglossal nerve stimulation and a variety of maxillofacial surgeries such as genioglossal advancement, hyoid suspension and mandibular-maxillary advancement (MMA). The uvulopalatopharyngoplasty (UPPP) is the most commonly performed procedure, involving surgical resection of the mucosa and submucosa of the soft palate, tonsillar fossa, and the lateral aspect of the uvula. The amount of tissue removed is individualized for each patient. This procedure enlarges the oropharynx but cannot correct obstructions in the hypopharynx. Additional procedures include hyoid suspensions, maxillary and mandibular osteotomies, or modification of the tongue. A 2009 systematic review by Franklin et al evaluated benefits and adverse effects of surgery for snoring and OSA. The authors found only a small number of randomized controlled trials (RCTs) that assessed surgical procedures for snoring or sleep apnea. Key findings are as follows: Results from 45 studies reporting adverse events revealed persistent side effects after uvulopalatoplasty (UPP) and uvulopalatopharyngoplasty (UPPP) in about half the patients. Difficulty swallowing, globus sensation, and voice changes were especially common. The authors concluded that additional research with RCTs of surgery other than UPP and UPPP is needed, as these surgical procedures are related to a high risk of adverse effects, especially difficulty swallowing. Four RCTs, rated as high quality, were identified for laser-assisted palatoplasty (LAUP) and radiofrequency ablation (RFA). Study results were mixed and inconclusive for Page 25 of 42

26 apnea/hypopnea index (AHI), and showed no benefit on daytime sleepiness or quality of life. Interpretation of this result is limited by the inclusion of studies with one-stage procedures and subjects whose main symptom was disruptive snoring. The relevant trials are described in greater detail next. Maxillomandibular Advancement An RCT that compared maxillomandibular advancement (MMA) to conservative management with ventilation was reported in Fifty patients with AHI greater than 30 were randomized to MMA or autotitrating positive airway pressure (APAP); there were no exclusions for body mass index (BMI). Blinding was not considered possible due to the types of treatment. No differences in outcomes were found between the groups. At baseline, AHI was 57 in the MMA group and 50 in the APAP group. At one-year follow-up, AHI had decreased to 8 following surgery and 6 with the use of APAP. The Epworth Sleepiness Scale (ESS) decreased from 11.6 to 7.7 with MMA and from 11.2 to 5.9 with APAP. Three patients were not able to tolerate APAP and crossed over to MMA (analysis of crossovers not clear), four required more than three consultations, and three required a different mask. In the surgery group, seven patients reported a persistent but not disturbing paresthesia around the chin and six reported slight to minimal malocclusion. Satisfaction with surgery was reported to be high (88% of patients reported satisfaction > 90% of 100, compared with 56% for APAP). Adenotonsillectomy Three systematic reviews were published in 2009 on tonsillectomy for OSA in children. Kuhle et al reviewed randomized trials on interventions for children with OSA. The single RCT on surgical interventions that was identified compared RFA of the tonsils with conventional adenotonsillectomy. Both procedures were found to reduce the Respiratory Disturbance Index (RDI; from 7.7 and 7.6/h to 0.3 and 1.6/h, respectively). Friedman et al performed a metaanalysis of 23 studies (1079 children with a mean age of 6.5 years) to evaluate success rates of tonsillectomy and adenoidectomy for pediatric OSA. The mean preoperative AHI was 18.6 and the mean postoperative AHI was 4.9, with a mean change after surgery of 12.4 events per hour. Although limited by heterogeneity, the success rate was found to be 66% when success was defined as an AHI less than 5 and 60% when success was defined as an AHI <1. Further analysis found that the success rate (AHI <5) was only 39% in children with comorbidities such as obesity compared with a 74% success rate observed in uncomplicated patients. Because of likely publication bias, the authors concluded that these rates should be considered an upper limit of success. Costa and Mitchell also reported lower efficacy in obese children from their metaanalysis of four studies reporting on this population. The mean pre- and postoperative AHI was 29.4 and 10.3, respectively. Following adenotonsillectomy, 49% of obese children had a postoperative AHI of less than 5, 25% had a postoperative AHI <2, and 12% had a postoperative AHI <1. Laser-Assisted Uvulopalatoplasty Ferguson et al reported on a trial that randomized 45 subjects with mild-to-moderate sleep apnea (defined as an AHI ranging between 10 and 27 per hour) to either uvulopalatoplasty (LAUP) or no treatment. The LAUP procedure was repeated at one- to two-month intervals until the snoring was significantly reduced, or no more tissue could safely be removed, or the patient refused Page 26 of 42

27 further procedures. The primary outcome measurement was the reduction in AHI in the LAUP group versus the control group. An AHI of less than 10 was considered a successful treatment. In the treatment group, 24% were considered treatment successes and 76% were failures. In the control group (who received no therapy), 16.7% were considered treatment successes. The authors concluded that LAUP can be effective in some patients, but the reduction in AHI and the level of symptomatic improvement were minor overall. Tongue Suspension In 2013, Handler et al reported a systematic review of tongue suspension versus hypopharyngeal surgery for the treatment of OSA. The review included 27 studies reporting on four separate procedures; tongue suspension alone, tongue suspension + UPPP, genioglossus advancement (GA) + UPPP, and genioglossus advancement + hyoid suspension (GAHM) + UPPP. A successful treatment was defined as a 50% decrease in the RDI or AHI and a postoperative RDI or AHI less than 20. Tongue suspension alone (6 studies, 82 patients) had a success rate of 36.6%, while the success rate of tongue suspension + UPPP (8 studies, 167 patients) was 62.3%. A success rate of 61.1% was found for GA + UPPP (7 studies, 151 patients) and for GAHM + UPPP (12 studies, 467 patients). The adverse effects of tongue suspension appear to be milder than GA or GAHM and are reversible. Most of the studies identified in this review were level IV evidence (case series). One level II RCT included in the systematic review compared two tongue base surgeries (RFA or tongue-base suspension) combined with UPPP for moderate to severe sleep apnea (AHI >15). In the tongue suspension + UPPP group (n=28), the mean AHI decreased from 33.1 to 15.1 events per hour. The success rate for the combined procedure (defined as a >50% reduction, final AHI <15, and ESS <11) was 57.1%, compared with a success rate of 51.7% in the UPPP + RFA group (p=0.79). Body mass index (BMI) was the main predictor of success, with a success rate for tongue base suspension + UPPP of only 10% in patients with a BMI between 30 and <35 kg/mg2. Morbidity and complications were higher with the tongue suspension procedure compared with RFA. RCTs are needed to determine whether adding tongue suspension to UPPP improves the net health outcome compared to treatment with UPPP alone. Radiofrequency Ablation of Palatal Tissues and the Tongue The policy on radiofrequency volumetric tissue reduction (i.e., Somnoplasty ) was originally based on a 2000 TEC Assessment of four primary studies on palatal RFA and one study on tongue base RFA. All studies were nonrandomized and enrolled preselected patients. The Assessment concluded that data were inadequate to make a conclusion at that time. In 2008, Farrar et al published a meta-analysis of RFA for the treatment of OSA in patients with a RDI of 5 or more. Sixteen studies met the inclusion criteria; three were randomized and 13 were nonrandomized. Six studies treated both the base of the tongue and the soft palate, two treated the soft palate only, and eight ablated the base of the tongue only. The population was in the overweight, but not obese, category, with a mean BMI of In half of the studies, the average baseline RDI was less than 30, and in six of the studies, the average baseline ESS was <10. The meta-analysis indicated a 31% reduction in both ESS and RDI. The lowest oxygen Page 27 of 42

28 saturation level was not improved by RFA. The mean number of treatments required for patient satisfaction was 3.7 for the soft palate, 4.3 for the base of the tongue, and 4.8 for both sites (range, 3-7). Complications were noted in 4% of patients; two tongue abscesses progressed to airway obstruction requiring tracheotomy. Only two of the studies provided two-year follow-up, with a 32% reduction in ESS and a 45% reduction in RDI. The number of patients who were successfully treated (e.g., 50% reduction in RDI) was not reported. This meta-analysis is limited by the inclusion of poor quality uncontrolled studies. Higher quality studies are described next. A single-blinded RCT of single-stage radiofrequency surgery of the soft palate was reported in Thirty-two patients with mild OSA (AHI between 5 and 15), habitual snoring, and excessive daytime sleepiness according to subjective patient history, were randomized to a single session of RFA or sham ablation. There was no difference between the groups for baseline to posttreatment (4-6 months) changes in the ESS (3-point improvement in ESS for both groups), reports of snoring (1 point improvement in both groups), AHI (no clinically significant change), or any other outcome measure. None of the patients reported any treatment-related symptoms or complications four months after treatment. Results of this small single-blinded RCT indicate that single-stage RFA of the soft palate is not effective for the treatment of mild OSA. An RCT from 2009 compared efficacy and side effects of two tongue-based procedures (RFA or tongue-base suspension) when combined with UPPP in 57 patients with moderate-to-severe sleep apnea (AHI 15). Patients with a BMI of 35 kg/m2 or greater were excluded. Although interpretation of results is limited by the lack of a control group treated with UPPP alone, the success rate for combined RFA + UPPP (defined as a 50% reduction and final AHI <15) was 51%. BMI was the main predictor of success, with success rates of only 12.5% in patients with a BMI between 30 and less than 35 kg/mg2. A 2008 retrospective cohort study assessed the incremental value of RFA of the tongue in combination with UPPP. All patients with both palatal and retroglossal obstruction, an RDI between 5 and 50 and no previous OSA surgery were included in the study. Seventy-five patients meeting the inclusion criteria had been treated with UPPP during the three-year period, 38 had UPPP alone, 37 had UPPP plus RFA. The groups were comparable for age, gender, BMI, AHI, and mean oxygen saturation (SaO 2 ); however, no details were provided regarding the choice of procedure. With surgical success rate defined as more than 50% reduction of the AHI and AHI below 20, the success rate was 42% with UPPP alone and 49% with RFA (not significantly different). Two patients had an additional RFA treatment. No major complications were observed. The study concluded that the addition of RFA to UPPP resulted in only limited improvement, but there was no major downside to it. A 2003 study by Woodson et al compared the use of multilevel RFA with the current criterion standard of continuous positive airway pressure (CPAP) in an RCT. The study included patients with mild obesity levels (BMI 34 kg/m2) who had mild to moderate sleep apnea with an AHI between 10 and 30. Statistically significant improvement was noted with RFA and CPAP over placebo in OSA-specific quality of life using the Functional Outcomes of Sleep Questionnaire. However, the small size of the trial resulted in most outcomes not being statistically significant. The same group of authors reported a further subgroup analysis from the same trial, focusing on Page 28 of 42

29 the 26 patients randomized to the RFA arm of the trial to determine whether additional treatments improved outcomes. Specifically, the authors focused on multilevel treatments on various combinations of palatal and tongue tissues. Greater improvements in quality of life were reported for those patients who had a total of five treatments compared with three. Another subgroup analysis focused on multilevel treatments in 26 patients. This subgroup likely contains overlapping patients with the previous report, and the results were similar; i.e., greater improvements were reported in those patients who had a total of five treatments. Palatal Stiffening Procedures Cautery-Assisted Palatal Stiffening Operation There is limited evidence regarding cautery-assisted palatal stiffening operation (CAPSO) in patients with clinically significant OSA; most studies on CAPSO focus on patients with simple snoring (AHI <5) or mild sleep apnea (AHI <15). In 2000, Wassmuth et al reported a case series of 25 patients with OSA who underwent CAPSO. Responders were defined as patients who had a reduction in AHI of at least 50%. Mean AHI improved from 25.1±12.9 to 16.6±15.0. The broad confidence intervals limit interpretation of these data. Palatal Implants In a 2008 trial by Steward et al, 100 patients with mild to moderate OSA and suspected retropalatal obstruction were randomly assigned to palatal implants or sham placebo. Patients with BMI greater than 32 kg/m2 were excluded from the study. About 1000 patients were evaluated to identify the 100 study patients. At three months follow-up, the average AHI increased in both groups from a baseline of about 17, although the increase was greater in the placebo group (8.9 vs 2.9, respectively). A reduction in AHI by at least 50% or to below 20 was more common in the implant group (26% vs 10%, respectively; p=0.05). Improvement in ESS did not differ from that of sham (p=0.62). Partial implant extrusion occurred in two patients (4%). Friedman et al reported an industry-sponsored randomized double-blind, sham-controlled trial of palatal implants in 62 patients with symptoms of OSA. Other inclusion criteria included: Friedman tongue position I, II, or III; diagnosis of mild to moderate OSA (AHI 5 and <40) on baseline polysomnography (PSG); a soft palate of two cm or more but less than 3.5 cm; and BMI less than 32 kg/m2. AHI at baseline was 23.8 events per hour in the implant group and 20.1 in controls. Seven patients did not return for repeat PSG and were considered treatment failures in the intention-to-treat analysis. At three-month follow-up, the AHI improved to 15.9 events per hour in the implant group but did not change significantly in the controls (21.0). The ESS improved from 12.7 to 10.2 in the implant group and did not change significantly in the controls (11.7 to 11.1). With success defined as an AHI reduction of 50% or more and AHI less than 20, palatal implantation resulted in the successful treatment of 41.9% of implanted patients compared with 0% of controls. Two patients had partial implant extrusion. In 2012, Maurer et al reported a randomized double-blind, sham-controlled trial of the Pillar palatal implant in 20 patients with mild to moderate OSA because of palatal obstruction. At 90 days, the AHI in the treatment group improved from 19.1 to 8.2 events per hour and lowest oxygen saturation improved from 82.8% to 88.3%. These measures did not improve significantly Page 29 of 42

30 in the control group, and there was no significant difference in outcomes between the implant and control groups in this small trial. The ESS did not improve significantly in either group. There are also uncontrolled series of patients treated with palatal implants. For example, Walker et al published 90-day and 15-month follow-up from a multicenter study on palatal implants (Pillar System) in 63 subjects. The AHI decreased from a baseline of 25 to 22 in the 53 patients (84%) who were evaluated at 90 days. Twenty-two patients (35%) were available for the followup study; 13 had shown a decrease in AHI (from a baseline of 20 to 13) at 90 days. Of these, 10 (77% of the 13) maintained the decrease at 15 months. The nine patients whose AHI had not improved at 90 days had no subsequent improvement at the extended follow-up. Mean snoring was rated as eight at baseline (visual analog scale), and four at both 90 days and 15 months. Subjective daytime sleepiness measured by the ESS was reduced at 90 days (11 to 7) but returned to a score of 11 at the longer follow-up. In addition to the very large loss to follow-up, questions remain about the clinical significance of a three- to seven-point improvement in AHI. Neruntarat reported a case series with a minimum of 24-month follow-up. This study included 92 patients with mild to moderate OSA (AHI 30 with daytime sleepiness or disturbed sleep) who had received palatal implants after failed medical management. At baseline, the mean AHI was 21.7 events per hour, and the lowest oxygen saturation was 87.4%. At mean 28.9-month followup, the AHI had decreased to 10.8, and the lowest oxygen saturation improved to 89.2%. Sleep efficiency improved from 80.6% to 87.2%, and the ESS score improved from a mean of 12.3 to 7.9. Implant extrusion occurred in seven patients (7.6%), and palatal abscess occurred in one patient (1.1%). Section Summary Palatal Implants The literature on palatal implants consists of three RCTs and additional case series with mediumterm follow-up. Evidence from sham-controlled trials shows a statistically significant but modest reduction in AHI and improvement in lowest oxygen saturation compared with placebo, with limited effects on daytime sleepiness. Additional study is needed to determine whether there is a defined subset of patients who might benefit from this procedure. Studies with longer-term follow-up are also needed to evaluate the potential for extrusion of the implants at longer time intervals. Hypoglossal Nerve Stimulation In 2014, the STAR Trial Group reported 12-month outcomes from a multicenter single-arm study (NCT , n=126) of the Inspire Upper Airway Stimulation system. Patients were included if the AHI score from the screening PSG was at least 20 and no more than 50 events per hour. At 12 months after implantation 66% of the participants met the co-primary outcome of at least a 50% decrease in AHI with a final AHI of less than 20 events per hour, and 75% met the co-primary outcome of a reduction in the oxygen desaturation index score of 25% or more. The median AHI decreased from 29.3 to 9.0 events per hour (mean, 32.0 to 15.3) and the oxygen desaturation index score (number of times per hour that SO2 drops by 4% or more) decreased from 25.4 to 7.4 events per hour (mean, 29.9 to 13.9). The mean ESS decreased from 11.6 to 7.0. The first 46 patients who responded to therapy were then randomized to either continued therapy or withdrawal from therapy. After seven days, AHI of the continued treatment group remained stable from a mean of 7.2 to 8.9 events per hour, whereas the mean AHI in the withdrawal group Page 30 of 42

31 increased from 7.6 to Eighteen percent of participants had temporary tongue weakness and 21% reported tongue soreness, including abrasion, which resulted from stimulation-induced tongue motion over the lower teeth. A series of 31 patients implanted with the Apnex hypoglossal nerve stimulation system (HGNS ) was reported in Apnex Medical terminated their pivotal study and ceased operations when it was determined that the trial was unlikely to meet its primary end point. A 2015 systematic review identified six case series with a total of 200 patients treated with hypoglossal nerve stimulation. Two series were identified on the Inspire II System, and included the STAR trial described above. Three series were identified with the HGNS system, and included the study of 31 patients described above. One series of 13 patients was identified with the Aura6000 System (ImThera Medical). When data were combined for meta-analysis, AHI and Oxygen Desaturation Index (ODI) improved by a little over 50% (e.g., AHI from 44 to 20, ODI from 21 to 10), and the ESS improved from 12 to seven. All of the included studies described minor complications such as tongue weakness, tongue soreness, pain/swelling at the neck incision, fever, and lack of tongue response to stimulation. Of the 200 patients, nine (4.5%) had serious device-related adverse events that led to removal of the stimulator. Additional study with RCTs is needed to permit conclusions regarding the effect of this treatment on health outcomes. Practice Guidelines and Position Statements American Academy of Pediatrics The American Academy of Pediatrics (AAP) published a 2012 guideline on the diagnosis and management of uncomplicated childhood OSA associated with adenotonsillar hypertrophy and/or obesity in an otherwise healthy child treated in the primary care setting, which updates AAP s 2002 guidelines. AAP recommends that all children/adolescents should be screened for snoring, and PSG should be performed in children/adolescents with snoring and symptoms/signs of OSA as listed in the guideline. If PSG is not available, an alternative diagnostic test or referral to a specialist may be considered. The estimated prevalence rates of OSA in children/adolescents range from 1.2% to 5.7%. Adenotonsillectomy is recommended as the first line of treatment for patients with adenotonsillar hypertrophy, and patients should be reassessed clinically postoperatively to determine whether additional treatment is required. High-risk patients should be reevaluated with an objective test or referred to a sleep specialist. CPAP is recommended if adenotonsillectomy is not performed or if OSA persists postoperatively. Weight loss is recommended in addition to other therapy in patients who are overweight or obese, and intranasal corticosteroids are an option for children with mild OSA in whom adenotonsillectomy is contraindicated or for mild postoperative OSA. American Academy of Otolaryngology - Head and Neck Surgery The American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) has a 2014 revised policy statement on surgical management of OSA. Procedures the AAO-HNS supports as effective and not considered investigational when part of a comprehensive approach in the medical and surgical management of adults with OSA include tracheotomy, nasal and pharyngeal airway surgery, tonsillectomy and adenoidectomy, palatal advancement, UPPP, UPP Page 31 of 42

32 (including laser assisted and other techniques), genioglossal advancement, hyoid myotomy, midline glossectomy, tongue suspension, and maxillary and mandibular advancement. Links are provided to position statements on nasal surgery and OSA, midline glossectomy, tongue suspension, genioglossus advancement, hyoid myotomy, and UPPP. In the 2012 position statement on UPPP, AAO-HNS concluded that UPPP is a valid treatment of OSA. Either simultaneous or serial surgical procedures are considered medically necessary and effective for patients with mild to severe obstructive sleep apnea. A 2012 position statement recommends tongue suspension as effective when considered as part of a comprehensive approach in the medical and surgical management of adult patients with mild OSA and in adult patients with moderate and severe OSA who have evidence of tongue base or associated hypopharyngeal obstruction. AAO-HNS notes that results appear to diminish in obese patients, and this technique should receive a weaker recommendation for these patients. American Society for Metabolic and Bariatric Surgery In 2012, the American Society for Metabolic and Bariatric Surgery published guidelines on the perioperative management of OSA. The guideline states that OSA is strongly associated with obesity with the incidence of OSA in the morbidly obese population being reported to be between 38% and 88%. They recommend bariatric surgery be the initial treatment of choice for OSA in this population, as opposed to surgical procedures directed at the mandible or tissues of the palate. American Academy of Sleep Medicine and American Academy of Dental Sleep Medicine In 2015, the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) published a Clinical Practice Guideline on the treatment of OSA and snoring with oral appliance therapy. The AASM and AADSM provided a recommendation of standard that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patient with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy. The quality of evidence was rated as moderate. Guideline recommendations were provided for the use of custom, titratable appliance over non-custom oral devices, that qualified dentists provide oversight, that sleep physicians conduct follow-up sleep testing to improve or confirm treatment efficacy, and that patients return for periodic office visits with a qualified dentist and a sleep physician. American College of Physicians 2014 Guidelines on the diagnosis of OSA in adults from the American College of Physicians (ACP) recommend that clinicians should target their assessment of OSA to individuals with unexplained daytime sleepiness. ACP recommends PSG for diagnostic testing in patients suspected of OSA, and portable sleep monitors in patients without serious comorbidities as an alternative to PSG when PSG is not available for diagnostic testing (weak recommendation, moderate-quality evidence). Inconclusive areas of evidence included preoperative screening for OSA, phased testing for the diagnosis of OSA, and the utility of portable monitors for diagnosis OSA in patients with comorbid conditions Guidelines on the management of OSA in adults from the ACP recommend that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight (strong recommendation, low-quality evidence). ACP recommends CPAP as initial therapy for patients Page 32 of 42

33 diagnosed with OSA (strong recommendation; moderate-quality evidence), and mandibular advancement devices as an alternative therapy to CPAP for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with CPAP (weak recommendation, low-quality evidence). U.S. Preventive Services Task Force Recommendations Not applicable. Key Words: Uvulopalatopharyngoplasty, UPPP, UP-3, laser-assisted palatoplasty, LAUP, continuous positive airway pressure, CPAP, Bi-level positive airway pressure, BiPAP, somnoplasty, radiofrequency ablation, obstructive sleep apnea syndrome, OSA, OSAS, upper airway resistance syndrome, UARS, uvulectomy, genioglossal advancement, hyoid suspension and myotomy, maxillomandibular advancement, palatal implants, Pillar, snoring, cautery-assisted palatal stiffening, auto-titrate CPAP, auto-adjusting CPAP, APAP, oral appliances, OA, mandibular repositioning device, MRA, atrial pacing, BiPAP BiFlex, Repose, C-Flex, A-Flex, Auto-CPAP, PROVENT EPAP, nasal expiratory positive airway pressure, Winx Sleep Therapy System, ApniCure, Oral Pressure Therapy (OPT), Inspire II Upper Airway Stimulation System, hypoglossal nerve stimulation Approved by Governing Bodies: The Somnoplasty System received FDA (510K) approval in September It is intended for use in the coagulation of soft tissue in the inferior turbinates for the treatment of chronic hypertrophic rhinitis. The Pillar Palatal Implant System (Restore Medical, St. Paul, MN) is an implantable device that has been cleared by the FDA 501(k) process in late The labeled indication of the device is as follows: The Pillar Palatal Implant System is intended for the reduction of the incidence of airway obstructions in patients suffering from mild to moderate OSA (obstructive sleep apnea). PROVENT (Ventus Medical) is a nasal expiratory resistance valve (EPAP) which received marketing clearance as a 510K through the FDA in 2010 for the treatment of OSA. PROVENT is a single use device containing valves that are inserted into the nostrils and secured with tape. Airvance (Medtronic; formally the Repose Bone Screw System from Influence) was cleared for marketing through the 510(k) process in 1999 with intended use for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of OSA and/or snoring. The Encore Tongue Suspension System (Siesta Medical) received clearance for marketing in 2011, citing the PRELUDE III Tongue Suspension System (Siesta Medical) as a predicate device. FDA product codes: LRK, ORY. Page 33 of 42

34 The Inspire II Upper Airway Stimulation System (Inspire Medical Systems) received FDA approval in May In 2011, Apnex Medical received FDA approval to conduct a randomized investigational device exemption trial for the Hypoglossal Nerve Stimulation (HGNS ) System. The trial was terminated and Apnex Medical has ceased operations. In 2014, ImThera Medical received FDA approval for an IDE trial with the aura6000. Winx Sleep Therapy System, received 510 K clearance from the FDA on May 18, 2012, for the treatment of obstructed sleep apnea. Benefit Application: Coverage is subject to member s specific benefits. Group specific policy will supersede this policy when applicable. ITS: Home Policy provisions apply FEP: Special benefit consideration may apply. Refer to member s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Effective October 1, 2011, Monsanto Group numbers 01342, 39317, 47426, and 50164: special benefit considerations apply. Effective October 1, 2010, electronic pre-determinations will be available for Alabama providers. The online pre-determination form can be accessed through ProviderAccess on the Blue Cross and Blue Shield of Alabama web site. Coverage for oral appliances is limited to one appliance every three years and repairs are covered as necessary. Inclusive in the global fee for the device: initial evaluation, oral/dental impressions, diagnostic casting, fabrication of the application, initial fitting, patient education and teaching of use of the device and 90 days for follow-up office visits and adjustment of appliance/device. Current Coding: CPT codes: Genioplasty; augmentation (autograft, allograft, prosthetic material) Genioplasty; sliding osteotomy, single piece Genioplasty; sliding osteotomies, two or more osteotomies (e.g., wedge excision or bone wedge reversal for asymmetrical chin) Genioplasty; sliding, augmentation with interpositional bone grafts (includes obtaining autografts) Osteotomy, mandible, segmental with genioglossal advancement Unlisted craniofacial and maxillofacial procedure Hyoid myotomy and suspension Glossectomy; less than one-half tongue Glossectomy; hemiglossectomy Page 34 of 42

35 41512 Tongue base suspension, permanent suture technique Submucosal ablation of the tongue base, radiofrequency, one or more sites, per Resection of palate or extensive resection of lesion Uvulectomy, excision of uvula Palatopharyngoplasty (e.g., uvulopalatopharyngoplasty, uvulopharyngoplasty) Unlisted procedure, Palate or Uvula HCPCS Codes: A7047 Oral interface used with respiratory suction pump, each (Effective 01/01/2014) E0470 Respiratory assist device, bi-level pressure capability, without backup rate feature, used with non-invasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) E0471 Respiratory assist device, bi-level pressure capability, with back-up rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) E0472 Respiratory assist device, bi-level pressure capability, with backup rate feature, used with invasive interface, e.g., tracheostomy tube (intermittent assist device with continuous positive airway pressure device) E0485 Oral device/appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, prefabricated, includes fitting and adjustment. E0486 Oral device/appliance used to reduce upper airway collapsibility, adjustable or on-adjustable, custom fabricated, includes fitting and adjustment E0561 Humidifier, non-heated, used with positive airway pressure device E0562 Humidifier, heated, used with positive airway pressure device E0601 Continuous airway pressure (CPAP) device-(this code should also be used to bill the APAP devices.) E1399 Unlisted code This should be used to report the Winx system and all associated supplies K0553 Combination oral/nasal mask, used with continuous positive airway pressure device, each K0554 Oral cushion for combination oral/nasal mask, replacement only, each K0555 Nasal pillows for combination oral/nasal mask, replacement only, pair S2080 (Invalid for Medicare 2002) Laser-assisted Uvulopalatoplasty (LAUP) References: 1. American Academy of Otolaryngology Head and Neck Surgery. Surgical management of obstructive sleep apnea. 1998, Page 35 of 42

36 2. American Academy of Otolaryngology-Head and Neck Surgery. Position Statement on Uvulopalatopharyngoplasty American Academy of Otolaryngology-Head and Neck Surgery. Position Statement on Tongue Suspension American Academy of Otolaryngology - Head and Neck Surgery. Surgical Management of Obstructive Sleep Apnea American Academy of Pediatrics. AAP recommends pediatricians screen children for snoring, News Release, April 1, 2002, 6. American Academy of Pediatrics. Clinical practice guideline: Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics, April 2002, Vol. 109, No. 4, pp American Society for Metabolic & Bariatric Surgery. Peri-operative management of obstructive sleep apnea asmbs.org/2012/03/peri-operative-management-ofobstructive-sleep-apnea/. 8. Back LJ, Liukko T, Rantanen I, et al. Radiofrequency surgery of the soft palate in the treatment of mild obstructive sleep apnea is not effective as a single-stage procedure: A randomized single-blinded placebo-controlled trial. Laryngoscope, August 2009; 119(8): Balk EM, Moorthy D, Obadan NO et al. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Comparative Effectiveness Review No. 32 (Prepared by Tufts Evidencebased Practice Center under Contract No ) AHRQ Publication No. 11- EHC052-EF. Rockville MD: Agency for Healthcare Research and Quality Jul Barthel, Steven W. and Strome, Marshall. Snoring, obstructive sleep apnea, and surgery. Medical Clinics of North America, January 1999, Vol. 83, No Berry RB, Kryger MH, Massie CA. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. Sleep 2011; 34(4): Certal VF, Zaghi S, Riaz M, et al. Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: A systematic review and meta-analysis. Laryngoscope. May 2015; 125(5): Cummings: Otolaryngology: Head & Neck Surgery, 4 th edition. Treatment. 14. DeRowe A, Gunther E, et al. Tongue-base suspension with a soft tissue-to-bone anchor for obstructive sleep apnea: Preliminary clinical results of a new minimally invasive technique. Otolaryngol Head Neck Surg, January 2000; 122(1): (Abstract) 15. Eastwood PR, Barnes M, Walsh JH et al. Treating Obstructive Sleep Apnea with Hypoglossal Nerve Stimulation. Sleep 2011; 34: Epstein LJ, Kristo d, Strollo PJ et al. Clinical Guideline for Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. J Clin Sleep Med 2009; 5(3): Farrar J, Ryan J, Oliver E and Gillespie MB. Radiofrequency ablation for the treatment of obstructive sleep apnea: A meta-analysis. Laryngoscope, October 2008; 118(10): Ferguson KA, Heighway K and Ruby R. A randomized trial of laser-assisted uvulopalatoplasty in the treatment of mild obstructive sleep apnea. Am J Respir Crit Care Med 2003, Vol. 167, pp Page 36 of 42

37 19. Ferguson Kathleen A, et al. Oral appliances for snoring and obstructive sleep apnea: A review. SLEEP 2006, Vol. 29, No Fernandez-Julian E, Munoz N, et al. Randomized study comparing two tongue base surgeries for moderate to severe obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg, June 2009; 140(6): Franklin KA, Anttila H, Axelsson S, et al. Effects and side-effects of surgery for snoring and obstructive sleep apnea A systematic review. SLEEP 2009; 32(1): Friedman M, Schalch P, Lin HC et al. Palatal implants for the treatment of snoring and obstructive sleep apnea/hypopnea syndrome. Otolaryngol Head Neck Surg 2008; 138(2): Gay Peter, et al. Evaluation of positive airway pressure treatment for sleep related breathing disorders in adults. SLEEP 2006, Vol. 29, No Guyette Robert F and Waite Peter D. Adjunctive surgical procedures in obstructive sleep apnea. Oral and Maxillofacial Surgery Clinics of North America, May 1995, Vol. 7, No. 2, pp Handler E, Hamans E, Goldberg AN et al. Tongue suspension: an evidence-based review and comparison to hypopharyngeal surgery for OSA. Laryngoscope 2014; 124(1): Health Technology Advisory Committee. Treatment of obstructive sleep apnea in adults: Executive summary, June 1999, Ho WK, Wei WI, and Chung KF. Managing disturbing snoring with palatal implants. A pilot study. Arch Otolaryngol Head Neck Surg 2004; 130: Kezirian EJ, Goding GS, Jr., Malhotra A, et al. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res. Feb 2014; 23(1): Krahn AD, Yee R, Erickson MK, et al. Physiologic pacing in patients with obstructive sleep apnea: A prospective, randomized crossover trial. J Am Coll Cardiol, January 2006; 47(2): Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med 2011; 7(5): B. 31. Kuhle S, Urschitz MS, et al. Interventions for obstructive sleep apnea in children: A systematic review. Sleep Med Rev, April 2009; 13(2): Kuhnel TS, et al. Morphological changes of the posterior airway space after tongue base suspension. Laryngoscope, March 2005; 115(3): (Abstract) 33. Kuhnel TS, Hein G, Hohenhorst W, and Maurer JT. Soft palate implants. A new option for treating habitual snoring. Eur Arch Otorhinolaryngol 2004; Aug Kureshi SA, Gallagher PR, McDonough JM, et al. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome. J Clin Sleep Med. 2014;10(6): Kushida Clete A, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances: An update for SLEEP 2006, Vol. 29, No Kushida Clete A, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. SLEEP 2006, Vol. 29, No Larrosa F, Hernandez L, Morello A, et al. Laser-assisted uvulopalatoplasty for snoring: Does it meet the expectations? Eur Respir J 2004; 24: Page 37 of 42

38 38. Lee NR. Current medical and surgical management of sleep related breathing disorders. Oral and Maxillofacial Surgery Clinics of North America, August 2002, Vol. 14, No Lee NR. Genioglossus muscle advancement techniques for obstructive sleep apnea. Oral Maxillofacial Surg Clin N Am, 14 (2002); Littner Michael, Kushida Clete A, Hartse Kristyna, et al. Practice parameters for the use of laser-assisted uvulopalatoplasty: An update for SLEEP, 2001, Vol. 24, No Loube Daniel I. Technologic advances in the treatment of obstructive sleep apnea syndrome. Chest, November 1999, Vol. 116, No Mair EA and Day RH. Cautery-assisted palatal stiffening operation. Otolaryngol Head Neck Surg, April 2000; 122(4): Marcus Carol J. Letters to the Editor: Clinical practice guideline: Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics, December 2002, Vol. 110, No Marcus CL, Brooks LJ, Draper KA et al. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics (3):e //pediatrics.aappublications.org/content/130/3/576.full.pdf+html?sid=d61600bf d96-43f0421d186a. 45. Masa JF, Jimenez A, Duran J, et al. Alternative methods of titrating continuous positive airway pressure. A large multicenter study. Am J Respir Crit Care Med. 2004; 170: Maurer JT, Sommer JU, Hein G et al. Palatal implants in the treatment of obstructive sleep apnea: a randomised, placebo-controlled single-centre trial. Eur Arch Otorhinolaryngol Maurer JT, Verse T, Stuck BA, et al. Palatal implants for primary snoring: Short-term results of a new minimally invasive surgical technique. Otolaryngol Head Neck Surg 2005; 132: McMains K Christopher and Terris David J. Evidence-based medicine in sleep apnea surgery. Otolaryngologic Clinics of North America, June 2003, Vol. 36, No Messner Anna H. Treating pediatric patients with obstructive sleep disorders: An update. Otolaryngologic Clinics of North America, June 2003, Vol. 36, No Miller FR, Watson D and Malis D. Role of the tongue base suspension suture with The Repose System bone screw in the multilevel surgical management of obstructive sleep apnea. Otolaryngol Head Neck Surg, April 2002; 126(4): (Abstract) 51. Mulgrew AT, Fox N, Ayas NT, et al. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Int Med. 2007; 146(3): Mutter TC, Chateau D, Moffatt M, et al. A matched cohort study of postoperative outcomes in obstructive sleep apnea: could preoperative diagnosis and treatment prevent complications? Anesthesiology. Oct 2014; 121(4): Nelson Lionel M. Combined temperature-controlled radiofrequency tongue reduction and UPPP in apnea surgery. ENT Journal, September 2001, Vol. 80, No Neruntarat C. Long-term results of palatal implants for obstructive sleep apnea. Eur Arch Otorhinolaryngol 2011; 268(7): Omur M, Ozturan D, et al. Tongue base suspension combined with UPPP in severe OSA patients. Otolaryngol Head Neck Surg, August 2005; 133(2): (Abstract) Page 38 of 42

39 56. Operation for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg 2000; 123: Pang KP and Terris DJ. Modified cautery-assisted palatal stiffening operation: New method for treating snoring and mild obstructive sleep apnea. Otolaryngol Head Neck Surg, May 2007; 136(5): Powell Nelson B, Riley Robert W and Guilleminault Christian. Radiofrequency tongue base reduction in sleep-disordered breathing: A pilot study. Otolaryngology-Head and Neck Surgery, May 1999, Vol. 120, No. 5, pp 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 Journal of Clinical Sleep Medicine 2015; 11(7): Respironics, Inc. Suggested protocol for initiation of the BiPAP S/T-D 30 Ventilatory Support System, March 27, Schmidt-Nowara, Wolfgang Lowe Alan, et al. Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. SLEEP, 1995; 18(6): Schwab R J, Kim C, Siegel L C, et al. Mechanism of action of a novel device using oral pressure therapy (OPT) for the treatment of OSA. Am J Respir Crit Care Med 185; 2012:A Schwartz AR, Bennett ML, Smith PL et al. Therapeutic Electrical Stimulation of the Hypoglossal Nerve in Obstructive Sleep Apnea. Arch Otoloryngol Head Neck Surg. 2001; 127: Schwartz AR, Barnes M, Hillman D et al. Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea. Am J Respir Crit Care Med 2012; 184(4): Simantirakis EN, Schiza SE, et al. Atrial overdrive pacing for the obstructive sleep apneahypopnea syndrome. NEJM, December 2005; 353(24): Somers VK, White DP, Amin R, et al. Sleep apnea and cardiovascular disease: An American Heart Association/American College of Cardiology Foundation Scientific Statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing in Collaboration with the National Heart, Lung, and Blood Institute National Center on Sleep Disorders Research (National Institutes of Health. JACC 2008; 52: Sorrenti G, Piccin O, Latini G, et al. Tongue base suspension technique in obstructive sleep apnea: Personal experience. Acta Otorhinolaryngol Ital, August 2003; 23(4): (Abstract) 68. Steward DL, Huntley TC, et al. Palate implants for obstructive sleep apnea: Multiinstitution, randomized, placebo-controlled study. Otolaryngol Head Neck Surg, October 2008; 139(4): Steward DL, Weaver EM and Woodson BT, et al. A comparison of radiofrequency treatment schemes for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg, May 2004; 130(5): Steward DL. Effectiveness of multilevel (tongue and palate) radiofrequency tissue ablation for patients with obstructive sleep apnea syndrome. Laryngoscope, December 2004; 114(12): Page 39 of 42

40 71. Strollo PJ, Jr., Soose RJ, Maurer JT et al. Upper-airway stimulation for obstructive sleep apnea. The N Engl J Med 2014; 370(2): Stuck BA, Sauter A, et al. Radiofrequency surgery of the soft palate in the treatment of snoring. A placebo-controlled trial. SLEEP, July 2005; 28(7): Thorpy Michael, Chesson Andrew, et al. Practice parameters for the treatment of snoring and obstructive sleep apnea with oral appliances. SLEEP, 1995;18: Thorpy Michael, Chesson Andrew, et al. Practice parameters for the treatment of obstructive sleep apnea in adults: The efficacy of surgical modifications of the upper airway. SLEEP, 1996; 19: van den Broek E, Richard W, van Tinteren H and de Vries N. UPPP combined with radiofrequency thermotherapy of the tongue base for the treatment of obstructive sleep apnea syndrome. Eur Arch Otorhinolaryngol, November 2008; 265(11): Van de Heyning PH, Badr MS, Baskin JZ et al. Implanted Upper Airway Stimulation Device for Obstructive Sleep Apnea. Laryngoscope 2012; 122: Vanderveken OM, Boudewyns A, Kashyap B et al. Cardiovascular Implications in the Treatment of Obstructive Sleep Apnea. J of Cardiovas. Transl. Res. 2011; 4: Vanderveken OM, Devolder A, Marklund M, et al. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. American Journal of Respiratory and Critical Care Medicine 2008, Vol. 178, pp Vicente E, et al. Tongue-base suspension in conjunction with uvulopalatopharyngoplasty for treatment of severe obstructive sleep apnea: Long-term follow-up results. Laryngoscope, July 2006; 116(7): (Abstract) 80. Vicini C, Dallan I, et al. Surgery vs. ventilation in adult severe obstructive sleep apnea syndrome. Am J Otolaryngol, Jan-Feb 2010; 31(1): Victor Lyle D. Obstructive sleep apnea. American Family Physician, November 15, 1999, Vol. 60, No Waite Peter D and Vilos Georgios A. Surgical changes of posterior airway space in obstructive sleep apnea. Oral Maxillofacial Surg Clin N Am, 14 (2002); Waite Peter D. Oral maxillofacial treatment of obstructive sleep apnea. Oral and Maxillofacial Surgery Clinics of North America, May 1995, Vol. 7, No Walker RP, Levine HL, Hopp ML and Greene D. Extended follow-up of palatal implants for OSA treatment. Otolaryngol Head Neck Surg, November 2007; 137(5): Walker RP, Levine HL, Hopp ML, et al. Palatal implants: A new approach for the treatment of obstructive sleep apnea. Otolaryngol Head Neck Surg, October 2006; 135(4): Wassmuth Z, Mair E, Loube D and Leonard D. Cautery assisted palatal stiffening for the treatment of obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg, July 2000; 123(1): Woodson B Tucker, et al. A multi-institutional study of radiofrequency volumetric tissue reduction for OSAS. Otolaryngology-Head and Neck Surgery, Vol. 125, No. 4, pp Woodson B Tucker. Soft tissue hypopharyngeal surgery for obstructive sleep apnea syndrome. Oral Maxillofacial Surgery Clin N Am, 14 (2002); Woodson BT, et al. Pharyngeal suspension suture with repose bone screw for obstructive sleep apnea. Otolaryngol Head Neck Surg, March 2000; 122(3): (Abstract) 90. Woodson BT, Steward DL, Weaver EM and Javaheri S. A randomized trial of temperaturecontrolled radiofrequency, continuous positive airway pressure, and placebo for obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg, June 2003; 128(6): Page 40 of 42

41 91. Woodson BT. A tongue suspension suture for obstructive sleep apnea and snorers. Otolaryngol Head Neck Surg, March 2001; 124(3): (Abstract) Policy History: Medical Policy Group, August 2002 Medical Policy Administration Committee, September 2002 Available for comment December 18, 2002-February 3, 2003 Medical Policy Group, October 2003 (1) Medical Policy Group, October 2004 Medical Policy Group, February 2005 (3) Medical Policy Administration Committee, July 2005 Available for comment August 6-September 19, 2005 Medical Policy Group, October 2005 (1) Medical Policy Administration Committee, October 2005 Available for comment October 24-December 7, 2005 Medical Policy Group, July 2006 (1) Medical Policy Administration Committee, August 2006 Available for comment August 4-September 18, 2006 Medical Policy Group, February 2007 Medical Policy Group, July 2007 (1) Medical Policy Administration Committee, July 2007 Available for comment July 27-August 15, 2007 Medical Policy Group, August 2007 (1) Medical Policy Administration Committee, August 2007 Available for comment August 16-September 29, 2007 Medical Policy Group, February 2009 (1) Medical Policy Group, March 2010 (3): Policy update regarding Medical management, and clarification, References added, Key Points Medical Policy Administration Committee April 2010 Available for comment March 24-May 7, 2010 Medical Policy Group, June 2010 (3) Medical Policy Administration Committee, July 2010 Medical Policy Group, July 2010 (3) Medical Policy Administration Committee, August 2010 Available for comment August 6-September 18, 2010 Medical Review Group, March 2011 (3) Medical Policy Administration Committee, March 2011 Available for comment April 4 May 18, 2011 Medical Policy Group, July 2011; Update to Benefit Application Section Monsanto Grp Medical Policy Group, April 2012 (3): Updated Policy to add oral devices (Provent), Key Points, Approved by Governing Bodies, & References Medical Policy Administration Committee; May 2012 Available for comment May 10 through June 25, 2012 Medical Policy Group, May 2012 (3): Updated Key Points and References Page 41 of 42

42 Medical Policy Group, May 2012 (3): Added information regarding non-coverage of the Winx System, Oral Pressure Therapy (by ApniCure) Available for comment June 14 through July 30, 2012 Medical Policy Panel, May 2013 Medical Policy Group, May 2013 (3): 2013 Updates no new literature available for review through April 17, 2013; no changes in policy statement Medical Policy Group, December 2013 (5): 2014 Coding Update added new code A7047 to current coding effective 01/01/2014. Medical Policy Group, April 2014 (5): Updated Maximums for CPAP tubing; Policy section reworked and organized to include Medical and Surgical management of OSA under new effective date. Medical Policy Administration Committee May 2014 Available for comment May 6 through June 19, 2014 Medical Policy Panel, May 2014 Medical Policy Group, June 2014(5): Updated Policy statement adding investigational statement for hypoglossal nerve stimulation; Key word, Key Points, Approved by Governing Bodies, & References updated with literature review through April 25, Medical Policy Administration Committee June 2014 Available for comment June 19 through August 2, 2014 Medical Policy Group, July 2014(5): Updated policy statement to included RERA(respiratory event- related arousals) in the definition of RDI; Rearranged and added information under description and added reference July Medical Policy Administration Committee, July Medical Policy Panel November 2014 Medical Policy Group, November 2014 (5): Updated key points and references per literature review; no change in policy statement. Medical Policy Panel, May 2015 Medical Policy Group, May 2015 (6): Updates to Description, Key Points, Approved by Governing Bodies, Key Words and References; no change to policy statement. Medical Policy Group, October 2015 (6): Clarification to Policy section Related Supply Coverage, A4604 and A7037 covered for a combined max of 1 per 120 days. Added new Key Word (hypoglossal nerve stimulation) Medical Policy Panel, November 2015 Medical Policy Group, December 2015 (6): Updates to Description, Key Points and References; no change in policy statement. This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a caseby-case basis according to the terms of the member s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield s administration of plan contracts. Page 42 of 42