This policy version was replaced on November 1, 2021. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Obstructive sleep apnea (OSA) results from repetitive pharyngeal narrowing or collapse during sleep. Known contributors to OSA (and snoring) include relaxation of the soft palate, posterior displacement of the base of the tongue, and collapse of the hypopharyngeal airway. Several medical and surgical treatments have been developed to correct these causative factors and relieve symptoms.

Medical Management

Lifestyle modification and weight management

Weight loss can lead to improvement of OSA-related symptoms and severity. As a result, weight management is a first line treatment of OSA. Lifestyle changes and modifications to sleep position are also first lines of OSA management. Lifestyle changes include avoidance of alcohol, sedatives and stimulants, especially before bedtime. Sleep position changes, such as sleeping on one's side rather than back, and using pillows or other supports to maintain a more optimal position during sleep can also improve OSA.

Intraoral appliances are available as "off the shelf" products or devices that are custom made for the patient by a qualified dental laboratory or similar provider. 

A qualified dental provider is trained and experienced in the overall care of oral health, the temporomandibular joint, dental occlusion and associated oral structures; and is a Doctor of Dental Surgery (DDS) or Doctor of Dental Medicine (DMD).

Positive airway pressure

• Continuous positive airway pressure (CPAP) involves the administration of air through the nose, by an external device at a fixed pressure to maintain the patency of the upper airway.  
• Bilevel Positive Airway Pressure (BiPAP) is similar to CPAP, but these devices are capable of generating two adjustable pressure levels.
• Auto-adjusting PAP (APAP or AutoPAP) adjusts the level of pressure based on the level of resistance. As a result, the device may administer a lower mean level of positive pressure during the night. APAP may also be used to initiate and titrate CPAP in adult patients with clinically significant OSA.

It has been hypothesized that both BiPAP and APAP are more comfortable for the patient, and thus might improve patient compliance or acceptance.

Surgical Treatment

When medical management fails, surgical treatment may be indicated. Multiple surgical procedures have been developed to address OSA or snoring.

Uvulopalatopharyngoplasty (UPPP) involves removing the uvula, a portion of the soft palate, and the palatine tonsils. The resulting scarring stiffens the soft palate, and is effective in reducing snoring, and to a lesser extent, relieving OSA. UPPP may be appropriate for patients with narrowing or collapse in the retropalatal (oropharyngeal) region.

Laser-assisted uvulopalatoplasty (LAUP) involves laser vaporization of the full length of the superficial layer of the soft palate on both sides of the uvula. The extent of surgery is typically different than standard UPPP since only part of the uvula and associated soft palate tissues are reshaped. The procedure is performed to alleviate snoring but has not been proven to be effective for treatment of obstructive sleep apnea.

Surgeries in patients with narrowing or collapse in the retrolingual (hypopharyngeal) area

For patients with narrowing or collapse in the retrolingual (hypopharyngeal) area, inferior sagittal mandibular osteotomy and genioglossal advancement with or without hyoid myotomy and suspension may be appropriate. The procedure creates an enlarged retrolingual airway. In this procedure, the area of anterior attachment of the tongue is advanced by performing a mandibular osteotomy. The released segment of bone is drawn anteriorly with the attached tendon of the genioglossus and is fixed into position on the mandible. In some cases, the hyoid bone is advanced and suspended from the mandible by a fascial strip. For patients with both retropalatal and retrolingual obstruction, UPPP and inferior sagittal mandibular osteotomy and genioglossal advancement with or without hyoid myotomy and suspension may be performed.

Mandibular-maxillary advancement (MMA) may be another option for patients with narrowing or collapse of the retrolingual (hypopharyngeal) area. MMA involves simultaneous advancement of the maxilla and mandible through sagittal-split osteotomies which provides maximal enlargement of the retrolingual airway and some advancement of the retropalatal airway.

Radiofrequency volumetric tissue reduction (RFVTR) is a 30-minute procedure involving thermal ablation of excessive tissue in the area of the uvula, soft palate, tongue base, and turbinates to reduce severe snoring. The Somnoplasty® device has been cleared for marketing by the FDA for radiofrequency ablation of palatal tissues for simple snoring and for the base of the tongue for OSA.

Tongue base suspension is intended to make it less likely for the base of the tongue to prolapse during sleep. 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. Airvance®, formerly the Repose™ Bone Screw System was cleared for marketing through the FDA 510(k) process for the treatment of OSA and/or snoring. The Encore™ Tongue Suspension System (Siesta Medical) has received clearance citing the PRELUDE III Tongue Suspension System as a predicate device.

Palatal implants have been proposed as a method for managing snoring and for the treatment of mild to moderate OSA. Palatal implants consist of narrow threads of braided polyethylene terephthalate which are slightly less than an inch in length. The cylindrical implants are inserted into the soft palate to increase the stiffness of the soft palate in order to reduce the vibrations. Two or three parallel implants are inserted in the soft palate using a special deployment device. The procedure is performed using local anesthetics. Scar tissue forms around the implants, further stiffening the palate. The implants are designed to be permanent, but they can be removed, if necessary. The Pillar™ Palatal Implant System is an implantable device that has been cleared for marketing through the FDA 510(l) process. 

Definitions

Apnea Hypopnea Index (AHI) equals the average number of episodes of apnea and/or hypopnea per hour of sleep.

• Apnea is defined as the cessation of airflow for at least 10 seconds.
• Hypopnea is defined as a reduction in airflow equal to or greater than 30% with an associated fall in oxygen saturation of at least 3% or the event is associated with arousal.

Central sleep apnea occurs when the brain temporarily stops sending signals to the muscles that control breathing. Central sleep apnea is not associated with obstruction, and is less common than obstructive sleep apnea. 

Mixed sleep apnea is apnea that combines elements of obstructive and central sleep apnea. 

Obesity Hypoventilation syndrome (OHS) may be defined as a combination of obesity, daytime hypoventilation, and sleep-disordered breathing in the absence of any alternative neuromuscular, mechanical, or metabolic explanation for hypoventilation. Patients with hypoventilation syndrome have a lower quality of life and are at risk for developing pulmonary hypertension and early mortality.

Obstructive sleep apnea (OSA): A diagnosis of OSA syndrome is accepted when an adult patient has an AHI greater than 5 and symptoms of excessive daytime sleepiness or hypertension. It is estimated that approximately 20% of adults have at least mild OSA, defined as an AHI or respiratory disturbance index (RDI) of 5-15 respiratory events per hour of sleep. In adults, an AHI or RDI equal to or greater than 15 is typically considered moderate OSA, while an AHI or RDI greater than 30 is considered severe OSA. An estimated 7% of adults have moderate or severe OSA.

Respiratory Disturbance Index (RDI): is defined as the number of apneas, hypopneas, and respiratory event related arousals (RERAs) per hour of sleep. It may be referred to along with or instead of AHI particularly in unattended sleep studies.

Upper Airway Resistance Syndrome (UARS) is characterized by a partial collapse of the airway resulting in increased resistance to airflow. UARS can occur in the absence of snoring and in patients who are not overweight. The resistance to airflow is typically subtle and does not result in apneas or hypopneas. It has been proposed that UARS is a distinct syndrome from OSA that may be considered a disease of arousal. In the absence of intrathoracic pressure monitoring, a positive response to continuous positive airway pressure (CPAP) has also been used to support the diagnosis.

Note: For hypoglossal nerve stimulation to treat obstructive sleep apnea, please see medical policy IV-80, Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea.

I.   Medical Management

• Intraoral Appliances
  • Intraoral appliances (e.g., mandibular advancing/positioning devices or tongue-retaining devices) may be considered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria are met:
    1. Patient has been diagnosed with OSA defined by :
       • An AHI or RDI of 15 or greater events per hour; OR
       • An AHI or RDI between 5 and 14 events per hour with any of the following associated symptoms:
         1. Excessive daytime sleepiness
         2. Documented hypertension
         3. Ischemic heart disease
         4. History of stroke; AND
    2. Central sleep apnea has been ruled out, as documented by a sleep study, AND
    3. There is  absence of temporomandibular dysfunction, periodontal disease, or gross dental decay; AND
    4. PAP therapy has not been effective despite a documented trial of at least one month; AND
    5. The device is prescribed after a face-to-face evaluation, and diagnosis of OSA has been established by a physician (MD or DO) who is either a diplomate of the American Board of Sleep Medicine, or a diplomate in a recognized subspecialty of the American Board of Medical Specialties (ABMS); AND
    6. The device is custom made by a qualified dentist, referred by one of the above specialties.
  • Prefabricated oral devices are considered NOT MEDICALLY NECESSARY.
• Continuous Positive Airway Pressure (CPAP)
  • Continuous positive airway pressure (CPAP) may be considered MEDICALLY NECESSARY AND APPROPRIATE in patients with confirmed OSA with:
    1. An AHI or RDI of 15 events per hour or greater; OR
    2. An AHI or RDI between 5 and 14 events per hour with any of the following associated symptoms:
       • Excessive daytime sleepiness
       • Documented hypertension
       • Ischemic heart disease
       • History of stroke
• Bi-level Positive Airway Pressure (BiPAP)
  • BiPAP may be considered MEDICALLY NECESSARY AND APPROPRIATE in patients who:
    1. Meet the criteria for CPAP; AND
    2. Have failed a prior trial of CPAP; OR
    3. For whom BiPAP is found to be more effective than CPAP in the sleep laboratory.
• Auto-Adjusting PAP (APAP)
  • APAP may be considered MEDICALLY NECESSARY AND APPROPRIATE in patients who:
    1. Meet the criteria for CPAP above; AND
    2. Have no evidence by history or physical examination of the following conditions:
       • Central sleep apnea
       • Congestive heart failure
       • Chronic pulmonary disease such as chronic obstructive pulmonary disease
       • Pulmonary hypertension
       • Obesity hypoventilation syndrome or other condition which may cause nocturnal arterial oxyhemoglobin desaturation

II.  Surgical Management

• Uvulopalatopharyngoplasty (UPPP)
  • UPPP may be considered MEDICALLY NECESSARY AND APPROPRIATE when all the following criteria are met:
    1. Presence of significant, unexplained cor pulmonale or cardiac arrhythmia resulting from documented OSA; OR
    2. An AHI or RDI of 15 events per hour or greater; AND
       • BMI less than 40; AND
       • A trial of oral appliance therapy has failed or the patient is not a candidate for an oral appliance; AND
       • Patient has not responded to or does not tolerate CPAP, BiPAP, or APAP following a minimum of 4 hours per night for three (3) months of PAP usage; OR
    3. An AHI or RDI between 5 and 14 and all of the following:
       • Documented hypertension, ischemic heart disease, or history of stroke; AND
       • BMI less than 40; AND
       • A trial of oral appliance therapy has failed or the patient is not a candidate for an oral appliance; AND
       • Patient has not responded to or does not tolerate CPAP, BiPAP, or APAP following a minimum of 4 hours per night for three (3) months of PAP usage.
• Maxillofacial Procedures
  • Maxillofacial surgical procedures, such as inferior sagittal mandibular osteotomy and genioglossal advancement with or without hyoid myotomy and suspension or mandibular-maxillary advancement (MMA) may be considered MEDICALLY NECESSARY AND APPROPRIATE when the following criteria are met:
    1. The patient has reached skeletal maturity; AND
    2. Presence of significant, unexplained cor pulmonale or cardiac arrhythmia resulting from documented OSA; OR
    3. An AHI or RDI of 15 events per hour or greater; AND
       • Objective evidence of hypopharyngeal obstruction documented by either fiberoptic examination or cephalometric radiographs; AND
       • Patient has not responded to or does not tolerate CPAP, BiPAP, or APAP following a minimum of 4 hours per night for three (3) months of PAP usage; OR
    4. An AHI or RDI between 5 and 14 and all of the following:
       • Documented hypertension, ischemic heart disease, or history of stroke; AND
       • Objective evidence of hypopharyngeal obstruction documented by either fiberoptic examination or cephalometric radiographs; AND
       • Patient has not responded to or does not tolerate CPAP, BiPAP, or APAP following a minimum of 4 hours per night for three (3) months of PAP usage.

III. Treatment of Snoring

• Treatment of snoring is considered NOT MEDICALLY NECESSARY AND APPROPRIATE because simple snoring in the absence of documented obstructive sleep apnea is not considered a medical condition. Therefore, all procedures for the sole or adjunctive treatment of snoring are considered NOT MEDICALLY NECESSARY AND APPROPRIATE, including but not limited to:
  • Uvulopalatopharyngoplasty (UPPP)
  • Uvulectomy
  • Laser-assisted uvulopalatoplasty (LAUP)
  • Radiofrequency volumetric tissue reduction of the palatal tissues
  • Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues
  • Palatal stiffening procedures, including but not limited to, cautery-assisted palatal stiffening operation, and the implantation of palatal implants
  • Tongue base suspension (e.g., Encore™, AIRvance™)

IV. Investigative Indications

• The following treatments are considered EXPERIMENTAL/INVESTIGATIVE due to a lack of evidence demonstrating improved health outcomes:
  • UPPP for any condition other than obstructive sleep apnea or snoring
  • Expiratory Positive Airway Pressure (EPAP) including the Provent® device
  • Oral pressure therapy devices, including but not limited to the Winx™ system
  • Atrial pacing
  • Oral devices (e.g., Morning Repositioner, ProSomnus) purported to prevent temporomandibular joint (TMJ) disorders
  • Palate and mandible expansion devices, including but not limited to, the Daytime Nighttime Appliance (DNA Appliance, Biomodeling Solutions) and the mandibular Repositioning Nighttime Appliance (mRNA Appliance Biomodeling Solutions)
  • Positional sleep therapy devices (e.g., NightBalance)
  • Biomimetic oral appliance therapy (BOAT)
  • All other surgical procedures for the sole or adjunctive treatment of obstructive sleep apnea/upper airway resistance syndrome, including but not limited to:
    1. Uvulectomy
    2. Laser-assisted uvulopalatoplasty (LAUP)
    3. Radiofrequency volumetric reduction of the palatal tissues
    4. Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues
    5. Palatal stiffening procedures including but not limited to, cautery-assisted palatal stiffening operation, and the implantation of palatal implants
    6. Tongue base suspension (e.g., Encore™, AIRvance™)

Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted with prior authorization requests for UPPP:

• A summary of the most recent sleep study including AHI or RDI; AND
• Clinical notes from within the previous 60 days describing:
  1. Comorbidities that may indicate medical necessity of UPPP if AHI or RDI equals 5 or more events per hour (i.e. cor pulmonale, cardiac arrhythmia) OR
  2. If AHI or RDI is between 5 and 14 events per hour information must include:
     • BMI; AND
     • Comorbidities (i.e., hypertension, ischemic heart disease or stroke); AND
     • A description of all trials of an oral appliance, CPAP, BiPAP, APAP or other noninvasive treatments including the length and results of the trials.

Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2019-10/X18509R07_Pre-Authorization%20Request%20Form.pdf