Humana Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments Form

Description

Obstructive sleep apnea (OSA) is a common sleep disorder in which the muscles of the soft palate and throat intermittently relax during sleep, creating an obstruction that blocks the upper airway. This causes breathing to become difficult and noisy (snoring). Individuals with OSA experience apnea (cessation of breathing) from 10 to 60 seconds at a time, which can occur up to 120 times an hour during sleep. As a result, oxygen levels in the bloodstream decrease, which may lead to abnormal heart rhythms, heart attack, high blood pressure and/or stroke.

Central sleep apnea (CSA) is a disorder characterized by repetitive cessation or decrease of both airflow and ventilatory effort during sleep. It can be primary (idiopathic CSA) or secondary. Examples of secondary CSA include CSA associated with Cheyne-Stokes breathing, a medical condition, a drug or substance or high altitude periodic breathing. CSA associated with Cheyne-Stokes breathing is particularly common, especially among individuals who have heart failure or have had a stroke.

Upper airway resistance (UAR) syndrome is a type of sleep-disordered breathing involving increased airflow obstruction causing the individual to wake frequently, which can cause fatigue; however, UAR does not typically cause a decrease in oxygen saturation as does OSA.

Surgical treatments for OSA and other sleep related breathing disorders include, but may not be limited to, the following:

• Cautery-assisted palatal stiffening operation (CAPSO) is an office-based procedure, performed under local anesthesia, for the treatment of palatal snoring in which a portion of the soft palate is removed. (Refer to Coverage Limitations section)
• Drug induced sleep endoscopy (DISE) is a diagnostic test that is done under sedation, usually in an operating room and evaluates the severity of airway blockage related to concentric collapse. If an individual has complete concentric collapse in their airway, both the soft palate (soft part of the roof of the mouth) and sides of the throat completely block the airway. Individuals with complete concentric collapse are not candidates for hypoglossal nerve stimulation.
• Genioplasty (mentoplasty) is surgery of the chin where a receding chin is altered with an implant or a prominent chin is reduced. (Refer to Coverage Limitations section)
• Hyoid myotomy and suspension is a surgical procedure where an incision is created in the neck and the hyoid bone, which is connected to the tongue base and epiglottis, is advanced and secured in order to stabilize the airway. This may be performed in combination with genioglossus advancement, a surgical procedure where the base of the tongue is pulled forward to increase the airway size.

[UAS] System) utilizes an implantable pulse generator, a respiratory-sensing lead and a stimulating lead surgically placed on the hypoglossal nerve.

Mild electrical stimulation to the hypoglossal nerve produces selective motor stimulation of the muscle fibers that draw the tongue forward via activation of the genioglossus muscle, which improves upper airway obstruction. The individual uses a remote control to turn the device on before going to sleep and turn it off upon awakening. HGNS is intended to be a lifelong therapy.

• Injection snoreplasty is a procedure suggested for the treatment of snoring (not sleep disorders). It involves the injection of a hardening agent into the lining of the palate at the base of the uvula resulting in palatal stiffness, which purportedly reduces palatal flutter or primary snoring. (Refer to Coverage Limitations section)
• Laser-assisted uvulopalatoplasty (LAUP) removes a portion of the soft palate and uvula with laser ablation to enlarge the naso-oropharyngeal opening. The laser technique reportedly allows surgeons to perform the procedure under local anesthesia on an outpatient basis. (Refer to Coverage Limitations section)
• Nasal surgery of the turbinates (eg, turbinectomy, laser cautery, electrocautery, cryotherapy or submucosal resection) for symptomatic nasal obstruction or turbinate hypertrophy is performed to supposedly reduce the size of the turbinates to decrease airway resistance, while preserving the natural function, which is to clean and humidify the air as it moves through the nose. (Refer to Coverage Limitations section)
• Palatal implants (eg, Pillar Procedure) are intended to stiffen the structure of the soft palate. Three implants are inserted high up into the soft palate tissue under local anesthesia. The intended result is to change the airflow characteristics of the soft palate by stiffening and cause a reduction in airflow obstruction. (Refer to Coverage Limitations section)
• Phrenic nerve stimulation (PNS) for moderate to severe CSA uses an implantable device (eg, remede System) that purportedly delivers unilateral transvenous stimulation to deliver diaphragmatic contraction that mimics normal breathing patterns. This approach is believed to help restore normal breathing patterns by stimulating the phrenic nerve, which innervates the diaphragm, allowing better oxygenation and improving sleep. (Refer to Coverage Limitations section)
• Radiofrequency volumetric tissue reduction (RFVTR), also referred to as coblation, somnoplasty or submucosal ablation, is a surgical technique that utilizes radiofrequency ablation to produce finely controlled necrotic lesions to tissues of the soft palate, tongue, tonsils and turbinates. The necrosis purportedly leads to the formation of scar tissue, which upon healing should shrink and tighten, thereby reducing snoring and OSA. (Refer to Coverage Limitations section)
• Septoplasty is the surgical correction of defects and deformities of the nasal septum (the partition between the nostrils). (Refer to Coverage Limitations section)
• Tongue base suspension procedure (eg, AIRvance Tongue Suspension System, Encore Tongue Suspension System) suspends and repositions the tongue’s anterior base and the hyoid bone to the mandible bone using bone screws and suspension sutures purportedly relieving upper airway obstruction. (Refer to Coverage Limitations section)

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments

Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0419-031
Page: 4 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Commentary on Tonsillectomy

Tonsillectomy can reduce upper airway obstruction, especially in children. Tonsillectomy is the surgical removal of the tonsils, which are a collection of lymphoid tissue covered by mucous membranes located on either side of the throat.

An adenoidectomy is the surgical removal of the adenoid glands, which are masses of lymphoid tissue located at the back of the nose in the upper part of the throat. (Refer to Coverage Limitations section for adenoidectomy as a stand-alone treatment for individuals 17 years of age or younger)

• Tracheostomy is a surgical procedure in which an opening is created through the neck into the trachea (windpipe) and a tube placed through this opening to provide an airway.
• Transpalatal advancement pharyngoplasty is a procedure that was designed to surgically treat OSA in individuals that have narrowing in the retropalatal airway. Purportedly, the hard palate is excised and the soft palate is advanced anteriorly, which supposedly increases the retropalatal size and decreases retropalatal collapsibility. (Refer to Coverage Limitations section)
• Uvulectomy is the surgical removal of the uvula. It may be performed as part of an uvulopalatopharyngoplasty (UPPP) if the uvula is enlarged in individuals diagnosed with OSA. (Refer to Coverage Limitations section)
• Uvulopalatopharyngoplasty (UPPP) is the surgical revision of the posterior soft palate and adjacent tissue to relieve partial obstruction of the nasopharyngeal airway that causes OSA. Many surgeons perform this technique, but some perform a modification of it called an expansion sphincteroplasty, or expansion sphincter pharyngoplasty (ESP). This technique stiffens the lateral pharyngeal walls and prevents its collapse in patients with OSA. While UPPP involves removal of the uvula, most surgeons performing the modified version preserve the majority if not the entire uvula.

For information regarding other evaluation methods and treatments for obstructive sleep apnea and other sleep related breathing disorders not addressed in this policy, please see the following Medical Coverage Policies:

• Evaluation Method and/or Treatments: Orthognathic Surgery - Corresponding Medical Coverage Policy: Orthognathic Surgery
• Evaluation Method and/or Treatments: PAP Therapy and Other - Corresponding Medical Coverage Policy: Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments
• Evaluation Method and/or Treatments: Sleep Studies - Corresponding Medical Coverage Policy: Sleep Studies, Adult

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments

Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0419-031
Page: 5 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Eligibility Criteria for Surgical Treatments

Humana members 17 years of age or younger may be eligible under the Plan for genioglossal advancement, hyoid myotomy and suspension (with or without genioglossal advancement), UPPP or expansion sphincteroplasty when the following criteria are met:

• Confirmed diagnosis of moderate to severe OSA (AHI greater than or equal to 5); AND
• OSA symptoms are persistent following a tonsillectomy/adenoidectomy

Humana members 17 years of age or younger may be eligible under the Plan for tracheostomy when the following criteria are met:

• Confirmed diagnosis of severe OSA (AHI greater than 10); AND
• Persistent OSA despite other attempted medical or surgical treatments with no other options available

Humana members 13 to 18 years of age with Down Syndrome may be eligible under the Plan for a US Food & Drug Administration (FDA)-approved implantable upper airway hypoglossal nerve stimulation (HGNS) device (eg, Inspire Upper Airway Stimulation System) when ALL of the following criteria are met:

• Absence of any contraindications; AND
• Absence of complete concentric collapse at the soft palate level found during drug induced sleep endoscopy; AND
• AHI on polysomnogram (PSG) performed within 24 months of first consultation for the HGNS implant demonstrates 10 to 50 events per hour with less than 25% central apneas and mixed apneas; AND
• Body mass index (BMI) less than 95th percentile for individual’s age and gender per CDC growth charts; AND

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments

Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0419-031
Page: 7 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Contraindication to or not effectively treated by adenotonsillectomy; AND
• PAP failure or intolerance* despite efforts to increase compliance

Humana members may be eligible for replacement or removal of an FDA-approved implantable upper airway HGNS device, generator battery, leads and/or remote when a previously implanted device, generator battery, leads and/or remote is no longer functioning appropriately and the device is no longer under warranty.

Humana members may be eligible under the Plan for a drug induced sleep endoscopy (DISE) to determine whether HGNS would be appropriate.

Adults

Humana members 18 years of age or older may be eligible under the Plan for genioglossal advancement, hyoid myotomy and suspension (with or without genioglossal advancement), tonsillectomy/adenoidectomy, UPPP or expansion sphincteroplasty when the following criteria are met:

• Confirmed diagnosis of OSA (AHI greater than 15); AND
• Documented positive airway pressure (PAP) therapy failure or intolerance*

Humana members 18 years of age or older may be eligible under the Plan for tracheostomy when the following criteria are met:

• Confirmed diagnosis of OSA (AHI greater than 15); AND
• Persistent OSA despite other attempted medical or surgical treatments with no other options available

Humana members 18 years of age or older may be eligible under the Plan for a US Food & Drug Administration (FDA) approved implantable upper airway hypoglossal nerve stimulation (HGNS) device (eg, Inspire Upper Airway Stimulation System) when ALL of the following criteria are met:

• Absence of any contraindications; AND
• Absence of complete concentric collapse at the soft palate level found during drug induced sleep endoscopy; AND
• AHI on polysomnogram (PSG) performed within 24 months of first consultation for the HGNS implant demonstrates 15 to 100 events per hour with less than 25% central and mixed apneas; AND
• Body mass index (BMI) less than or equal to 40; AND
• Documentation that demonstrates PAP therapy compliance (greater than 4 hours per night, 5 nights per week for a minimum of 1 month) and subsequent failure defined as:
  • Inability to eliminate OSA (AHI greater than 15) with consistent use of the device; OR
  • PAP failure or intolerance* despite efforts to increase compliance

Humana members may be eligible for replacement or removal of an FDA-approved implantable upper airway HGNS device, generator battery, leads and/or remote when a previously implanted device, generator battery, leads and/or remote is no longer functioning appropriately and the device is no longer under warranty.

Humana members may be eligible under the Plan for a drug induced sleep endoscopy (DISE) to determine whether HGNS would be appropriate.

PAP failure or intolerance may be demonstrated by the following:

• Abnormal nasal, sinus or palatal structures (eg, deviated septum, swollen turbinates, high arching upper palate); OR
• Continued apneas, despite compliance (greater than 4 hours per night, 5 nights per week for a minimum of 1 month) with prescribed therapy and equipment adjustments including mask and/or pressure settings if medically appropriate;

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Excessive daytime sleepiness or level of sleepiness as measured by sleep measurement scale (eg, Epworth Sleepiness Scale, Psychomotor Vigilance Task, Stanford Sleepiness Scale); OR
• Frequent awakenings (eg, greater than or equal to 5 times in a night); OR
• Inability to tolerate the sensation of pressure or noise from the PAP device or a sense of claustrophobia; OR
• Persistent nasal or upper airway dryness or congestion; OR
• Snoring or choking episodes during sleep

Coverage Limitations

Humana members may NOT be eligible under the Plan for OSA surgical treatments for any indications or procedures other than those listed above. This includes, but may not be limited to, the following:

• Adenoidectomy as a stand-alone treatment (without tonsillectomy) for OSA in individuals 17 years of age or younger; OR
• Cautery assisted palatal stiffening operation (CAPSO); OR
• Genioplasty (mentoplasty); OR
• Injection snoreplasty; OR
• Laser assisted uvulopalatoplasty (LAUP); OR
• Nasal turbinate resection; OR
• Palatal implants (eg, Pillar Procedure); OR
• Radiofrequency volumetric tissue reduction (RFVTR); OR
• Septoplasty; OR

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0419-031
Page: 10 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Tongue based suspension procedure (eg, AIRvance or Encore Tongue Suspension Systems); OR
• Transpalatal advancement pharyngoplasty; OR
• Uvulectomy as stand-alone treatment for OSA

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for hypoglossal nerve stimulation (HGNS) (eg, Inspire Upper Airway Stimulation System) for any indications other than those listed above or for the following contraindications:

• 17 years of age or younger (unless the individual meets pediatric criteria for HGNS); OR
• Any anatomical finding that would compromise the performance of upper airway stimulation (presence of complete concentric collapse of the soft palate, tonsil size 3+ or 4+); OR
• Any condition or procedure that has compromised neurological control of the upper airway; OR
• Central and mixed apneas greater than 25% of the AHI; OR
• Individual who is pregnant or plans to become pregnant; OR
• Individual who is unable or does not have the necessary assistance to operate the sleep remote; OR
• Individual with a condition that requires or is likely to require future magnetic resonance imaging (MRI) (unless the HGNS device is MRI-compatible); OR

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0419-031
Page: 11 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Individual with an already implanted device that may be susceptible to unintended interaction with the system

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for drug induced sleep endoscopy (DISE) for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for central sleep apnea (CSA) surgical treatments including, but may not be limited to, phrenic nerve stimulation (eg, remede System). These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the surgical treatments of upper airway resistance syndrome (UARS). These are considered experimental/ investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about OSA and other sleep related breathing disorders may be found from the following websites:

• Background
• American Academy of Otolaryngology-Head and Neck Surgery
• American Academy of Sleep Medicine
• American Sleep Apnea Association
• National Library of Medicine

Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Surgical Treatments Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0419-031 Page: 12 of 27

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Medical Alternatives

Alternatives to OSA and other sleep related breathing disorders surgical treatments include, but may not be limited to, the following:

• Abstinence from alcohol and hypnotic sedatives, especially at bedtime
• Oral appliances** (please refer to Obstructive Sleep Apnea and Other Sleep Related Breathing Disorders Nonsurgical Treatments Medical Coverage Policy)
• Weight reduction

Physician consultation is advised to make an informed decision based on an individual’s health needs. **Upper airway surgery may supersede the use of oral appliances in individuals for whom these operations are predicted to be highly effective in treating OSA.

Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.