Point32 Surgical Procedures for the Treatment of Obstructive Sleep Apnea(Eff. beginning 1.1.24) Form

Obstructive sleep apnea (OSA)

Obstructive sleep apnea (OSA), the most common form of sleep apnea, is the collapse of the upper airway leading to the reduction or cessation of airflow during sleep. Oral surgeries are used to treat obstructive sleep apnea (OSA) by opening airways or removing obstructions.

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth

for coverage determinations for its Dual Product Eligible plan members. CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) and documentation included in the Medicare manuals and MassHealth Medical Necessity Determinations are the basis for coverage determinations.

For Tufts Health One Care plan members

the following criteria is used for the services of maxillomandibular Advancement (MMA)/ Mandibular Advancement (MA), Genioglossus Advancement (GA)/Hyoid Suspension, and uvulopalatopharyngoplasty (UPPP):

• LCD - Surgical Treatment of Obstructive Sleep Apnea (OSA) (L34526) (cms.gov)
• Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea LCD L38528 is being supplemented to provide additional detail regarding medical necessity criteria for its Dual Product Eligible plan members.

For the service of Surgical Treatment for Obstructive Sleep Apnea (OSA), evidence is sufficient for coverage. The criteria used for hypoglossal nerve stimulator below is based upon the Stimulation Treatment for Apnea Reduction (STAR) study and provides additional guidance for Members with OSA.

The use of this criteria in the utilization management process will ensure access to evidence based clinically appropriate care. See References section below for all evidence accessed in the development of these criteria.

Clinical Guideline Coverage Criteria

The Plan requires the use of the following InterQual^® Subsets or SmartSheets to obtain prior authorization for Uvuloplatopharyngoplasty.

1. Uvuloplatopharyngoplasty (UPPP)

In addition, The Plan requires the following criteria for:

1. Maxillomandibular advancement (MMA)/ Mandibular Advancement (MA)
2. Genioglossus Advancement/ Hyoid Suspension
3. Hypoglossal Nerve Stimulation.

General Eligibility Criteria for Maxillomandibular Advancement, Mandibular Advancement, Genioglossus Advancement, and Hyoid Suspension:

The Plan considers Maxillomandibular Advancement, Mandibular Advancement, Genioglossus Advancement and Hyoid Suspension as medically necessary when ALL of the following General Eligibility criteria are met:

1. Polysomnography or home sleep study confirms one of the following:
   • Diagnosis of moderate to severe OSA (AHI/RDI > 15), or;
   • Symptomatic mild OSA (AHI/RDI 5-14) with ANY of the following:
     1. Epworth Sleepiness Scale score > 9
     2. Excessive daytime sleepiness
     3. Mood Disorder
     4. Insomnia
     5. Hypertension
     6. History of Stroke
2. Medical record includes evidence of the failure of prior medical treatment for OSA:
   • Documentation from a sleep specialist certified by an approved specialty board of the American Board of Medical Specialties (e.g., ABIM), that the member has had a previous trial of positive airway pressure (PAP) device that failed or was not tolerated for the ONE or more of the following:
     1. Significant clinical improvement was not demonstrated with a trial of PAP; or
     2. The device trialed could not be tolerated because of claustrophobia, inability to breathe through nose, pain or increasing levels of discomfort; or
     3. Documentation of continued complaint of pressure discomfort which precludes proper use of CPAP and is unable to be resolved (e.g., pressure and interface adjustments); and
     4. Attempts to resolve reason(s) for PAP failure/intolerance, including but not limited to poor mask fit, excessive leak, adjustments in humidification and improper treatment settings, have failed

Member has been informed of the use of an oral appliance as an alternative to surgery for treatment of OSA

Service Specific Criteria

• Surgical Procedure Maxillomandibular Advancement (MMA)
• Procedures are authorized as follows: Documentation confirms member meets the general eligibility criteria;
• Surgical retronasal Mandibular Advancement (MA) procedures performed to correct or improve hypopharyngeal obstruction by moving the jaw(s) and base of the tongue to increase the size of the posterior airway space.
• The Plan may cover when documentation* confirms craniofacial skeletal abnormalities for which correction of those abnormalities is expected to significantly improve OSA; OR
• *Required documentation includes lateral cephalometric radiographs with tracings, measurements and predictions, or 3D CT scan of the upper airway when requested for a member whose OSA failed to improve sufficiently following other surgical procedures for OSA (Confirmation by polysomnography or home sleep study within the past year is required).

Hypoglossal Nerve Stimulation
The Plan may cover hypoglossal nerve stimulation implantation procedures when ALL of the following criteria are met:

1. Member is 22 years of age or older; and
2. Body Mass Index (BMI) is less than 32 kg/m²; and
3. A polysomnography (PSG) performed no more than 24 months prior to the consultation for HGNS implant confirms:
   • Moderate to severe obstructive sleep apnea (OSA) with apnea hypopnea index (AHI) is 15 to 65 events per hour; and
   • Predominantly obstructive events, defined as central and mixed apneas less than 25 percent of the total AHI
4. Member has trialed continuous PAP (CPAP) and/or bi-level PAP within the previous 24 months and for a minimum of three months, AND documented failure and/or intolerance to CPAP and/or bi-level PAP is confirmed by the following:
   • Continued AHI greater than 15 despite compliant use of CPAP and/or bi-level PAP 4 or more hours per night, 5 or more nights per week; and/or
   • Inability to tolerate CPAP and/or bi-level PAP a minimum of four or more hours per night, five or more nights per week; and
   • Failure of and/or intolerance to CPAP/bi-level PAP despite consultation with a sleep expert:
     1. Attempts to resolve reason(s) for failure/intolerance, including but not limited to poor mask fit, excessive leak, adjustments in humidification and improper treatment settings; and
     2. Alternative non-invasive treatments for treatment of OSA, after failure or intolerance of CPAP and/or bi-level PAP, were considered and these non-invasive treatments failed or were deemed inappropriate. Alternative non-invasive treatments include but are not limited to oral appliance therapy, positional therapy and/or weight loss
5. Surgical consultation indicating absence of complete concentric collapse at the soft palate level as seen on a drug induced sleep endoscopy (DISE) procedure; and
6. DISE procedure identifies no anatomical findings that would compromise performance of device (e.g., tonsil size three or four per standardization tonsillar hypertrophy grading scale)*

Note: Facility PAP titration study and unattended auto-titration of PAP (APAP) do not qualify as required 3-month trial of CPAP/bi-level PAP device* Individuals with certain Inspire stimulator models may not be eligible for MRI scans.

Refer to MRI guidelines for Inspire Therapy manual: manuals.inspiresleep.com

NOTE: Refer to the following Medical Necessity Guidelines for treatment of disorders not related to Obstructive Sleep Apnea

• Orthognathic Surgery for Severe Oral-Maxillofacial Functional Disorders
• Temporomandibular Joint (TMJ) Disorder Treatment

Limitations

The Plan does not cover the following procedures:

1. Tongue base suspension, permanent suture technique, e.g., AIRvance Bone Screw System; CPT code 41512
2. Repose System
3. Laser-Assisted Uvulo-Palatoplasty (LAUP) - CPT code S2080
4. Pillar Palatal Implant System - C9727
5. Reduction of Base of Tongue (RBOT)
6. Somnoplasty of the soft palate - CPT unlisted code 42299
7. Transoral robotic surgery
8. Surgical treatment for snoring alone
9. Uvulectomy
10. Laser assisted Uvulopalatoplasty (UPP)
11. Submucosal ablation of the tongue base; CPT code 41530
12. Facility PAP titration study and unattended auto-titration of PAP (APAP) do not qualify as a trial of PAP
13. Implantation of non-FDA approved hypoglossal nerve neurostimulation device
14. Implantation of HGNS device for indications other than above
15. The Plan will not cover the HGNS implantation when:
    • Member is with presence of any of the following:
    • BMI 32 or greater kg/m²
    • Neuromuscular disease affecting the respiratory system
    • Hypoglossal-nerve palsy
    • Severe restrictive or obstructive pulmonary disease
    • Moderate to severe pulmonary arterial hypertension
    • Severe valvular heart disease
    • NYHA class III or IV heart failure
    • Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months)
    • Persistent uncontrolled hypertension despite medication use
    • An active, serious mental illness that reduces the ability to carry out Activities of Daily Living (ADLs) and would interfere with the patient’s ability to operate the HNS and report problems to the attending provider
    • Coexisting non-respiratory sleep disorders that would confound functional sleep assessment
    • Members with any condition or procedure that has compromised neurological control of the upper airway
16. Member is unable or does not have the necessary assistance to operate the sleep remote
17. Member is, or is planning to become pregnant

Surgical Procedures for the Treatment of Obstructive Sleep Apnea

Codes