This policy version was replaced on August 2, 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).

The hypoglossal nerve (cranial nerve XII) innervates the genioglossus muscle. Stimulation of the nerve causes anterior movement and stiffening of the tongue and dilation of the pharynx. Hypoglossal nerve stimulation reduces airway collapsibility and alleviates obstruction at both the level of the soft palate and tongue base. 

Hypoglossal nerve stimulation uses an implantable pacemaker-like device capable of stimulating the nerve strongly enough to evoke a response keeping the airway open, but without disturbing sleep. Patients control therapy start and stop times with a handheld controller. The pulse generator processes information from the sensor and determines the most beneficial time in the breathing cycle to deliver the stimulation. The single lead pressure sensor provides real-time breathing cycle data throughout the night.

In May 2014, the FDA granted premarket approval (PMA) to the Inspire® II Upper Airway Stimulation System. The device is intended to treat a subset of patients with moderate to severe OSA. In June 2017, the FDA granted approval to expand the Apnea Hypopnea Index range from 20 to 65, to 15 to 65 events per hour.

Definitions

Tonsillar hypertrophy grading scale:

• 0: tonsils are entirely within the tonsillar fossa;
• 1+: tonsils occupy less than 25% of the lateral dimension of the oropharynx as measured between the anterior tonsillar pillars; 
• 2+: tonsils occupy less than 50 percent of the lateral dimension of the oropharynx;
• 3+: tonsils occupy less than 75 percent of the lateral dimension of the oropharynx;
• 4+: tonsils occupy 75 percent or more of the lateral dimension of the oropharynx.  

Note: For other treatments of obstructive sleep apnea, please see medical policy IV-07, Treatment of Obstructive Sleep Apnea and Snoring in Adults.

I.    Hypoglossal nerve stimulation may be considered MEDICALLY NECESSARY AND APPROPRIATE in adults with obstructive sleep apnea when ALL of the following criteria are met: 

• Age ≥ 22 years; AND
• Body mass index (BMI) ≤ 32 kg/m²; AND
• Apnea/hypopnea index (AHI), respiratory disturbance index (RDI), or respiratory event index (REI) ≥ 15 with less than 25% central apneas; AND 
• Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), including documentation that the patient was intolerant of PAP for a minimum of 12 weeks, despite multiple models of facial masks and nasal pillows, and consultation with a sleep specialist; AND
• Absence of the following:
  • Complete concentric collapse at the soft palate level;
  • Severe or restricted obstructive pulmonary disease;
  • Neuromuscular disease affecting the respiratory tract;
  • Severe valvular heart disease;
  • Pregnancy or planned pregnancy;
  • Any other anatomical findings that would compromise performance of the device (e.g., tonsil size 3 or 4 per tonsillar hypertrophy grading scale).

II.   Hypoglossal nerve stimulation may be considered MEDICALLY NECESSARY AND APPROPRIATE in adolescents or young adults with Down syndrome and obstructive sleep apnea syndrome (OSA) when ALL of the following criteria are met:

• Age 10 to 21 years; AND
• Body mass index ≤ 95th percentile for age; AND
• AHI >10 and <50 with less than 25% central apneas after prior adenotonsillectomy; AND
• Have either tracheotomy or ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device; AND
• Non-concentric retropalatal obstruction on drug-induced sleep endoscopy.

III.  All other uses of hypoglossal nerve stimulation are considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

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:

1. Sleep study confirming diagnosis of sleep apnea must show moderate to severe OSA, performed within the previous year;
2. A summary of all conservative OSA treatments attempted, including length of trial and results;
3. Results of drug-induced sleep endoscopy procedure.