Health First Hypoglossal Nerve Stimulation Implant (Inspire TM ) Form

Hypoglossal Nerve Stimulation

may be considered medically necessary when the clinical criteria described in this Policy are met.

Definitions:

Apnea-Hypopnea Index (AHI):

A scale that measures the average number of apneas and hypopneas an individual has during each hour of sleep. The index identifies OSA severity.

Hypoglossal Nerve Stimulation (HGNS):

The only Food and Drug Administration (FDA) approved device (Inspire TM) has three implantable components:

1. A stimulation lead that delivers mild stimulation to maintain multilevel airway patency during sleep
2. A breathing sensor lead that senses breathing patterns
3. A generator that monitors breathing patterns

The two external components are a patient sleep remote that provides a noninvasive means for a patient to activate the generator and a physician programmer that allows the physician to noninvasively interrogate and configure the generator settings. The system battery life for the implantable components is 7 to 10 years.

Obstructive Sleep Apnea (OSA):

Characterized by episodes of complete collapse of the airway or partial collapse with an associated decrease in oxygen saturation or arousal from sleep. This disturbance results in fragmented, nonrestorative sleep. Obstructive sleep apnea is classified by severity.

1. Severe obstructive sleep apnea means that your AHI is greater than 30 (more than 30 episodes per hour)
2. Moderate obstructive sleep apnea means that your AHI is between 15 and 30.
3. Mild obstructive sleep apnea means that your AHI is between 5 and 15.

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Description:

Obstructive sleep apnea (OSA) is a disease characterized by recurrent episodes of upper airway obstruction during sleep. The disruption in airflow caused by OSA has been associated with multiple comorbidities, including hypertension, cardiovascular disease, cardiac arrhythmia, cerebrovascular disease, excessive daytime sleepiness, and mood disorders. Continuous positive airway pressure (CPAP) has long been the primary treatment modality of choice for OSA, showing improvements in many comorbidities. Unfortunately, despite attempts to improve compliance, many people are unable to tolerate treatment with CPAP. A large percentage of patients do not tolerate CPAP, requiring alternative treatment strategies.

The implantable Hypoglossal Nerve Stimulator is used to treat OSA. The stimulator is an implanted medical device that reduces the occurrence of OSA by electrically stimulating the hypoglossal nerve, which causes tongue movement. This stimulation is timed with breathing to relieve upper airway obstruction. The device that generates electrical impulses through a generator is implanted in the upper right chest (under the skin). The impulse is transmitted via a tunneled lead that ends up with a cuff that surrounds the hypoglossal nerve.

The hypoglossal nerve is the twelfth cranial nerve and innervates all the extrinsic and intrinsic muscles of the tongue, except for the palatoglossus which is innervated by the vagus nerve. The nerve arises from the hypoglossal nucleus in the brain stem as a number of small rootlets, passes through the hypoglossal canal and down through the neck, and eventually passes up again over the tongue muscles it supplies into the tongue. There are two hypoglossal nerves in the body: one on the left, and one on the right.

A surgeon implants the system containing a neurostimulator subcutaneously in the patient's chest, with one lead attached to the patient's hypoglossal nerve (cranial nerve XII) at the base of the tongue and one lead implanted in the patient's chest. The lead in the chest consists of a pressure sensor that detects breathing. Information about respiration rate is relayed to the device, which stimulates the hypoglossal nerve in the tongue. When stimulated, the tongue moves forward, opening the airway. The patient can operate the device by remote control, which the patient activates before going to sleep. The device turns on after 20 minutes to minimize disrupting the patient's sleep onset; the device must be manually turned off via remote when the patient wakes.

Clinical Criteria: (Indications/Limitations)

1. FDA-approved hypoglossal nerve neurostimulation is considered medically necessary for the treatment of moderate to severe obstructive sleep apnea when all the following criteria are met:

A. Member is 22 years of age or older; and
B. Body mass index (BMI) is less than 32 kg/m2; and
C. A polysomnography (PSG) is performed within 24 months of first consultation for HGNS implant; and
D. Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total AHI); and
E. AHI is 15 to 65 events per hour; and
F. Beneficiary has documentation that demonstrates CPAP failure (defined as AHI greater than 15 despite CPAP usage) or CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or the CPAP has been returned) including shared decision making that the patient was intolerant of CPAP despite consultation with a sleep expert; and
G. Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep endoscopy (DISE) procedure; and
H. No other anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale).

2. Hypoglossal nerve stimulation for the treatment of OSA must be ordered and furnished by qualified personnel.

A. Provider Specialties

i. Insertion of hypoglossal nerve stimulation must be performed by a qualified physician (MD or DO) who is a board certified, or a board eligible otolaryngologist having completed a residency and/or fellowship program and maintains ongoing certification in otolaryngology.

ii. Insertion of an FDA-approved hypoglossal nerve stimulation device must be performed by a qualified physician who completed the appropriate AMA or AOA certified residency program in otolaryngology.

iii.

In addition, prior to implanting the system, surgeons will need to receive classroom instruction by an FDA approved device manufacturer or equivalent on device implant techniques as well as cadaver training. Documentation must be provided upon request to support completion of training to an exemplary level by the manufacturer.

iv. Upon request, sleep physicians and sleep technicians will be able to document classroom instruction from a similar facility on how to titrate the device including hands on operation of the program.

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3. Limitations:

1. Hypoglossal nerve neurostimulation is considered not medically necessary for all other indications.
2. Non-FDA-approved hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for the treatment of adult obstructive sleep apnea due to insufficient evidence of safety and effectiveness.
3. Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary when any of the following contraindications are present:
   • Members with central and mixed apneas
   • Members with an implantable device could experience unintended interaction with the HGNS implant system.
   • BMI equal to or greater than 35
   • Neuromuscular disease
   • Hypoglossal-nerve palsy
   • Severe restrictive or obstructive pulmonary disease
   • Moderate-to-severe pulmonary arterial hypertension
   • Severe valvular heart disease
   • New York Heart Association 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 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 who are, or who plan to become pregnant.
   • Members who are unable, or do not have the necessary assistance, to operate the sleep remote.
   • Members with any condition or procedure that has compromised neurological control of the upper airway