LCD L38528: Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea

Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.

Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.

History/Background and/or General Information

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. Because of the large percentage of patients not tolerating CPAP, alternative treatment strategies are necessary.

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. It is a nerve with a solely motor function. 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 branches within the tongue and innervates the tongue. There are 2 hypoglossal nerves in the body: 1 on the left, and 1 on the right.

The concept of stimulating the tongue musculature to increase upper airway size and limit the pathophysiologic obstruction leading to OSA was introduced in the late 1980s. A variety of strategies were utilized, including transcutaneous stimulation with placement of electrodes in the submental region, sublingual mucosa, and soft palate. However, these studies were limited by their lack of selective stimulation of the primary protrusor of the tongue, the genioglossus muscle. In 2001, Schwartz et al performed a trial in which they selectively stimulated the branches of the hypoglossal nerve, innervating the genioglossus. They noted a significant improvement in the apnea-hypopnea index (AHI) and O2 desaturation nadir. This technology was subsequently refined, and in 2014 the Stimulation Therapy for Apnea Reduction (STAR) trial was published as the initial clinical trial using upper airway stimulation (UAS) as an alternative therapy to CPAP for treatment of OSA.

The only Food and Drug Administration (FDA) - approved hypoglossal nerve stimulation (HGNS) system has 3 implantable components: a stimulation lead that delivers mild stimulation to maintain multilevel airway patency during sleep, a breathing sensor lead that senses breathing patterns, and a generator that monitors breathing patterns. The 2 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.

A surgeon implants the system containing a neurostimulator subcutaneously in the patient’s chest, with 1 lead attached to the patient’s hypoglossal nerve (cranial nerve XII) at the base of the tongue and 1 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.

Covered Indications

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

• Beneficiary is 22 years of age or older; and

• Body mass index (BMI) is less than 35 kg/m2; and

• A polysomnography (PSG) is performed within 24 months of first consultation for HGNS implant; and

• Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total AHI); and

• AHI is 15 to 65 events per hour; and

• 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

• Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep endoscopy (DISE) procedure; and

• No other anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale).

Limitations

The following are considered not reasonable and necessary and therefore will be denied:

• Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary for all other indications.

• 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 being safe and effective.

• Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary when any of the following contraindications are present:

• Beneficiaries with central and mixed apneas that make up more than one-quarter of the total AHI.

• Beneficiaries 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 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

• Beneficiaries who are, or who plan to become pregnant.

• Beneficiaries who require Magnetic Resonance Imaging (MRI) with model 3024.

• Beneficiaries, who require MRI with model 3028, can undergo MRI on the head and extremities if certain conditions and precautions are met. Please refer to the Manufacturer Guidelines for this model and future models for more information.

• Beneficiaries who are unable or do not have the necessary assistance to operate the sleep remote.

• Beneficiaries with any condition or procedure that has compromised neurological control of the upper airway.

• Drug Induced Sleep Endoscopy (DISE):

• Due to documented inconsistency in determining if complete concentric collapse (CCC) is present, the inserting provider shall be certified by the FDA approved manufacturer’s second opinion service of validation via video clip submissions of at least 80% agreement in at least 15 consecutive studies. Inserting providers shall have documentation to submit to this contractor if necessary.

• Shared Decision Making (SDM):

• SDM shall be documented in the patient’s record by the referring physician and the implanting physician. Both shall provide these documents if requested by this contractor.

Place of Service (POS)

Hypoglossal nerve stimulation for the treatment of OSA must be furnished in accordance with the accepted standards of medical practice in a setting appropriate to the patient’s medical needs and condition.

Provider Qualifications

Hypoglossal nerve stimulation for the treatment of OSA must be ordered and furnished by qualified personnel. The hypoglossal nerve (HN) may be damaged during neck surgeries. A detailed understanding of the anatomy of the hypoglossal nerve in relation to various anatomical landmarks and surrounding structures is important to reduce procedural complications and the risk of nerve damage.

• Provider Specialties

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

• 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. 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 to support completion of training to an exemplary level by the manufacturer. Sleep physicians and sleep technicians shall receive classroom instruction from a similar facility on how to titrate the device including hands on operation of the program. Doctors must maintain, for the contractor to review, documentation of such training completion to a satisfactory level of completion as established by the device manufacturer or appropriate board approval of competency. Evaluation, referral and post implant evaluation of the hypoglossal nerve stimulator but not including expected post-op care by the inserting physician, should be performed by board eligible or certified sleep physician with qualifications as outlined in LCD L36839, Polysomnography and Other Sleep Studies. Sleep Technicians shall meet the same qualifications as outlined in the LCD L36839, Polysomnography and Other Sleep Studies, in addition. Likewise, sleep studies shall be performed in an accredited sleep facility as stated in LCD L36839.

Notice: Services performed for any given diagnosis must meet all the indications and limitations stated in this policy, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements in this LCD.

Published Literature

STAR Trial 12-month follow-up:

Strollo, et al. for the STAR Trial Group evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. 1 The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean BMI was 28.4. Exclusion criteria were a BMI of more than 32.0, 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, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment. The study was designed by the sponsor (Inspire Medical Systems), the investigators, and the FDA as a multicenter, prospective, single-group trial with participants serving as their own controls. The primary outcome evaluation was followed by a randomized, controlled therapy-withdrawal study that included a subgroup of consecutive participants selected from the population that had a response to therapy. The primary outcome measures were assessed by means of overnight polysomnography and scored by an independent core laboratory with the use of standard criteria. The data analysis was performed by the independent statistician.

Participants underwent screening that included polysomnography, medical and surgical consultation, and endoscopy during drug-induced sleep. Participants were excluded if the AHI score from the screening polysomnography was less than 20 or more than 50 events per hour, if central or mixed sleep-disordered breathing events accounted for more than 25% of all apnea and hypopnea episodes, or if the AHI score while the person was not in a supine position was less than 10 events per hour. Participants were also excluded if pronounced anatomical abnormalities preventing the effective use or assessment of upper-airway stimulation were identified during the surgical consultation (e.g., tonsil size of 3 or 4 [tonsils visible beyond the pillars or extending to midline]) or if complete concentric collapse at the retropalatal airway was observed on endoscopy performed during drug-induced sleep. Qualified participants underwent a surgical procedure to implant the upper-airway stimulation system (Inspire Medical Systems). The stimulation electrode was placed on the hypoglossal nerve to recruit tongue-protrusion function; the sensing lead was placed between the internal and external intercostal muscles to detect ventilatory effort; the neurostimulator was implanted in the right ipsilateral mid-infraclavicular region.