LCD L38276: Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Hypoglossal nerve stimulation (HNS) is reasonable and necessary for the treatment of moderate to severe obstructive sleep apnea (OSA) 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/m 2 ; and

• A polysomnography (PSG) demonstrating an apnea-hypopnea index (AHI) of 15 to 65 events per hour within 24 months of initial consultation for HNS implant; and

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

• Shared Decision-Making (SDM) between the Beneficiary, Sleep physician, AND qualified otolaryngologist (if they are not the same) who determines that the Beneficiary demonstrates continuous positive airway pressure (CPAP) failure (defined as AHI greater than 15 despite CPAP usage) or CPAP intolerance (defined as CPAP machine-derived compliance reporting with usage less than 4 hours a night for at least 70% of the nights in 1 month, or the CPAP has been returned) despite CPAP interface and/or setting optimizations.

• Confirmed absence of complete concentric collapse at the soft palate level by a drug-induced sleep endoscopy (DISE) procedure; and

• Absence of anatomical findings that would compromise performance of device (e.g., tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale).

• Use of HNS devices with United States (U.S.) Food and Drug Administration (FDA)-approval for implantation to treat OSA (e.g., Inspire ® II Upper Airway Stimulator ).

HNS is not reasonable or necessary when any 1 of the following contraindications are present:

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

• BMI 35 kg/m 2 or greater

• 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

• Acute psychiatric disease

• Coexisting non-respiratory sleep disorders that would confound functional sleep assessment

• Beneficiaries who are, or who plan to become pregnant

• Beneficiaries who are unable or do not have the necessary assistance to operate the device's external programmer

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

• HNS implant devices that are not compatible with magnetic resonance imaging (MRI) in Beneficiaries who require MRI

NOTE: Beneficiaries with certain HNS devices can undergo MRI of the head and extremities if certain conditions and precautions are met. Please refer to the Manufacturer Guidelines for the relevant model for more information.

Credentialing and Accreditation Standards

Provider Qualifications for HNS Implantation and Device Management

Optimal outcomes of HNS implantation procedures depend on the knowledge, skill and experience of the provider(s). Consequently, the qualified provider performing the procedure must be capable of demonstrating documented training and experience relevant to HNS implantation.

HNS-implantation services will only be considered reasonable and necessary if provided in facilities with standards of medical practice and personnel appropriate for the patient’s medical needs, risk of adverse events, and when performed by qualified providers with all of the following:

All HNS implantation procedures must be performed by a licensed qualified physician

A licensed qualified physician (MD or DO) for HNS services is defined as:

Having trained and acquired expertise within the framework of an accredited residency or fellowship program in the applicable specialty/subspecialty (e.g., Board-eligible (BE) or Board-certified (BC) otolaryngologist ) or must reflect equivalent education, training and expertise endorsed by a relevant specialty/subspecialty society, and

Prior to implanting the system, surgeons will have received education and proctoring by an FDA-approved device manufacturer or equivalent proctoring body on device implant techniques, including cadaver training. Documentation must be available for contractor review to provide confirmation of proficiency in the performance and management of HNS implantation and the corresponding relevant devices.

The provider performing DISE 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. Documentation of this proficiency must be available to submit for contractor review.

Excluding routine post-op care by the implanting surgeon (e.g., initial empiric programming) , initial consultation and post-implant evaluation and management of Beneficiaries appropriate for HSN devices must be performed by BE or BC Sleep physicians with qualifications as outlined in LCD L36593 [Polysomnography] and Article A55958 [Accreditation and Credentialing Requirements for Polysomnography LCD L36593]. Additionally, sleep studies shall be performed by an accredited sleep facility as stated in LCD L36593. Please refer to the Article A55958 regarding Independent Diagnostic Testing Facility (IDTF) for additional information. BC/BE Sleep physicians must complete HNS device education and training (including hands-on operation of the external programmer) by an FDA-approved device manufacturer or equivalent proctoring body.

OSA is a common, chronic disorder characterized by recurrent narrowing and/or closure of the upper airway accompanied by intermittent oxyhemoglobin desaturation, arousal from sleep and sympathetic activation. 1,2 Sequelae include disturbed sleep, excessive sleepiness and impaired quality of life (QOL). Moderate-to-severe OSA, defined as an AHI score of 15 or more apnea/hypopnea events per hour, is an independent risk factor for insulin resistance, dyslipidemia, vascular disease, and death. 3-7 Treatment with CPAP improves disturbed sleep; however, the general effectiveness of CPAP therapy is dependent on patient acceptance of and adherence to the treatment. 8,9 There are no effective options for patients with moderate-to-severe OSA for whom CPAP is ineffective or intolerant.

HNS has demonstrated safety and efficacy

Stimulation of the hypoglossal nerve that innervates the genioglossus is now a new therapeutic option for moderate and severe cases of obstructive sleep apnea-hypopnea syndrome (OSAHS). Two types of stimulation are currently available: (a) stimulation synchronous with inspiration and (b) continuous stimulation. Delgado, et al. concluded that indication of each type of stimulation and long-term effects still need to be assessed, but the implantable nerve stimulation is a promising treatment for patients without a therapy solution so far. 10 In a multi-center, prospective, cohort study, Gillespie, et al. (2017) evaluated patient-based outcomes of subjects in a large cohort study (the Stimulation Therapy for Apnea Reduction [STAR] trial) 48 months after implantation with an upper airway stimulation (UAS) system for moderate-to-severe OSA. Patients (n = 91) at 48 months from a cohort of 126 implanted participants were included in this analysis. 11 A total of 126 subjects received an implanted UAS system in a prospective phase III clinical trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with pre-implantation baseline. A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced (p = 0.01), and sleep-related QOL as measured by FOSQ significantly improved (p = 0.01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners; 2 patients needed additional surgery without complication for lead malfunction. The authors concluded that UAS maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate-to-severe OSA. The authors stated that the main drawback of this study was the increased number of patients lost to follow-up at 48 months compared with 36 months (25 versus 4). Factors that influence adherence to follow-up include individual patient characteristics, social support, medical staff characteristics, and research study design. The trend of older age for those who completed follow-up versus those lost at 48 months was consistent with other trials that have noted poorer follow-up in younger cohorts, perhaps due to increased demands of work-life balance among younger subjects. With regard to medical staff, loss of a principal investigator and study-site support accounted for 20% of follow-up loss at 48 months. This trial, like many other multi-year trials, experienced greater loss of follow-up after 3 years. They noted that ongoing follow-up is needed to determine the natural product life of the device components.

In a prospective, multi-center, single-arm study, Steffen, et al. (2018) reported objective and patient-reported outcome after 12 months of implantation. Consecutive patients who received the UAS system (Inspire ® Medical Systems, Inc., Minneapolis, MN) were enrolled in 3 German centers. 12 Key study exclusion criteria included BMI greater than 35 kg/m 2 , AHI less than 15 or greater than 65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12- month visit include home sleep test and patient-reported outcome measures. Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in ESS and FOSQ both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device; 1 patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. The authors concluded that the findings of this study supported that UAS is a safe and effective therapeutic option for patients with OSA in routine clinical practice. However, the level of evidence was limited (IV) as this was an uncontrolled study with relatively small study with short-term follow-up.