Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

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.