Appeal type: unknown
Decision: unknown

 
The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. 
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101. 
 
The rules say that 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). 
 
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 patients ability to operate the HNS and report problems to the attending provider. 
        Coexisting nonrespiratory 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 manufacturers 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 patients record by the referring physician and the implanting physician. 
Both shall provide these documents if requested by this contractor. 
 
Local Coverage Determination (LCD) Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep 
Apnea L38528. 
 
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com. 
 
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.