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 state 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: 
1. Beneficiary is 22 years of age or older; and 
2. Body mass index (BMI) is less than 35 kg/m
2
; and 
3. A polysomnography (PSG) is performed within 24 months of first consultation for HGNS implant; and 
4. Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% 
of the total AHI); and 
5. AHI is 15 to 65 events per hour; and 
6. 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 
7. Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep 
endoscopy (DISE) procedure; and 
8. 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: 
1. Hypoglossal nerve neurostimulation is considered not medically reasonable and 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 being safe 
and effective. 
3. Hypoglossal nerve neurostimulation is considered not medically reasonable and necessary when any of 
the following contraindications are present: 
o Beneficiaries with central and mixed apneas that make up more than one-quarter of the total 
AHI. 
o Beneficiaries with an implantable device could experience unintended interaction with the 
HGNS implant system. 
o BMI equal to or greater than 35 
o Neuromuscular disease 
o Hypoglossal-nerve palsy 
o Severe restrictive or obstructive pulmonary disease 
o Moderate-to-severe pulmonary arterial hypertension 
o Severe valvular heart disease 
o New York Heart Association class III or IV heart failure 
o Recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months) 
o Persistent uncontrolled hypertension despite medication use 
o 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. 
o Coexisting non-respiratory sleep disorders that would confound functional sleep assessment 
o Beneficiaries who are, or who plan to become pregnant. 
o Beneficiaries who require Magnetic resonance imaging (MRI) with model 3024. 
o Beneficiaries, who require Magnetic resonance imaging (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. o Beneficiaries who are unable or do not have the necessary assistance to operate the sleep 
remote. 
o Beneficiaries with any condition or procedure that has compromised neurological control of the 
upper airway. 
You can find this rule at the Medicare Local Coverage Determination (LCD) L38312: Hypoglossal Nerve 
Stimulation for the Treatment of Obstructive Sleep Apnea. 
 
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.