Is hypoglossal nerve stimulation (HNS) therapy, specifically the Inspire II system, medically necessary for a 60-year-old female with moderate to severe obstructive sleep apnea (OSA), a body mass index (BMI) of 34.7, and a history of intolerance to continuous positive airway pressure (CPAP) therapy, despite trying various masks and pressure changes?

Medical Necessity Assessment for Hypoglossal Nerve Stimulation

This patient does NOT currently meet medical necessity criteria for hypoglossal nerve stimulation (CPT 64568) and requires additional documentation before approval can be granted. 1

Critical Missing Documentation

The case lacks two essential eligibility criteria that must be satisfied:

• CPAP adherence monitoring is inadequate: The patient requires documented objective CPAP usage data showing either persistent AHI >15 despite CPAP use OR usage <4 hours per night for at least 5 nights per week over a minimum 1-month period. 1 The current documentation states "30 events per hour" while on CPAP but does not provide objective download data confirming adherence patterns or residual AHI measurements.

• DISE findings are incomplete: While "AP collapse" is documented, there is no explicit statement confirming the absence of complete concentric collapse at the soft palate level—this is an absolute contraindication to HNS therapy. 1, 2 The documentation states this criterion is "uncertain," which is insufficient for approval.

Criteria Assessment

Currently Met Criteria:

• Age ≥18 years: Patient is 60 years old 1
• BMI <40 kg/m²: Patient's BMI is 34.7 kg/m² 1
• Recent polysomnography: PSG performed within 24 months showing AHI 15.2 1
• AHI within range: AHI 15.2 falls within the required 15-100 events/hour range 1

Problematic Findings:

The AHI of 15.2 is at the lower threshold, and some guidelines suggest optimal outcomes occur with AHI 15-65 rather than up to 100. 2 However, this alone does not disqualify the patient.

The BMI of 34.7 kg/m² exceeds the more stringent threshold recommended by the European Respiratory Society (BMI <32 kg/m²) and Veterans Administration/Department of Defense guidelines (BMI <32 kg/m²), though it meets the American Academy of Sleep Medicine threshold of <40 kg/m². 1, 2 Weight reduction should be pursued concurrently, as lower BMI predicts better surgical efficacy and anatomical features. 1

Required Documentation Before Approval

1. Comprehensive CPAP Optimization Documentation:

• Objective CPAP download data showing nightly usage hours and residual AHI 1
• Documentation of specific CPAP pressures trialed 1
• Specific mask types attempted (nasal, full-face, nasal pillows) 1
• Evidence of heated humidification trial 1
• Documentation of pressure adjustments and troubleshooting interventions 1
• Consider BPAP trial if high pressures were the primary intolerance issue 1

2. Complete DISE Report:

• Explicit documentation stating "absence of complete concentric collapse at the soft palate level" 1, 2
• Complete anatomical assessment of all three major regions (palate, oropharynx, tongue base) 1
• Friedman staging for palate position and tonsil size 1

3. Additional Required Elements:

• Confirmation that central and mixed apneas comprise <25% of total AHI 1
• Documentation that no other anatomical findings would compromise device performance 1
• Confirmation of predominantly obstructive events on PSG 1

Treatment Algorithm Context

CPAP remains the gold standard first-line therapy for moderate-to-severe OSA, and this patient has appropriately attempted it. 1 HNS is established as an appropriate second-line therapy for CPAP-intolerant patients meeting strict eligibility criteria. 1, 2 The American Academy of Sleep Medicine, Veterans Administration/Department of Defense, and European Respiratory Society all endorse HNS in appropriately selected CPAP-intolerant patients. 1

Common Pitfalls to Avoid

• Do not approve without objective CPAP data: Subjective reports of intolerance are insufficient; objective download data is mandatory. 1
• Do not proceed without complete DISE confirmation: Complete concentric collapse at the soft palate level predicts HNS failure and is an absolute contraindication. 1, 2
• Do not delay weight reduction efforts: Concurrent weight loss improves both OSA severity and surgical outcomes. 1
• Do not consider mandibular advancement devices as an alternative: These are less effective than CPAP and inappropriate for moderate OSA (AHI >15), representing a therapeutic step-down. 1

Safety Profile

HNS therapy demonstrates a positive safety profile with pooled mortality rate of 0.01% (all deaths unrelated to HNS), system survival probability of 0.98 at 60 months, and surgical revision rate of 0.08%. 3 Most treatment-related effects are transient stimulation discomfort and tongue abrasions. 3 Long-term data confirms sustained safety and efficacy over ≥5 years. 1

Recommendation

Deny pending additional documentation. Request the specific objective CPAP adherence data and complete DISE report explicitly confirming absence of complete concentric collapse before reconsidering for approval. Once these criteria are documented, the patient would meet medical necessity for HNS therapy. 1, 2