The U.S. Centers for Medicare & Medicaid Services finalized its 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgery Center rule on November 26 2025, assigning Nyxoah’s Genio hypoglossal nerve‑stimulation therapy to CPT code 64568 and classifying it as a New Technology APC 1580. The rule takes effect on January 1 2026 and applies uniformly to all procedures billed under the code.
Under the new rule, reimbursement for Genio implants in hospital outpatient departments rises to approximately $45,000, a 48 % increase over 2025 levels. Facility payments for ambulatory surgery centers climb to $42,373, a 58 % jump. The higher rates are designed to strengthen the economic foundation for therapy adoption across U.S. hospitals and ASCs, removing a key financial barrier to widespread use.
The reimbursement boost is a significant catalyst for Nyxoah’s U.S. commercialization strategy. By raising the price point, the company can accelerate implant volumes, move closer to its target of $250 million in U.S. sales, and extend its cash runway through the planned $77 million financing. The higher rates also improve gross margins, as the cost of goods sold for Genio remains stable while the reimbursement per implant increases.
CEO Olivier Taelman said the CMS decision “reinforces the growing recognition of hypoglossal nerve stimulation as a high‑value therapy for obstructive sleep apnea and creates a more favorable environment for expanding access to Genio across both outpatient hospitals and ASCs.” The rule also includes a 2.6 % overall increase in Medicare outpatient payment rates and introduces site‑neutral payment policies, but the Genio benefit stands out as a targeted incentive for this specific therapy.
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