On November 26, 2025, Nyxoah SA, a leading medical technology company specializing in breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), announced a pivotal update for its Genio® Therapy system as the U.S. Centers for Medicare & Medicaid Services (CMS) finalized its CY2026 Hospital Outpatient Prospective Payment System (HOPPS) and Ambulatory Surgery Center (ASC) Rule. Effective January 1, 2026, the CMS has reclassified CPT Code 64568—the billing code for all Genio hypoglossal nerve stimulation (HGNS) implants—under New Technology Ambulatory Payment Classification (APC) 1580. This action significantly elevates the reimbursement framework for hospitals and ambulatory surgical centers adopting this technology, providing strong incentives for broader utilization of Genio® Therapy in managing OSA.

The net result of the CMS ruling is a substantial reimbursement increase for both hospital outpatient departments (HOPD) and ASCs delivering Genio® HGNS implants. Specifically, HOPD reimbursement for CPT 64568 will rise to approximately $45,000 per procedure, reflecting a 48% increase compared to 2025 levels. Likewise, ASC facility reimbursement will increase to $42,373, a 58% uplift over current rates. These changes establish a uniform reimbursement environment for all procedures utilizing the Genio® system and provide economic stability that will support hospital and ASC adoption strategies. This move is pivotal for hospital administrators, financial officers, and procurement leaders evaluating investments in innovative sleep apnea treatment modalities.

Nyxoah’s Genio® system is a single-incision, leadless, battery-free hypoglossal neurostimulation device that offers a patient-centered alternative for treating OSA—a condition linked to increased mortality, cardiovascular events, and chronic resource utilization. The device’s favorable site-of-service profile, especially for ASCs, means facilities can optimize procedural throughput, diversify offerings, and capture new patient demographics. The new reimbursement structure is expected not only to promote access for Medicare populations but also to strategically position hospitals and ASCs in competitive regional markets pursuing differentiation in sleep medicine.

Olivier Taelman, Nyxoah’s Chief Executive Officer, highlighted that CMS’s decision significantly improves the economic environment for Genio® Therapy adoption, reinforcing the therapy’s value among high-cost, high-burden OSA patient groups. The announcement also follows positive outcomes from the DREAM IDE pivotal study, along with recent FDA approval for Genio® in a defined adult OSA population (apnea-hypopnea index between 15 and 65), positioning hospitals to lead in evidence-based, reimbursable interventions for sleep-disordered breathing.

For hospital and healthcare facility leaders, the implications are impactful: capital planning and strategic service line expansion can now confidently incorporate Genio® Therapy, knowing that future reimbursement stability makes investments in education, care team training, and patient outreach sustainable. The rules set forth by CMS are part of a broader movement toward incentivizing medical innovation and supporting high-value, minimally invasive procedures in outpatient and ASC environments—aligning with health systems’ goals to lower inpatient costs and expand revenue streams in outpatient care.

Administrators and clinical leaders should now assess the readiness of their facilities to adopt Genio® Therapy, taking into account the new financial terms, eligibility criteria for patient populations, and the competitive advantages gained by early adoption. As CMS continues to update reimbursement models in response to clinical innovation, hospitals and ASCs able to demonstrate quality outcomes and efficient utilization of advanced therapeutics like Nyxoah’s Genio® system will be better positioned to capture value-based payments and improve both patient and organizational outcomes in respiratory and sleep medicine.