LivaNova’s VNS Therapy for Drug-Resistant Epilepsy Procedures Receives Increased Provider Reimbursement from U.S. Centers for Medicare & Medicaid Services

– New patient implants assigned to New Technology Ambulatory Payment Classification 1580

– End-of-service procedures elevated to Level 5 APC

– Effective Jan. 1, 2026, will improve economics for hospitals performing Medicare procedures and significantly reduces a known barrier to procedure penetration

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) assigned VNS Therapy™, a LivaNova neuromodulation treatment for patients 4 years of age and older with Drug-Resistant Epilepsy (DRE) and focal seizures, to New Technology Ambulatory Payment Classification (APC) 1580 for new patient implants (NPIs) under the 2026 Medicare Hospital Outpatient Prospective Payment System. CMS also moved VNS Therapy end-of-service (EOS) procedures from Level 4 into the Level 5 APC.

Effective Jan. 1, 2026, provider reimbursement for VNS Therapy DRE procedures under Medicare will increase significantly, with hospital outpatient payments rising by approximately 48% for NPIs and 47% for EOS procedures versus 2025 rates. LivaNova expects this shift will improve hospital economics for VNS Therapy, creating a more sustainable financial foundation for providers and paving the way for expanded patient access. The changes also significantly reduce a known barrier to procedure penetration as current hospital reimbursement rates for Medicare patients often do not fully cover procedure costs.

“We welcome CMS’s reimbursement increases for both new patient implants and end-of-service procedures, which we view as an important milestone for the significantly underserved DRE community,” said Stephanie Bolton, LivaNova President, Global Epilepsy. "These positive CMS actions will better support hospitals in offering VNS Therapy to eligible patients, driving expanded patient access and broader adoption. LivaNova appreciates the support of our hospital and physician community, patient advocacy groups, and the CMS Hospital Outpatient Physician Advisory Panel, and we thank CMS for its ongoing commitment to open dialogue to expand patient access to this important therapy.”

This pivotal reimbursement adjustment will broaden access to VNS Therapy, which offers significant reduction in seizure frequency, severity, and, for some patients, provides seizure freedom. The recently completed CORE-VNS study, the largest real-world neuromodulation study for epilepsy, illustrated that VNS Therapy delivers an overall median seizure reduction at 36 months of 80% for focal onset motor seizures with impaired awareness, and 95% for focal to bilateral tonic-clonic seizures¹. This powerful effectiveness is paired with a low-risk, simple, extra-cranial outpatient procedure, with the most common side effects being hoarseness, sore throat, shortness of breath, and coughing. Patients and caregivers overwhelmingly value this treatment: 94% of 200 recently surveyed VNS Therapy patients and caregivers said they wish they had discovered VNS Therapy sooner².

References

About VNS Therapy™ for Epilepsy

VNS Therapy™ is clinically proven safe and effective as an add-on treatment to reduce the frequency of seizures in adults and children as young as 4 years old with drug-resistant epilepsy and partial onset seizures. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects approximately one in three people with epilepsy. Unlike some other surgical treatment options for people with drug-resistant epilepsy, VNS Therapy implantation involves an outpatient procedure and does not require penetration of the skull. Outside the United States, the VNS Therapy indications for use may vary. For more information, including complete safety information, visit VNSTherapy.com.

About LivaNova

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a vision to change the trajectory of lives for a new day. Through ingenious medical solutions in select neurological and cardiac conditions, LivaNova strives to ignite patient turnarounds. Headquartered in London, with approximately 3,000 employees and a presence in more than 100 countries, LivaNova serves patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding products or therapies, their associated reimbursement rates, and expectations regarding adoption of VNS Therapy. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251124691172/en/