BlueWind Medical, Ltd., a leader in implantable Tibial Neuromodulation (iTNM) and developer of the Revi® System for treating urge urinary incontinence (UUI), announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a positive payment adjustment for the 2025 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems Rule. This adjustment will enhance reimbursement rates for the Revi® System.
For CY2025, the Centers for Medicare & Medicaid Services (CMS) has set the national unadjusted payment rate for Category III CPT code 0817T, which includes the Revi® System, at $19,839—a 40% increase from the CY2024 rate. In the Hospital Outpatient setting, the CY2025 payment rate increased by 3% to $21,444. These changes underscore CMS’s recognition of the Revi System’s clinical benefits as a minimally invasive and effective solution for treating urge urinary incontinence (UUI).
“We are pleased that CMS has increased reimbursement rates for the Revi System in the ASC setting,” said Steve Armstrong, CFO and General Manager of BlueWind Medical. “This decision reflects growing recognition of implantable Tibial Neuromodulation (iTNM) as a proven, minimally invasive therapy for UUI, further validating the Revi System’s safety, durability, and patient satisfaction.”
The Revi System is the first FDA-cleared iTNM device for UUI, activated by an external, wireless wearable that allows patients to initiate therapy at their convenience. This innovative, patient-centric approach, combined with flexible treatment options for healthcare providers, offers effective UUI relief by stimulating the posterior tibial nerve.
As the first iTNM device cleared for use without requiring prior failure of conservative treatments, Revi aligns with updated 2024 guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). These guidelines advocate for early consideration of minimally invasive treatments for UUI and emphasize shared decision-making in managing overactive bladder (OAB) and UUI. Revi’s unique positioning enables it to be considered early in the treatment continuum, providing an alternative to patients dissatisfied with current therapies.
Recent clinical data further supports the efficacy, safety, and patient satisfaction of the Revi System for UUI treatment. Two-year results from BlueWind Medical’s pivotal OASIS Study were presented at both the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week and the International Continence Society (ICS). Additional research highlights iTNM as a viable alternative to Sacral Neuromodulation (SNM) for OAB and UUI.
About BlueWind Medical, Ltd.
BlueWind Medical is transforming neuromodulation therapy with innovative, patient-centered technologies for disease treatment. Initially focused on urge urinary incontinence (UUI), BlueWind’s Revi® System is the first FDA-cleared implantable tibial neuromodulation device activated by a wearable, external battery-operated device. Unlike other therapies, Revi does not require patients to fail or not tolerate conservative treatments before it can be used, offering greater flexibility in managing UUI.
