Centers for Medicare & Medicaid Services Finalizes 2024 Hospital Outpatient Payment for Subfascial Implantable Tibial Neuromodulation Procedure
Facility Payment approved by CMS effective January 1, 2024, for Revi subfascial procedure
PARK CITY, Utah, November 6, 2023 — BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI) announced today that as part of the Calendar Year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) final rule, the Centers for Medicare & Medicare Services (CMS) have finalized the facility payment for subfascial procedures for tibial neuromodulation that pertain to its Revi device. In the final rule, CMS determined that the new subfascial tibial neuromodulation CPT code, 0817T, will be assigned to Ambulatory Payment Classification (APC) 5464 for hospital outpatient services with an unadjusted national average payment rate of USD $20,854.
The establishment of payment, which is effective January 1, 2024, will enable access to cutting-edge care for Medicare beneficiaries with UUI who could benefit from Revi, a new treatment for this debilitating condition. The US Food and Drug Administration (FDA) granted a De Novo marketing request on August 16, 2023, for Revi, a transformative iTNM therapy, for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. In addition, the FDA noted that clinicians should follow clinical guidelines and use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using Revi. Revi is the only subfascial iTNM system on the market and features a miniature implant along with innovative wearable technology to power the device. Revi is implanted near the ankle during a single outpatient procedure performed under local anesthesia, with or without sedation, and without the potential adverse events seen with other surgical UUI therapies. When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI. For activation, a lightweight wireless wearable is placed around the ankle once to twice daily to provide stimulation at the patient’s convenience.
In October the American Medical Association (AMA) CPT Editorial Panel announced the final Current Procedural Terminology (CPT) code to describe the subfascial tibial neuromodulation implant procedure, 0817T, which is also effective January 1, 2024. CPT codes are used by providers to report medical services and procedures to Medicare and commercial health plans for reimbursement.
“We applaud CMS and the AMA for recognizing the value and importance of the subfascial tibial neuromodulation procedure and Revi technology,” said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. “BlueWind Medical is changing the treatment paradigm for UUI by offering a patient-centric alternative to less effective or less convenient third line therapies, and to medications, which are often less effective and that can trigger troublesome side effects. Revi offers a safe and effective solution for the countless individuals and will be a welcome alternative to current therapy.”
About BlueWind Medical Ltd.
BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall wellbeing of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind’s Revi System is the first and only battery-free implantable tibial neuromodulation device to receive FDA marketing authorization for patients with UUI.