VALENCIA, Calif., July 11, 2024 /PRNewswire/ —
Valencia Technologies Corporation announced today that the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), published the 2025 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule with information relevant to the eCoin® system procedure.
The technology is a pioneering, leadless implantable tibial nerve stimulation (ITNS) system for treating urgency urinary incontinence (UUI).
In the Proposed Rule issued Wednesday, July 10, 2024, CMS defined that the existing Category III CPT code 0816T, which describes the eCoin ITNS procedure, will remain assigned to Hospital Outpatient Prospective Payment System Ambulatory Payment Classification (APC) 5464 for Calendar Year 2025, with a proposed unadjusted national average payment rate of US$21,063, as referenced in the Addendums A and B of the Proposed Rule.
Notably, due to the efforts of the Valencia Technologies Reimbursement Team in their dialogue with CMS, a favorable adjustment to the CY 2024 Ambulatory Surgical Center (ASC) payment rate was achieved. The proposed national unadjusted ASC payment rate for CY2025 for code 0816T is $19,464, representing a 38% increase over the CY2024 rate of $14,122.
The eCoin System is the first and only US Food and Drug Administration (FDA) PMA approved implantable medical device to target the tibial nerve for the treatment of urgency urinary incontinence.
Ann Decker, VP of Reimbursement for Valencia Technologies, stated, “The cumulative effect of the proposed 2025 continuation of APC assignment 5464, the improved ASC payment rate, and the recognition of ITNS as a minimally invasive OAB treatment option in the recently updated guidelines by the American Urological Association (AUA) and the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU), underscores that the eCoin ITNS system will have a strong reimbursement pathway throughout 2025 and beyond. I could not be prouder of the diligence and tenacity of the Valencia Team in building a robust, sustainable reimbursement foundation that will allow more patients suffering from UUI to access our innovative technology. Our efforts are focused on ensuring patient access to the eCoin ITNS system to find relief from their symptoms.”
The eCoin device is a coin-sized neurostimulator implanted subcutaneously in the lower leg during a minimally invasive, outpatient procedure utilizing local anesthetic. The eCoin device contains a primary battery and once activated, automatically delivers intermittent stimulation to the tibial nerve twice weekly to reduce UUI symptoms without requiring the need for patient management. The procedure is less invasive than traditional sacral neuromodulation surgery for treating UUI, which typically requires a multi-phase approach, the need for sedation or general anesthesia, and patient management of an external remote and possibly other recharging components.
The eCoin system received FDA premarket approval (PMA) in the USA in March 2022 and is currently available throughout the United States.
Physicians interested in offering eCoin ITNS therapy may register for the eCoin Physician Qualification training program using the eCoin physician website at professionals.eCoin.us. Patients are encouraged to visit Valencia’s patient website at www.eCoin.us for more information about this novel therapy for UUI.
Forward-looking Statements
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Valencia undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.
CPT® codes and descriptions are copyright 2023 American Medical Association (AMA). All rights reserved. CPT® is a registered trademark of the American Medical Association. Applicable FARD/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT®, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
