Valencia Technologies Corporation announced today that the Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS), published the 2024 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule with information relevant to the eCoin system procedure.

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Nov 07, 2023, 08:04 ET

The eCoin^® system is a pioneering, leadless tibial neurostimulator for the treatment of urgency urinary incontinence (UUI).

VALENCIA, Calif., Nov. 7, 2023 /PRNewswire/ -- As outlined in the 2024 Medicare Program: HOPPS and ASC Payment Systems Final Rule, CMS has confirmed that new Category III CPT code 0816T for reporting the eCoin system implantable tibial nerve stimulation procedure across all service locations has been assigned to Medicare Hospital Outpatient Prospective Payment System Ambulatory Payment Classification (APC) 5464 beginning CY'24. In the hospital outpatient site of service, APC 5464 has been assigned a Medicare unadjusted, national average payment rate of US$20,865, as referenced in Addendums A and B of the Final Rule.

Furthermore, CPT code 0816T describing the eCoin system procedure has been categorized as device-intensive by CMS. This categorization ensures a more comprehensive Medicare payment in the Ambulatory Surgery Center (ASC) in comparison to procedures not deemed device-intensive. The Medicare unadjusted, national average payment for CPT code 0816T in an ASC setting beginning 2024 is $14,130, when medical necessity criteria are met.

Uniquely, the eCoin System has the honor of being the only US Food and Drug Administration (FDA) PMA approved subcutaneously implantable medical device designed to stimulate the tibial nerve for treatment of urgency urinary incontinence (UUI).

Ann Decker, VP of Reimbursement for Valencia Technologies, commented, "The payment Rules for Hospital outpatient (HOPPS) and Ambulatory Surgery Center (ASC) by CMS are a testament to the constructive discussions between Valencia Technologies and CMS. Such determinations by CMS signify a remarkable advancement for the eCoin system, reinforcing the continued, apt facility reimbursement in 2024, and beyond, for our groundbreaking solution for treating UUI. We are thrilled to witness our pioneering work play a pivotal role in addressing this often-overlooked medical condition. Both the AMA's and CMS's recent coding and payment determinations echo the robust clinical evidence available that underscores the safety and effectiveness of the eCoin device in managing urgency urinary incontinence."

The eCoin^® device is a coin-sized neurostimulator which is 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 patient involvement. The procedure is less invasive than traditional sacral neuromodulation surgery for treating UUI which typically requires a multi-phase approach, need for sedation or general anesthesia, and patient management of a remote and possibly other recharging components.

The eCoin system received FDA premarket approval (PMA) in the USA in March 2022 for the treatment of urgency urinary incontinence (UUI) and is currently available throughout the United States. According to the Urology Care Foundation UUI is the most bothersome symptom associated with OAB syndrome, and most patients afflicted with this condition remain untreated for this chronic problem that can dramatically impair overall health and quality of life.¹

Physicians interested in offering eCoin^® therapy to their patients 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 2024 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.