Anthem Blue Cross and Blue Shield Announces Coverage for the eCoin System for Urinary Incontinence

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Jan 09, 2024, 07:00 ET

VALENCIA, Calif., Jan. 9, 2024 /PRNewswire/ --Valencia Technologies Corporation announced today that Anthem Blue Cross and Blue Shield published a coverage policy for the eCoin^® System procedure effective December 28, 2023. The eCoin system is an innovative, implanted, leadless tibial neurostimulator for the treatment of urgency urinary incontinence (UUI), secondary to overactive bladder (OAB).

Effective December 28, 2023, Anthem Blue Cross and Blue Shield announced in a published medical policy their decision to cover the eCoin^® System implantable tibial nerve stimulation (TNS) procedure when medical necessity criteria are met. As the second largest health plan in the U.S., Anthem BCBS represents over 33 million covered individuals across the U.S.

Uniquely, the eCoin^® System is the only U.S. Food and Drug Administration (FDA) PMA-approved, fully integrated, subcutaneously implantable medical device designed to automatically stimulate the tibial nerve for treatment of urgency urinary incontinence (UUI). Effective January 1, 2024, the eCoin^® procedure is reported using CPT code 0816T.

Ann Decker, VP of Reimbursement for Valencia Technologies, commented, "This Anthem coverage is the result of ongoing constructive dialogue between Valencia Technologies and Anthem. The coverage decision by Anthem highlights the strength of the published clinical data supporting the safety and efficacy of the eCoin^® system implantable tibial nerve stimulation (TNS) technology, as well as the patient outcomes demonstrated both in previous clinical trial and since the eCoin^® device became commercially available in 2022. We couldn't be more pleased that our efforts resulted in early coverage adoption from an influential health plan like Anthem Blue Cross and Blue Shield." Further, Ms. Decker comments, "There is nothing more satisfying than to know a growing number of patients seeking a permanent solution for treating their chronic and refractory symptoms of UUI will now have a clear path to the eCoin^® implantable TNS technology."

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-cell 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.

Media Contact:
Shawn Graft
sgraft@valenciatechnologies.com

SOURCE Valencia Technologies Corporation