Valencia Technologies Corporation announced today that the Centers for Medicare & Medicaid Services (CMS), Division of Outpatient Care issued a letter in response to Valencia Technologies’ New Technology APC application stating the eCoin technology did not qualify for a New Technology APC assignment because it is already described by existing CPT® code 64590. The eCoin® system is a leadless tibial neurostimulator for the treatment of urgency urinary incontinence (UUI). CPT code 64590 is assigned to Ambulatory Payment Classification (APC) 5464.
CMS Hospital Outpatient APC 5464 has a CY2023 unadjusted, national average payment rate of US$21,515.36 (CY22 US$20,912.55) and a CY2023 ASC unadjusted, national average payment rate of US$19,333.45 (CY22 US$18,431.64).
The eCoin System is the first US Food and Drug Administration (FDA) approved implantable medical device to treat urgency urinary incontinence in patient’s intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
“This is a major milestone and will help ensure that hospitals and ambulatory surgery centers can have confidence in the coding and reimbursement path for eCoin for qualified patients when medical necessity criteria have been met. Given the reported high prevalence of urgency urinary incontinence, this is a significant development toward recognizing and treating a poorly managed medical condition,” stated Ann Decker, VP of Reimbursement for Valencia Technologies. “CMS’s position is supported by published clinical evidence demonstrating the safety and effectiveness of the eCoin device for the treatment of urgency urinary incontinence.”
According to the Urology Care Foundation as many as 30 percent of men and 40 percent of women in the United States live with overactive bladder (OAB) symptoms. UUI is the most bothersome symptom of OAB syndrome.2 40M+ women in the US suffer from UUI.3 Most remain untreated for this chronic problem that dramatically impairs quality of life.
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. The device is available in the United States.
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.
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 2022 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.
2 Valencia 2019 Survey of Women with OAB.
3 Patel UJ, MD, Godecker AL, Giles DL, Brown HW. Updated prevalence of urinary incontinence in women. Female Pelvic Med Reconstr Surg. January 12, 2022.
Important Safety Information
The eCoin Peripheral Neurostimulator (“eCoin”) is part of the eCoin Peripheral Neurostimulator System (“eCoin System”) including device accessories. Indications: The eCoin is intended to be used to treat urgency urinary incontinence in patients intolerant to or having an inadequate response to other more conservative treatments or who have undergone a successful trial of percutaneous tibial nerve stimulation.
Contraindications: The eCoin is contraindicated for the following patients: ∙ Poor Surgical Candidates: The eCoin should not be implanted in patients who are poor surgical candidates. Poor surgical candidates include those who have open wounds or sores on the lower leg or foot; had prior surgery in the implant area; had previous, unhealed trauma in the implant area; pitting edema (≥2+) in the lower leg; venous disease/insufficiency in the lower leg; arterial disease/insufficiency in the lower leg; vasculitis or dermatologic conditions in the lower leg, infections near the implantation site in the lower leg. ∙ Patient cannot properly operate the Patient Controller Magnets and paper tape for use in the event of unintended or unwanted stimulation.
Warnings: Diathermy should not be used on patients implanted with the eCoin. The eCoin is MRI Conditional. It is not safe to have a patient’s lower leg placed in an MRI machine. Other medical procedures that may affect the eCoin System and should not be used in the implant area include: Monopolar electrosurgery; Microwave and Radiofrequency (RF) ablation; Radiation therapy over the eCoin; Ultrasound or scanning equipment. Electromagnetic Interference (EMI) generated by equipment found at home, work, or in public can interfere with the function of the eCoin System. Walkthrough metal detectors, security wands, or security archways should not affect the eCoin. Full-body security scanners used by the TSA are considered safe in patients that have a stimulator. The eCoin contains battery chemicals that could cause burns if the eCoin case were ruptured or pierced. Precautions: The safety and effectiveness of this therapy has not been established for Pregnant women; Patients under the age of 18; Patients with progressive, systemic neurological diseases; Bilateral stimulation. Potential Adverse Events: Implantation and use of the eCoin System incurs risk beyond those normally associated with surgery, some of which may necessitate intervention. In addition to the risks listed, there is a risk that eCoin therapy may not be effective in relieving symptoms or may cause worsening of symptoms. See the complete eCoin Physician Manual prior to use. RX only.