The Centers for Medicare & Medicaid Services (CMS), Division of Outpatient Care, has confirmed that CPT code 64590 applies to eCoin, a leadless tibial neurostimulator approved by the FDA for the treatment of urinary urge incontinence (UUI).1
Valencia Technologies, the developer of eCoin, reported in a press release that the CMS had responded to its New Technology Ambulatory Payment Classification (APC) application with a letter stipulating that, “the eCoin technology did not qualify for a New Technology APC assignment because it is already described by existing CPT code 64590. According to Valencia, CPT code 64590 is assigned to APC 5464.
The company also explained in its press release that the CY2023 unadjusted, national average payment rate for CMS Hospital Outpatient APC 5464 is US$21,515.36 (CY22 US$20,912.55). Additionally, the CY2023 ASC unadjusted, national average payment rate for APC 5464 is US$19,333.45 (CY22 US$18,431.64).
"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," Ann Decker, vice president of Reimbursement for Valencia Technologies, stated in a press release. "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."
The FDA approved the eCoin in March 2022 for the treatment of UUI, a condition experienced by more than 60% of patients with overactive bladder.2
The approval was based on results from a pivotal, open-label, single-arm trial that were previously published in the Journal of Urology.3 The eCoin device met the primary end point of the study by achieving a ≥50% improvement in UUI in 68% of patients after 48 weeks of treatment.
The eCoin device is a tibial neurostimulator that is the shape and size of a nickel. It is implanted in the lower leg under local anesthetic in an office or outpatient procedure by a urologist or urogynecologist. The procedure takes about 20 minutes.
Overall, the open-label, single-group assignment pivotal trial of eCoin (NCT03556891) included 133 patients with OAB with UUI. eCoin was a third- or fourth-line OAB therapy for these patients, who went through a washout period for any OAB medications. OAB drugs were not allowed during the trial. There was no screening prior to device implantation.
There were 132 patients included in the intent-to-treat population. Baseline characteristics from these patients showed that the mean age was 63.9 years, 98% of patients were female, 84% were white, and the mean number of daily UUI episodes was 4.3. Based on patient reporting, the mean history of OAB was 11 years.
Device implantation was performed under local anesthesia and the mean time from initial incision to the final suture was 19.8 minutes. The primary efficacy end point was the rate of patients having a ≥50% improvement in UUI episodes as measured by a 3-day voiding diary at 48 weeks following activation of eCoin.
At 28 and 52 weeks, the rate of device-related adverse events (AEs) was 15%. AEs related to device or procedure were generally considered to be mild to moderate. At 52 weeks post-implantation, 19% of patients had AEs related to either the procedure or device. The specific incidence of device-related events at 52 weeks of treatment was 16%. There was 1 serious AE, consisting of an infection related to the study procedure. According to the investigators, this resulted in an explant, which investigators were able to resolve without sequelae.
Patients feedback also showed that one year after the procedure, 81% of patients indicated they felt "better" to "very much better." Additionally, 89% of patients reported they would recommend eCoin treatment to their family or friends.
1. CMS Confirms CPT Code 64590 for eCoin® Tibial Neurostimulator. Published online and accessed December 14, 2022. https://prn.to/3C42Tcb
2. Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence. Published online March 2, 2022. Accessed March 2, 2022. https://bit.ly/35LnYug
3. Rogers A, Bragg S, Ferrante K, et al. Pivotal study of leadless tibial nerve stimulation with eCoin ® for urgency urinary incontinence: an open-label, single arm trial. J Urol. 2021;206(2):399-408. doi: 10.1097/JU.0000000000001733