The rule includes a proposed unadjusted national average payment rate of US$21,376.53 for the device in 2024.
The Centers for Medicare & Medicaid Services (CMS) has issued the 2024 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems Proposed Rule with information regarding coding and reimbursement for the use of the eCoin tibial neurostimulator for the management of urgency urinary incontinence (UUI).1,2
The proposed rule poses that the category 3 code X129T is assigned to OPPS Ambulatory Payment Classification (APC) 5464 for the 2024 calendar year. The CPT code X129T was approved by the American Medical Association CPT Editorial Panel earlier in 2023 to report the insertion or replacement of the device in patients with bladder dysfunction. The reporting of procedures with this device to Medicare, Medicare Advantage, and commercial health plans will be effective starting on January 1, 2024.
The newly issued proposed rule also includes a proposed unadjusted national average payment rate of US$21,376.53 for the device in 2024.
"The APC assignment determination made by CMS marks a significant milestone for the eCoin system procedure and will ensure that our innovative technology has a continued reimbursement path into 2024 and beyond. Given the widespread prevalence of urgency urinary incontinence, Valencia Technologies is quite pleased to see our innovation contribute to the treatment and recognition of a typically underserved medical condition. These coding and payment decisions are consistent with the strong, published clinical evidence demonstrating the safety and effectiveness of the eCoin device for the treatment of urgency urinary incontinence,” said Ann Decker, in a news release.1 Decker is the vice president of reimbursement for Valencia Technologies.
The CMS final rule will be issued in early November following a 60-day comment period.
The eCoin tibial neurostimulator was granted FDA approval in March 2022 for the treatment of patients with UUI.3
The approval was based on findings from a pivotal, open-label, single-arm trial (NCT03556891) in which the device met the primary end point of a 50% or greater decrease in UUI episodes after 48 weeks of therapy.4
In total, 132 patients were included in the intent-to-treat population and underwent device implantation under local anesthesia. Of those, 68% experienced at least a 50% reduction in UUI episodes after 48 weeks of treatment.
At 52 weeks post-implantation, 19% of patients had adverse events (AEs) related to either the procedure or device. The specific incidence of device-related events through 52 weeks of treatment was 16%. There was 1 serious AE, consisting of an infection related to the study procedure, which resulted in an explant that investigators were able to resolve without sequelae.
According to patient-reported feedback, 81% of patients indicated they felt "better" to "very much better" at 1 year following the procedure. Further, 89% of patients indicated that they would recommend eCoin treatment to their family or friends.
1. CMS recognizes Valencia Technologies’ eCoin System coding and payment in 2024 proposed Medicare rule, advancing treatment for urgency urinary incontinence. News release. Valencia Technologies Corporation. July 17, 2023. Accessed July 18, 2023. https://www.prnewswire.com/news-releases/cms-recognizes-valencia-technologies-ecoin-system-coding-and-payment-in-2024-proposed-medicare-rule-advancing-treatment-for-urgency-urinary-incontinence-301878512.html
2. CY 2024 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS 1786-P). News release. CMS.gov. July 13, 2023. Accessed July 18, 2023. https://www.cms.gov/newsroom/fact-sheets/cy-2024-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center#:~:text=are%20not%20met.-,In%20the%20CY%202024%20OPPS%2FASC%20proposed%20rule%2C%20CMS%20is,Network%20measure%20specifications%3B%20(2)
3. Valencia Technologies Announces FDA Approval of eCoin® Therapy to Treat Urinary Urge Incontinence. News release. Valencia Technologies Corporation. March 2, 2022. Accessed July 18, 2023. https://www.prnewswire.com/news-releases/valencia-technologies-announces-fda-approval-of-ecoin-therapy-to-treat-urinary-urge-incontinence-301493440.html
4. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. Pivotal study of leadless tibial nerve stimulator with eCOIN for urgency urinary incontinence: an open-label, single arm trial. J Urol. 2021 Aug;206(2):399-408. doi:10.1097/JU.0000000000001733