MedRhythms has secured a new reimbursement code from the Centers for Medicare and Medicaid Services (CMS) for its stroke rehabilitation system, InTandem.
InTandem is designed to improve walking in chronic stroke patients.
The new Health Care Common Procedure Coding System (HCPCS) code, E3200, qualifies the system under Medicare's durable medical equipment benefit category.
Effective from 1 October 2024, the code will facilitate access to MedRhythms' rhythmic auditory stimulation (RAS) therapy, which has been clinically validated to enhance gait and ambulation in a home setting.
InTandem is engineered to deliver individualised, progressive RAS therapy, utilising wearable sensors and a control unit with adaptive algorithms.
The system's integration of hardware, software, and clinical best practices allows patients to independently engage in evidence-based interventions at home.
MedRhythms co-founder and CEO Brian Harris said: “The establishment of this HCPCS code offers new hope to chronic stroke patients who are battling walking deficits, and advances MedRhythms' mission to bring effective care to patients who need and deserve to have access to it.”
The InTandem system, which received FDA breakthrough device designation in 2020, was classified as a Class II medical device in July 2023.
It has demonstrated clinical benefits in a multi-site randomised controlled trial, indicating the safety and benefits of InTandem for chronic stroke gait impairment.
MedRhythms business development and corporate strategy vice-president Jennifer Lavanture said: “These CMS decisions are crucial developments in the path to provide access to this groundbreaking treatment to patients. MedRhythms commends CMS for their thoughtful consideration, and we greatly appreciate the time and efforts of the many patients, clinicians, and stakeholders who provided input and support throughout this process.”
Last year, MedRhythms announced the availability of its neurorehabilitation system InTandem by prescription for adults living with chronic stroke walking impairments.