PORTLAND, Maine—MedRhythms, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) established a new reimbursement code for the company's flagship product, InTandem, a clinically validated, prescription medical device that delivers rhythmic auditory stimulation (RAS) in the home to improve walking and ambulation in chronic stroke patients.
In its final determination, CMS established a new HCPCS code to describe InTandem: E3200 (gait modulation system, rhythmic auditory stimulation, including restricted therapy software, all components and accessories, prescription only). CMS also determined that InTandem qualified under Medicare's durable medical equipment (DME) benefit category based on InTandem's durability and indication for home use.
"The CMS decision to issue a new code for InTandem underscores recognition of this significant unmet need in chronic stroke," the company said in a news release. "A consistent barrier for patients with chronic stroke is a lack of access to rehabilitation once they have returned to the home."
"As a clinician, I'm far too familiar with the challenges stroke patients face in accessing treatment, particularly in the chronic phase of stroke recovery," said Brian Harris, MedRhythms' co-founder and CEO. "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."
InTandem delivers individualized, progressive RAS therapy in the home setting, producing gait quality and speed improvements to drive improved health outcomes and reduce the risk of adverse health events common in post-stroke patients. By leveraging wearable, clinical-grade gait sensors and a hardware control unit containing adaptive algorithms and clinically optimized music, InTandem automates the key principles of effective RAS therapy, in combination with best practices for neurorehabilitation interventions: individualization, progression, and challenge. InTandem's unique integration of advanced hardware, software and best clinical practices enables patients to access this evidence-based intervention independently at home.
"InTandem's personalized approach, grounded in the neuroscience of RAS and neuroplasticity, positions InTandem as an effective clinical intervention for chronic stroke patients seeking to improve their walking ability and overall mobility," said Dr. Alexander Pantelyat, associate professor of neurology at the Johns Hopkins University School of Medicine.
"These CMS decisions are crucial developments in the path to provide access to this groundbreaking treatment to patients," said Jennifer Lavanture, MedRhythms' VP of business development and corporate strategy. "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."
The new code for InTandem will become effective Oct. 1, 2024.
InTandem, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2020 and was listed as a Class II medical device in July 2023, is designed to be used by people with chronic stroke gait impairment. Results of a multi-site randomized controlled trial that demonstrated the clinical benefits and safety of InTandem were published in Nature Communications earlier this year.
InTandem Indication & Intended Use
InTandem is indicated to improve walking and ambulation in chronic stroke, and is intended to be used in the home for the physical rehabilitation of ambulatory adults. For full prescriber information, including important safety information and Instructions for Use (IFU) visit intandemrx.com.
