Noctrix Health announced that the Centers for Medicare & Medicaid Services (CMS) have established new reimbursement codes and payment for the company’s flagship product, the NidraTM Tonic Motor Activation system, the first FDA-cleared wearable medical device to treat symptoms of Restless Legs Syndrome (RLS). This milestone marks a pivotal moment in making this breakthrough therapy accessible to millions of patients suffering from debilitating symptoms of RLS, recognizing the critical need for accessible, non-pharmaceutical treatments.
Nidra TOMAC Tonic Motor Activation Therapy, which was authorized for marketing in the United States last year following its designation as a “Breakthrough Device” by the US Food & Drug Administration (FDA), remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS. The CMS decision to issue new codes for NidraTM underscores the recognition of this significant unmet need and facilitates access to this breakthrough therapy for millions of patients who do not respond to pharmaceutical treatments. These patients are left with no other approved or cleared treatment alternatives today and continue to suffer from the debilitating effects of sleep deprivation, poor mental health, and a significantly diminished quality of life.
“Receiving dedicated reimbursement codes from CMS is a monumental achievement for Noctrix Health and a testament to our commitment to improving the lives of patients with Restless Legs Syndrome,” said Shri Raghunathan, President & CEO of Noctrix Health. “We are incredibly grateful for this recognition by CMS, which not only validates the innovative technology behind NidraTM TOMAC therapy but also ensures that more patients will have access to this life-changing treatment. This milestone represents a significant step forward in our mission to provide effective, non-pharmaceutical solutions for those in need.”
Justin Kelly, Senior Vice President of Patient Access at Noctrix Health, added, “The CMS decision to provide dedicated codes E0743 and A4544 for NidraTM TOMAC therapy and supplies is a crucial development in expanding patient access to this groundbreaking treatment. Our team has worked tirelessly to advocate for the needs of RLS patients, and this recognition by CMS is a major victory for them. We look forward to working with healthcare providers and payers to ensure that patients across the country can benefit from this innovative therapy.”
Dr. Mark Buchfuhrer, MD, clinical associate professor at Stanford University and one of the principal investigators who was involved in the foundational clinical studies that led to the FDA marketing authorization of TOMAC therapy, emphasized the importance of this recognition: “RLS is a condition that profoundly impacts the quality of life for millions of patients. The availability of a non-pharmaceutical option like NidraTM, now supported by CMS reimbursement, is a game-changer in our treatment approach. This decision will allow more patients to receive effective care, leading to better outcomes and improved quality of life.”
The two new CMS reimbursement codes (E0743 for the devices and A4544 for the supplies) along with the associated payments will become effective on October 1, 2024, enabling more healthcare providers to offer this innovative treatment to eligible patients. Noctrix Health remains committed to advancing patient care and will continue to work closely with the medical