Summary: Noctrix Health announced that the Centers for Medicare & Medicaid Services (CMS) has established new reimbursement codes for its FDA-cleared Nidra Tonic Motor Activation (TOMAC) system, a wearable device designed to treat restless legs syndrome (RLS). The new codes become effective Oct 1. The system works by delivering electrical stimulation to the peroneal nerves to alleviate RLS symptoms.
Key Takeaways:
- CMS Reimbursement Approval: CMS has introduced new reimbursement codes for the Nidra TOMAC system, with the codes becoming effective on Oct 1.
- FDA-Cleared and Clinically Validated: The Nidra TOMAC system is an FDA-cleared, clinically validated, non-pharmaceutical treatment available for RLS, delivering electrical stimulation via leg-worn devices.
- Impact on Patient Care: The CMS decision is expected to improve access to the treatment, offering an alternative to pharmaceutical options.
Noctrix Health announced that the Centers for Medicare & Medicaid Services (CMS) has established new reimbursement codes and payment for the company’s flagship product, the Nidra Tonic Motor Activation (TOMAC) system, a US Food and Drug Administration (FDA)-cleared wearable medical device to treat symptoms of restless legs syndrome (RLS).
The two new CMS reimbursement codes (E0743 for the devices and A4544 for the supplies) along with the associated payments will become effective on Oct 1.
The Nidra TOMAC System delivers electrical stimulation to the peroneal nerves via a pair of leg-worn devices. It was authorized for marketing in the United States last year following its designation as a Breakthrough Device by the FDA and remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS.
“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,” says Shri Raghunathan, president and CEO of Noctrix Health, in a release. “We are incredibly grateful for this recognition by CMS, which not only validates the innovative technology behind Nidra 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.”
Mark Buchfuhrer, MD, clinical associate professor at Stanford University and one of the principal investigators who was involved in the clinical studies that led to the FDA marketing authorization of TOMAC therapy, says in a release, “RLS is a condition that profoundly impacts the quality of life for millions of patients. The availability of a non-pharmaceutical option like Nidra, 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.”
Photo caption: Nidra Tonic Motor Activation (TOMAC) system
File photo
