Patients with RLS often suffer from severe sleep disruption, mental health issues, and reduced quality of life. Credit: Andrey_Popov / Shutterstock.

The Centers for Medicare & Medicaid Services (CMS) has granted new reimbursement codes and payment for Noctrix Health’s Nidra Tonic Motor Activation (TOMAC) system, a non-pharmaceutical treatment for Restless Legs Syndrome (RLS).

The system is designed to deliver electrical stimulation to the peroneal nerves through a pair of leg-worn devices.

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This latest move is set to improve access to the first Food and Drug Administration (FDA)-cleared wearable medical device for RLS symptoms, potentially benefiting millions of patients.

The Nidra TOMAC therapy, which received FDA marketing authorisation as a breakthrough device in the US last year, is the sole clinically validated option for RLS patients.

The CMS’ move to issue new codes for Nidra addresses the substantial need for alternative treatments, particularly for those who do not benefit from existing pharmaceutical options.

Noctrix Health president and CEO Shri Raghunathan said: “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 RLS.”

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The two new CMS reimbursement codes, E0743 for the devices and A4544 for the supplies, along with the associated payments, will take effect from 1 October 2024.

This development will enable healthcare providers to offer this treatment to eligible patients more widely.

Patients with RLS often suffer from severe sleep disruption, mental health issues, and reduced quality of life due to the lack of effective treatment alternatives.

Noctrix Health Patient Access senior vice-president Justin Kelly said: “The CMS decision to provide dedicated codes E0743 and A4544 for Nidra TOMAC therapy and supplies is a crucial development in expanding patient access to this groundbreaking treatment.”

The company recognises the critical need for accessible treatments and views the CMS decision as a significant step towards meeting this need.