Tonic Motor Activation (TOMAC) for Restless Legs Syndrome

POLICY NUMBER

A.1.01.32

DESCRIPTION

Restless Legs Syndrome

Restless legs syndrome (RLS) is a neurological condition characterized by an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations. These symptoms typically worsen during periods of rest or inactivity, especially in the evening or at night, and are temporarily relieved by movement. RLS is frequently associated with sleep disturbances and periodic limb movements during sleep (PLMS), which can further impair rest and daytime functioning. When PLMS occurs without RLS or other related disorders, it is classified as periodic limb movement disorder (PLMD). Treatment for RLS generally involves pharmacologic therapy, with options including alpha-2-delta calcium channel ligands, dopaminergic agents, opioids, and benzodiazepines. Therapy is tailored based on symptom severity, patient age, comorbidities, and individual preferences, aiming to improve sleep quality and overall life functioning. Dopaminergic therapies have a known risk of augmentation.

For individuals with refractory RLS, where symptoms persist despite first-line treatments like gabapentinoids, alternative strategies are considered. These include combination pharmacotherapy using different drug classes, low-dose opioids, and a thorough review of iron levels, potential exacerbating substances, behavioral interventions, and bilateral peroneal nerve stimulation.

Tonic Motor Activation

Tonic motor activation (TOMAC), also known as bilateral peroneal nerve stimulation, is proposed to work by delivering bilateral high-frequency electrical stimulation to the common peroneal nerves located near the fibula in the lower legs. This stimulation activates the tibialis anterior muscle, producing sustained, low-level muscle contractions that mimic the effects of voluntary leg movements like walking or stretching, which are activities known to relieve RLS symptoms.

The proposed biological mechanism involves afferent feedback.1, The stimulation sends signals back to the central nervous system, which may help suppress the abnormal sensory signals that drive the urge to move the legs. By activating the same circuits used during natural movement, TOMAC may modulate spinal and supraspinal pathways involved in RLS pathophysiology. 

TOMAC differs from transcutaneous electrical nerve stimulation (TENS) devices. TOMAC targets the common peroneal nerve with a goal of tonic activation of motor pathways to mimic movement with high-frequency, sustained, bilateral stimulation. TENS targets superficial sensory nerves often with the goal of pain relief by administering pulsed, often intermittent, stimulation.

Clinical Pathway

TOMAC is not a first-line therapy for RLS. It is indicated for moderate-to-severe primary RLS that is refractory to pharmacologic treatment. First-line therapies include, iron supplementation, gabapentinoids, lifestyle modifications (eg, regular moderate exercise, sleep habits, etc.).

Regulatory Status

The NTX100 Tonic Motor Activation (TOMAC) System (Noctrix Health, Inc; Pleasanton, CA) received De Novo classification (DEN220059; Product Code: QWD) from the FDA for its intended use "to reduce symptoms of primary moderate-severe Restless Legs Syndrome (RLS) and to improve sleep quality in adults refractory to medication."

POLICY

Tonic motor activation as a treatment for restless legs syndrome refractory to medication is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary.

For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

12/01/2025: New policy added. Approved by the Medical Policy Advisory Committee.

SOURCE(S)

Blue Cross Blue Shield Association policy # 1.01.32

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes        

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