CurrentRegence BlueCross BlueShieldPolicy 83.15

Tonic Motor Activation (TOMAC) for Restless Legs Syndrome

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This policy governs coverage of the TOMAC bilateral peroneal nerve stimulation device for treating restless legs syndrome. TOMAC treatment for restless legs syndrome is considered investigational and is not covered under this policy.

Policy Summary

PayerRegence BlueCross BlueShield

PolicyTonic Motor Activation (TOMAC) for Restless Legs Syndrome

Policy CodePolicy 83.15

Change TypeNo material change

Effective DateNovember 1, 2026

Last ReviewOct 1, 2026

Next Review DateJune 1, 2027

Key ActionRequests for TOMAC or bilateral peroneal nerve stimulation for restless legs syndrome are subject to denial because the therapy is considered investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalCoverage determination for TOMAC

3 RCTsRandomized controlled trials

252Pooled efficacy participants

45% vs 16%TOMAC vs sham responders

6 months

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CurrentRegence BlueCross BlueShieldPolicy 83.15

Tonic Motor Activation (TOMAC) for Restless Legs Syndrome

Customize your policy alerts

Sign up for regence Policy 83.15 alerts

Get alerted when Policy 83.15 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerRegence BlueCross BlueShield

PolicyTonic Motor Activation (TOMAC) for Restless Legs Syndrome

Policy CodePolicy 83.15

Change TypeNo material change

Effective DateNovember 1, 2026

Last ReviewOct 1, 2026

Next Review DateJune 1, 2027

Key ActionRequests for TOMAC or bilateral peroneal nerve stimulation for restless legs syndrome are subject to denial because the therapy is considered investigational.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalCoverage determination for TOMAC

3 RCTsRandomized controlled trials

252Pooled efficacy participants

45% vs 16%TOMAC vs sham responders

6 months

Coverage Determination

Investigational

TOMAC treatment for restless legs syndrome is considered investigational.

Investigational status: Tonic motor activation as a treatment for restless legs syndrome is considered investigational.

No covered medical-necessity pathway is specified.

Investigational for restless legs syndrome

TOMAC or bilateral peroneal nerve stimulation is considered investigational for restless legs syndrome.

Investigational status: There is not enough research to show that tonic motor activation (TOMAC) or bilateral peroneal nerve stimulation improves health outcomes for individuals with restless legs syndrome.

Additional randomized controlled trials comparing this therapy with standard treatment are needed.

Tonic motor activation used as a treatment for restless legs syndrome is excluded from coverage because it is considered investigational.

Coding Information

Regulatory identifiersmixed

DEN220059	FDA De Novo classification identifier for the NTX100 Tonic Motor Activation System
QWD	FDA product code for the NTX100 Tonic Motor Activation System

HCPCSHCPCSExperimental

A4544

Electrode for external lower extremity nerve stimulator for restless legs syndrome External lower extremity nerve stimulator for restless legs syndrome, each

Provider and Billing Actions

Denial Risk

Investigational treatment may be denied

Requests for tonic motor activation as a treatment for restless legs syndrome may be denied because the service is considered investigational.

Denial Risk

Investigational therapy subject to denial

Requests for tonic motor activation (TOMAC) or bilateral peroneal nerve stimulation for restless legs syndrome are subject to denial because the therapy is considered investigational and available research is insufficient to demonstrate improved health outcomes.

Clinical Background

Restless legs syndrome is a neurological condition characterized by an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations. Symptoms typically worsen during rest or inactivity and in the evening or at night, and are temporarily relieved by movement.

Definitions

Tonic motor activation (TOMAC)

DeviceA peroneal nerve stimulation device worn on the lower legs.

StimulationDelivers bilateral, high-frequency electrical stimulation to the common peroneal nerves.

Muscle responseProduces sustained, low-level muscle contractions that mimic voluntary leg movements such as walking or stretching.

Restless legs syndrome (RLS)

ConditionA neurological condition characterized by an uncontrollable urge to move the legs.

Associated sensationsOften accompanied by uncomfortable sensations.

Typical pattern

Medical Necessity Determination

TOMAC equipment is investigational

The equipment is considered investigational for restless legs syndrome.

Investigational DME: Available published evidence is insufficient to establish that TOMAC or bilateral peroneal nerve stimulation improves health outcomes for restless legs syndrome.

Additional randomized controlled trials comparing the therapy with standard treatment are needed.

Services Not Covered

Tonic motor activation (TOMAC) for restless legs syndrome is not covered because the treatment is considered investigational.