CurrentPriority Health MedicarePolicy 91649

Tonic Motor Activation (ToMAc) Peroneal Nerve Stimulation for Restless Leg Syndrome (i.e., Nidra™) – Medicare Advantage

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This Medicare-only medical policy governs coverage consideration for tonic motor activation (ToMAc) peroneal nerve stimulation, including Nidra™, for adults with medication-refractory restless legs syndrome. Coverage is subject to the member's plan benefits and requires satisfaction of all stated medical necessity criteria.

Policy Summary

PayerPriority Health Medicare

PolicyToMAc Peroneal Nerve Stimulation for Restless Legs Syndrome

Policy CodePolicy N/A

Change TypeEligibility criteria revised

Effective Date09/01/2026

Next Review DateN/A

Key ActionDocument the member’s age, medication-refractory RLS history and failed medication(s), IRLS score, symptom frequency, symptom location, and symptom timing.

SourceLink

POLICY UPDATE CHANGES

The minimum eligible age was changed from 22–70 years to age 18 or older.

≥18 yearsMinimum member age

IRLS ≥15RLS severity threshold

≥2 nights/weekMinimum symptom frequency

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CurrentPriority Health MedicarePolicy 91649

Tonic Motor Activation (ToMAc) Peroneal Nerve Stimulation for Restless Leg Syndrome (i.e., Nidra™) – Medicare Advantage

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Policy Summary

PayerPriority Health Medicare

PolicyToMAc Peroneal Nerve Stimulation for Restless Legs Syndrome

Policy CodePolicy N/A

Change TypeEligibility criteria revised

Effective Date09/01/2026

Next Review DateN/A

Key ActionDocument the member’s age, medication-refractory RLS history and failed medication(s), IRLS score, symptom frequency, symptom location, and symptom timing.

SourceLink

POLICY UPDATE CHANGES

The minimum eligible age was changed from 22–70 years to age 18 or older.

≥18 yearsMinimum member age

IRLS ≥15RLS severity threshold

≥2 nights/weekMinimum symptom frequency

Medical Necessity Criteria

Medical necessity criteria for ToMAc in RLS

ToMAc peroneal nerve stimulation for restless legs syndrome may be considered medically necessary when all of the following criteria are met:

Initial ToMAc therapy for RLS

Adult member: Member is an adult age 18 years or older.≥18 years
Medication-refractory RLS: Member has failed one or more medications commonly prescribed to treat RLS, including ropinirole, pramipexole, gabapentin, pregabalin, gabapentin enacarbil, and/or rotigotine, for at least one qualifying reason.
Qualifying reasons are intolerable adverse effects, symptoms of augmentation, up-titration needed due to reduced efficacy, or insufficient response at the maximum approved, recommended, or tolerated dosage.
Disease severity: Member has moderate-to-severe primary RLS.IRLS total score ≥15
Symptom frequency: RLS symptoms occur at least two nights per week.≥2 nights per week
Symptom location: Symptoms are most significant in the lower legs and/or feet.
Symptom timing: Symptoms are most significant at bedtime, after bedtime, and/or during the two hours before bedtime.Within 2 hours before bedtime, at bedtime, and/or after bedtime

Coding and Clinical Thresholds

CodingHCPCS

E0743	External lower extremity nerve stimulator for restless legs syndrome
A4544	Electrode for external lower extremity nerve stimulator for restless legs syndrome

International RLS Study Group Rating Scale

MeasureInternational RLS Study Group Rating Scale (IRLS) total score

Required scoreAt least 15 (IRLS ≥15)

Applies toModerate-to-severe primary restless legs syndrome

Symptom frequency

Symptom frequencyAt least 2 nights per week

Required frequencySymptoms must occur ≥2 nights per week

Applies toRestless legs syndrome symptoms considered for ToMAc therapy

Documentation and Coverage Considerations

Documentation Required

Document all eligibility criteria

Requests must demonstrate medical necessity. Document the member’s age, medication-refractory RLS history and failed medication(s), IRLS score, symptom frequency, symptom location, and symptom timing.

Age ≥18 years
Failed one or more commonly prescribed RLS medications, including ropinirole, pramipexole, gabapentin, pregabalin, gabapentin enacarbil, and/or rotigotine
Reason for medication failure: intolerable adverse effects, augmentation symptoms, reduced efficacy requiring up-titration, or insufficient response at the maximum approved, recommended, or tolerated dosage
IRLS total score ≥15
Symptoms occurring ≥2 nights per week
Symptoms most significant in the lower legs and/or feet
Symptoms most significant at bedtime, after bedtime, and/or within the 2 hours before bedtime

Policy Background

This Medicare-only medical policy addresses tonic motor activation (ToMAc) peroneal nerve stimulation, including Nidra™, for adults with medication-refractory restless legs syndrome (RLS). Coverage consideration applies to primary RLS that is moderate to severe, occurs at least 2 nights per week, is most significant in the lower legs and/or feet, and occurs around bedtime.

Key Definitions

Medication-refractory RLS

DefinitionRLS is medication-refractory when one or more medications commonly prescribed to treat RLS have failed

MedicationsRopinirole, pramipexole, gabapentin, pregabalin, gabapentin enacarbil, and/or rotigotine

Qualifying failure reasonsIntolerable adverse effects; symptoms of augmentation; need for up-titration due to reduced efficacy; or insufficient response at the maximum approved, recommended, or tolerated dosage

Moderate-to-severe primary RLS

ConditionModerate-to-severe primary restless legs syndrome

AssessmentInternational RLS Study Group Rating Scale (IRLS) total score