Is an external lower extremity nerve stimulator, specifically the NTX-100 Tonic Motor Activation System, medically necessary for a 38-year-old male patient with moderate to severe Restless Legs Syndrome (RLS) who is refractory to at least one medication, including pregabalin and buspar (buspirone)?

From the Guidelines

The external lower extremity nerve stimulator (specifically the NTX-100 Tonic Motor Activation System/TOMAC therapy) is not medically necessary for this patient with restless legs syndrome. The determination is based on insufficient evidence to establish the effectiveness of TOMAC systems for treating restless leg syndrome, as stated in the policy [CPB 0677@] which considers the TOMAC system for the treatment of restless leg syndrome as an intervention with insufficient evidence or unproven. While the patient has moderate to severe restless legs syndrome that has been refractory to at least one medication (pregabalin and buspar are mentioned as prior treatments), the TOMAC system is considered unproven therapy at this time [@1@, @2@]. The clinical evidence does not sufficiently demonstrate that this device provides meaningful improvement in symptoms or outcomes for patients with restless leg syndrome compared to standard medical therapies. Alternative treatment options that have better established evidence should be considered instead, such as:

• Dopamine agonists
• Anticonvulsants
• Iron supplementation if deficient, as suggested by the American Academy of Sleep Medicine clinical practice guideline [@1@]
• Bilateral high-frequency peroneal nerve stimulation, which receives a conditional recommendation from initial success in short-term sham-controlled studies and a longer observational extension [@2@] The patient should continue working with their physician to explore other evidence-based treatment options for managing their refractory restless legs syndrome symptoms. Key considerations for treatment include:
• Identifying potential side effects that could lead to discontinuation of therapy
• Exploring alternative approaches to pharmacological agents and their potential adverse systemic effects
• Considering the use of oral iron supplementation in cases of iron deficiency as a low-risk, accessible treatment that may address an underlying cause of the condition [@1@, @2

From the Research

Determination of Medical Necessity

The determination of medical necessity for an external lower extremity nerve stimulator for a patient with restless legs syndrome (RLS) is based on the patient's symptoms, medical history, and response to previous treatments.

• The patient is a 38-year-old male with moderate to severe RLS symptoms that have progressively increased over time, despite attempts at treatment with pregabalin and buspar 1, 2.
• The patient's symptoms have not been adequately controlled with medication, and the physician has recommended Tonic Motor Activation Therapy (TOMAC therapy) using the NTX-100 Tonic Motor Activation System to improve sleep quality and reduce RLS symptoms.
• The device is classified as a bilateral device, with one band for each leg, and the physician has determined that the patient meets the criteria for use of the device.

Rationale for Determination

The rationale for the determination of medical necessity is based on the following criteria:

• The patient has a diagnosis of moderate to severe RLS, as indicated by the International RLS Scale score and the presence of symptoms such as an urge to move the legs, relief upon movement, and worsened symptom severity at night 1, 2.
• The patient has tried conservative treatments, including pregabalin and buspar, and has not achieved adequate symptom control 3, 4.
• The patient is refractory to at least one medication, and the physician has determined that TOMAC therapy is a reasonable treatment option for the patient's RLS symptoms 5.
• The use of the NTX-100 Tonic Motor Activation System is supported by clinical evidence, including a study that demonstrated the efficacy of TOMAC therapy in reducing opioid dose and improving RLS symptoms in patients with refractory RLS 5.

Criteria for Use

The criteria for use of the external lower extremity nerve stimulator include:

• A diagnosis of moderate to severe RLS, as indicated by the International RLS Scale score and the presence of symptoms such as an urge to move the legs, relief upon movement, and worsened symptom severity at night 1, 2.
• Failure to achieve adequate symptom control with conservative treatments, including medication and lifestyle modifications 3, 4.
• Refractoriness to at least one medication, and a determination by the physician that TOMAC therapy is a reasonable treatment option for the patient's RLS symptoms 5.