This document addresses the use of deep brain, cortical, and cerebellar stimulation. These technologies involve the use of electrical stimulation of a specific site on or within the brain via implanted unilateral or bilateral electrodes that are connected to a pulse generator. For deep brain stimulation (DBS) and cerebral stimulation, the generator may be implanted in the chest. For cortical stimulation, the generator may be implanted in the head. These forms of electrical stimulation are used in the treatment of intractable movement disorders characterized by involuntary tremors or muscle contractions as well as for seizure and other neurological disorders.

Position Statement

Medically Necessary:

Parkinson’s disease

Unilateral or bilateral deep brain stimulation is considered medically necessary for individuals with Parkinson’s disease when the following criteria have been met:

1. A minimal score of 30 points on the motor portion of the Unified Parkinson’s Disease Rating Scale (UPDRS) when the individual has been without medication for 12 hours; and
2. Either of the following:
   1. Motor complications of therapy that cannot be controlled pharmacologically; or
   2. Tremor from Parkinson’s disease cannot be controlled pharmacologically.

Essential tremor

Unilateral or bilateral deep brain stimulation is considered medically necessary for individuals with medically refractory essential tremor.

Primary dystonia

Unilateral or bilateral deep brain stimulation is considered medically necessary for individuals with primary dystonia when the following criteria have been met:

1. 7 years of age or older; and
2. Stimulated area is the subthalamic nucleus or globus pallidus; and
3. Dystonia is all of the following:
   1. Chronic; and
   2. Cannot be controlled pharmacologically; and
   3. Has a significant effect upon daily activity; and
   4. Not due to a secondary cause such as stroke, cerebral palsy, tumor, trauma, infection, multiple sclerosis, other neurodegenerative diseases, or medications.

Obsessive Compulsive Disorder

Bilateral deep brain stimulation is considered medically necessary for individuals with obsessive compulsive disorder when the following criteria have been met:

1. 18 years of age or older; and
2. Stimulated area is the striatal axis; and
3. Well documented obsessive compulsive disorder for 5 years or longer; and
4. Severe functional impairment as indicated by a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score of 26 or greater despite conservative therapy meeting criteria 1 and 2 below:
   1. Cognitive-behavioral therapy with a minimum of 20 sessions involving personal (in-person or videoconference) interaction between the individual and a certified behavioral specialist; and
   2. Pharmacotherapy including both a and b below:
      1. A trial of clomipramine and at least two other serotonin-reuptake inhibitors at the maximum recommended dose or tolerated dose for at least 12 weeks; and
      2. Augmentation of at least one serotonin-reuptake inhibitor trial with first- or second-generation neuroleptic over a period of at least 1 month; and
5. Documentation indicates the individual or caregiver will be able to manage device in post-operative period; and
6. Absence of all of the following:
   1. Contraindication to surgery including, but not limited to, any of the following:
      1. Significant neurological condition (for example, history of stroke, hypoxic brain injury, severe head trauma, cranial neoplasm, movement disorder); or
      2. Contraindication and/or inability to undergo MRI; or
      3. Clinically significant abnormality on MRI that may impair deep brain stimulator implantation; or
      4. Clinically significant medical condition;
         and
   2. Current significant psychological condition including, but not limited to, any of the following:
      1. Active substance use disorder within the past 6 months; or
      2. Manic episode in the preceding 3 years; or
      3. Psychotic disorder within the past 3 years; or
      4. Imminent risk of suicide; or
      5. Severe personality disorder.

Epilepsy

Unilateral or bilateral deep brain stimulation is considered medically necessary for individuals with epilepsy when the following criteria have been met:

1. 18 years of age or older; and
2. Stimulated area is the anterior nucleus of the thalamus; and
3. Focal partial onset seizures with or without generalized seizure; and
4. Refractory to two (2) or more antiepileptic medications; and
5. Currently having an average of three (3) or more disabling seizures (for example, motor partial seizures, complex partial seizures, or secondary generalized seizures) per month over the most recent three months; and
6. Absence of progressive neurological or medical conditions such as brain tumors or neurodegenerative disease; and
7. Non-epileptic seizures have been ruled out as the sole seizure etiology.

Cortical stimulation is considered medically necessary for individuals with epilepsy when the following criteria have been met:

1. 18 years of age or older; and
2. Partial onset seizures; and
3. Diagnostic testing has localized no more than two (2) epileptogenic foci; and
4. Refractory to two (2) or more antiepileptic medications; and
5. Currently having an average of three (3) or more disabling seizures (for example, motor partial seizures, complex partial seizures, or secondary generalized seizures) per month over the most recent three months.

Revision or replacement

Revision or replacement of a deep brain stimulator, cortical stimulator, or battery for such devices is considered medically necessary when the following criteria are met:

1. The individual has demonstrated clinical benefit from the stimulation; and
2. One or both of the following criteria are met:
   1. The device has malfunctioned or is no longer working as intended; or
   2. The neurostimulator or battery is within 12 months of its expected maximum service life.

Investigational and Not Medically Necessary:

Deep brain stimulation is considered investigational and not medically necessary when criteria above have not been met.

The use of cortical stimulation is considered investigational and not medically necessary when the criteria above have not been met.

Revision or replacement of a deep brain stimulator, cortical stimulator, or battery for such devices is considered investigational and not medically necessary when the criteria above have not been met.

The use of cerebellar stimulation/pacing is considered investigational and not medically necessary.