Deep brain stimulation (DBS) involves the stereotactic placement of an electrode into a central nervous system nucleus (e.g., hypothalamus, thalamus, globus pallidus, subthalamic nucleus). DBS can be used as an alternative to permanent neuroablative procedures for control of essential tremor, Parkinson disease (PD), dystonia, obsessive compulsive disorder (OCD), and epilepsy.

Unilateral or bilateral DBS of the thalamic ventralis intermedius nucleus (VIM) may be considered medically necessary for the treatment of intractable tremors due to essential tremor or PD when ALL of the following criteria are met:

• Diagnosis of essential tremor or idiopathic PD (with the presence of at least two (2) cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
• No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V PD; and
• No focal lesion of the basal ganglia (e.g., a space occupying lesion or lacunae) at the target site that would negate the result of thalamic stimulation; and
• Sufficient residual motor function in the upper extremity so that it is reasonable to expect an improvement following the surgery; and
• Willingness and ability of the individual to cooperate during a conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Unilateral or bilateral DBS of the subthalamic nucleus (STN) or globus pallidus interna (GPi) for the treatment of PD may be considered medically necessary when ALL of the following criteria are met:

• PD of at least four (4) years duration; and
• PD (with the presence of at least two (2) cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
• Presence of disabling PD symptoms or medication side effects (e.g., dyskinesia’s, motor fluctuations, or disabling "off" periods) despite optimal medical therapy; and
• No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V PD; and
• PD is levodopa responsive with clearly defined "on" periods; and
• Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

DBS may be considered medically necessary when it is used as a treatment for chronic intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in individuals seven (7) years of age or older.

Intensive electronic analysis and programming of a deep brain stimulator may be necessary immediately following implantation to achieve optimal stimulus parameters. Recognizing these needs, six (6) such programming visits will be covered within 60 days of the surgical implantation of the deep brain stimulator, and once every 30 days thereafter, as necessary.

DBS is considered experimental/investigational and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature when used in ANY ONE of the following situations:

• For other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia; or
• For treatment of tremor from other causes such as trauma, degenerative disorders, metabolic disorders, or infectious diseases; or
• For other indications, including cluster headaches, refractory depression, and Tourette's syndrome.

Bilateral stimulation of the anterior nucleus of the thalamus may be considered medically necessary when ALL of the following criteria have been met:

• Age 18 years and older; and
• Individuals with partial onset seizures with or without secondary generalization to tonic-clonic activity; and
• Individuals with no response to three (3) or more antiepileptic medications; and
• The individual has an average of six (6) or more seizures per month, over the three (3) most recent months prior to DBS implantation (with no more than 30 days in between seizures).
  • Note: DBS has not been evaluated in individuals with less frequent seizures.

Bilateral stimulation of the anterior nucleus of the thalamus not meeting the criteria as indicated in this policy is considered not medically necessary.

Placement of fiducial markers to guide the implantation of deep brain stimulation electrodes is not to be coded separately for billing purposes, as this is an integral step to the placement of the leads. In instances when fiducial markers are placed on a separate date and/or location to when the electrodes are placed, they still cannot be billed separately.

United States Federal Food and Drug Administration (U.S. FDA)

Humanitarian Device Exemption (HDE)

DBS is U.S. FDA HDE approved for the indication of bilateral stimulation of the anterior limb of the internal capsule, aic, in obsessive compulsive disorder (OCD) when ALL of the following criteria have been met:

• Age 18 or older; and
• As an adjunct to medication(s); and
• As an alternative to anterior capsulotomy for the treatment of chronic, severe, treatment-resistant OCD; and
• For individuals that have failed at least three (3) or more selective serotonin reuptake inhibitors (SSRIs); and
• Approved by the institutional review board (IRB) or an appropriate local committee; and
  • Note: Appropriate local committee is defined by the U.S. FDA as a standing committee that has expertise and experience in reviewing and making treatment decisions for clinical care, particularly in applying innovative medical device technologies.
• Performed in a facility with IRB oversight.
  • Note: Documentation of IRB approval may be required to ensure compliance with HDE indications and applications.