Deep brain stimulation involves the stereotactic placement of an electrode in the brain for the treatment of certain disorders associated with Parkinson's syndrome. The Food and Drug Administration (FDA) has approved the Medtronic ActivaTM Tremor Control Therapy device for unilateral thalamic stimulation for the suppression of tremor in the upper extremity for patients who are diagnosed with essential tremor or Parkinsonian tremor not controlled by medication and where the tremor constitutes a significant functional disability. Subsequently, bilateral stimulation in the subthalamic nucleus has been used for multiple symptoms of Parkinson's disease.
Currently, FDA is reviewing the safety and effectiveness of the bilateral use of this device in the subthalamic nucleus. Section 35-20 of the Medicare Coverage Issues (CIM) Manual states that "Medicare coverage of deep brain stimulation by implantation of a stimulator device is not prohibited. Therefore, coverage of deep brain stimulation provided by an implanted deep brain stimulator is at the carrier's discretion."
Requestor has asked that CMS issue a national coverage decision for the bilateral use of this device in the subthalamic nucleus. CMS will review the scientific evidence and determine if this procedure would be a reasonable and necessary service for Medicare beneficiaries.