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.
Issue referred to the MCAC Medical and Surgical Procedures Panel. This panel meeting will be held on June 12, 2002, in Baltimore, Maryland. Further details about this meeting will be announced on this website and in the Federal Register. The new due date for the decision will be 60 days following receipt of the formal MCAC recommendation.
NOTE: On January 14, 2002, the FDA approved the Medtronic® Activa® Parkinson's Control Therapy System for bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
Minutes and transcript of the September 25, 2002, MCAC EC Panel posted. The formal MCAC recommendation was received on November 1, 2002. Therefore, the new due date for the decision will be December 30, 2002.
This device was determined by the Center for Medicare Management to fall within the Prosthetic Device benefit category (section 1861 (s)(8) of the Social Security Act (the Act). The surgical implantation of the lead and pulse generator is performed by a physician and falls under section 1861(s)(1) of the Act, Physicians' Services.