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National Coverage Analysis (NCA) Tracking Sheet

Deep Brain Stimulation for Parkinson's Disease

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Issue

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 Activa™ 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.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
Dr. Barry Green, Tyler, Texas N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
10/19/2001
Expected NCA Completion Date
02/06/2003
Public Comment Period
11/19/2001 - 12/19/2001
Proposed Decision Memo Due Date
10/19/2001
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
02/06/2003

Contacts

Lead Analysts
Perry Bridger, MHS
Michelle Atkinson
Lead Medical Officers
Lawrence Schott, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

October 19, 2001

CMS staff worked with requestor to complete formal request, including appropriate evidence, and formally accepted request today for review.

December 13, 2001

CMS requested that the Agency for Healthcare Research and Quality (AHRQ) purchase a technology assessment of bilateral deep brain stimulation of the subthalamic nucleus (STN) or the globus pallidus interna (Gpi) for treatment of advanced Parkinson's disease recently performed by the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). CMS expects to receive the finished technology assessment by the end of January 2002. After we receive the technology assessment, we will post it on our website for review. The new due date for the decision will be 60 days after receipt of the technology assessment.

January 7, 2001

CMS initially expanded its evaluation of the evidence to include bilateral deep brain stimulation of the GPi. After further consideration, we are now also evaluating unilateral thalamic stimulation for essential tremor and Parkinsonian tremor. Therefore, we are changing the title of this determination to "Deep Brain Stimulation for Parkinson's Disease."

February 4, 2002

Technology Assessment posted on website. The new due date for the decision will be April 5, 2002.

March 8, 2002

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.

April 26, 2002

Federal Register Notice published with further information regarding the MCAC Medical and Surgical Procedures Panel to be held on June 12, 2002.

June 3, 2002

Agenda for the June 12, 2002, meeting posted along with Summaries of studies of unilateral thalamic stimulation for essential tremor or Parkinsonian tremor reviewed by CMS staff.

June 7, 2002

Panel voting and discussion Questions for the June 12, 2002 meeting, posted.

July 9, 2002

Transcript of the June 12, 2002, MCAC Medical and Surgical Procedures Panel posted.

August 27, 2002

Federal Register Notice published with further information regarding the MCAC Executive Committee (EC) meeting to be held on September 25, 2002, in Baltimore, Maryland. The MCAC EC will act on recommendations from the Medical and Surgical Procedures Panel regarding the use of deep brain stimulation for the treatment of Parkinson's disease and essential tremor.

Minutes of the June 12, 2002 MCAC Medical and Surgical Procedures Panel posted.

November 4, 2002

Minutes and transcript of theSeptember 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.

February 6, 2003

February 14, 2003

Claims processing instructions issued and NCD updated
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