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Centers for Medicare & Medicaid Services

MEDCAC Meeting 6/12/2002 - Deep Brain Stimulation for Parkinson's Disease (Medical and Surgical Procedures Panel)

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.

Federal Register Notice

Agenda for June 12, 2002 Meeting

Baltimore Convention Center— Rooms 337-338

Alan M. Garber, MD, PhD, Chairperson
Steve Phurrough, MD, MPA, Acting Director, Coverage and Analysis Group
Michelle L. Atkinson, Executive Secretary


7:30 – 8:00 AM

Registration

8:00 – 8:05 AM

Opening Remarks
M. Atkinson / S. Phurrough, MD, MPA

8:05 – 8:20 AM

CMS Presentation
Perry Bridger, MHS

8:20 – 8:50 AM

Medtronic Presentation
Roy Bakay, MD
Erwin B. Montgomery, Jr., MD

8:50 – 9:20 AM

Blue Cross Blue Shield Presentation of the Technology Assessment
Joan Vatz, MD

9:20 – 9:35 AM

FDA Presentation
Celia Witten, MD, PhD

9:35 – 10:00 AM

Scheduled Public Comments (see speaker list)

Public attendees who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors.

10:00 – 10:15 AM

BREAK

10:15 AM - 12:00 PM

Open Panel Deliberations
Alan M. Garber, MD, PhD

Public Observers May Not Participate Except at the Specific Request of the Chairperson

*   *   *   *   *   *   *   *   *   *

12:00 – 1:00 PM

LUNCH

*   *   *   *   *   *   *   *   *   *

1:00 – 1:30 PM

Open Public Comments

Public Attendees who wish to address the panel will be given that opportunity

1:30 – 2:45 PM

Open Panel Deliberations
Alan M. Garber, MD, PhD

Public Observers May Not Participate Except at the Specific Request of the Chairperson

2:45 – 3:00 PM

CMS Announcements / Adjournment
Steve Phurrough, MD, MPA
Closing Remarks
Michelle L. Atkinson

3:00PM

ADJOURN

Minutes of June 12, 2002 Meeting

OPEN SESSION

Baltimore Convention Center
Baltimore, Maryland

Attendees

Alan M. Garber
Chairperson

Michelle Atkinson
Executive Secretary

Voting Members
Angus M. McBryde
Les J. Zendle
James P. Rathmell
Bruce Sigsbee

Temporary Voting Members
Kim J. Burchiel
Thomas V. Holohan

Guests
Kenneth Follett
William J. Weiner
Irene Litvan
S. Satya-Murti
Joan I. Samuelson

CMS Representative
Steve Phurrough

Wednesday, June 12, 2002, 8:35 a.m.

The Medical and Surgical Procedures Panel met on June 12, 2002, to discuss the use of deep brain stimulation for Parkinson’s disease and essential tremor. The meeting began with a reading of the conflict of interest statement, and the call to order.

CMS Presentation.   A CMS representative presented the Panel with an overview of Parkinson’s disease, the coverage requested, and a summary of the deep brain stimulation procedure and how it is implemented. He then presented the panel with the following questions to be voted on by them:

Is the evidence adequate to determine the clinical effectiveness of bilateral subthalamic nucleus deep-brain stimulation for a well-defined set of Medicare patients with Parkinson's disease? If the evidence is adequate, what is the size, if any, of the overall health effect of this intervention?

Is the evidence adequate to determine the clinical effectiveness of bilateral GPi DBS for a well-defined set of Medicare patients with Parkinson's disease? And if that evidence is adequate, what is the size, if any, of the overall health effect?

Is the evidence adequate to determine the clinical effectiveness of unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor for a well-defined set of Medicare patients with Parkinson's disease? And if the evidence is adequate, what is the size, if any, of the overall health effect?

He then explained to the panel the seven levels of effectiveness, as defined by the MCAC Executive Committee that would be used to define the size of the effect. The subsequent questions were also defined.

Requestor’s Statement.   Dr. Perry Cohen read the requestor’s statement from Dr. Barry Green.

Medtronic Presentation.    Three speakers from Medtronic made a presentation outlining the clinical evidence of Activa brain-stimulation therapy for the treatment of advanced Parkinson's disease and essential tremor.

Presentation of Blue Cross/Blue Shield Technology Assessment.    Dr. Joan Vatz presented a summary of the TEC assessment. She gave a history of Parkinson’s disease and an overview of the treatments for the disease. She summarized the studies reviewed by the TEC in their assessment. The TEC conclusion was that although no large prospective randomized studies of the effect of deep brain stimulation had been conducted, the published evidence is quite compelling, both because of the numbers of effectively treated patients and because of the consistency of the findings across the studies and the magnitude of the clinical improvement.

FDA Presentation.   The panel heard from a FDA representative, who explained the various methods by which FDA approval may be obtained, and the approvals given to deep brain stimulation.

Scheduled Public Comments.   The Panel heard from three scheduled speakers, Dr. David Charles, Ellen Jante on behalf of herself and her husband Dale, and Dr. Frederick Lenz.

Dr. Charles, speaking for the American Academy of Neurology, related the Academy’s opinion that deep-brain stimulation for the treatment of Parkinson's disease, particularly stimulation of the subthalamic nucleus, represents the most significant advance in the treatment of Parkinson's disease in almost 30 years.

Ms. Jante summarized the experiences shared by her and her husband in the time since he was diagnosed with Parkinson’s disease.

Dr. Lenz spoke about some of the technical requirements and skills needed to perform the treatment.

Open Panel Discussion.   The panel discussion began with the introduction of individual panel members.

A number of panelists expressed concern that the skill and training of practitioners may affect health outcomes; the CMS representative stated that these concerns would be noted if and when a coverage decision was made, and that CMS would have the entire panel meeting minutes available to them and could refer to those minutes both for any coverage decision and in terms of requiring certain criteria for people performing the procedure.

In response to a concern voiced by a panelist relative to the marketing of the procedures, the Medtronic representative stated that the decision to recommend treatment is reached through a team approach for the individual patient, and that any physician doing the procedure would be adequately trained.

A concern was raised about whether the patient population that would benefit from deep brain stimulation would be Medicare beneficiaries. After discussion, it was the consensus of the panel that although patients may not be 65 years of age when they have the need for the treatment, they would probably qualify for Medicare coverage by reason of their disability, and therefore, the proposed treatment would affect a well-defined segment of the Medicare population.

Open Public Comments.   Prior to moving into their final discussion and voting, the panel heard additional comments from one member of the public.

Final Panel Recommendations.   The panel voted on the following questions:

Is the evidence adequate to determine the clinical effectiveness of bilateral subthalamic nucleus deep-brain stimulation for a well-defined set of Medicare patients with Parkinson's disease? To this question, the Panel voted unanimously in the positive.

Following the vote, panelists commented that they felt that although level-one studies may not be available, the overall evidence was compelling to support deep brain stimulation as a treatment option.

Is the evidence adequate to determine the clinical effectiveness of bilateral GPi DBS for a well-defined set of Medicare patients with Parkinson's disease? To this question, the Panel voted unanimously in the positive.

Panelists indicated their reason for this vote was the same as for the first question.

Prior to voting on levels of effectiveness, the panel discussed the differences between “breakthrough technology” and “more effective.” Some panelists stated that in some ways this technology may have represented a breakthrough, as in a major advance in treatment, but it did not rise to the level of standard of care. They also felt that it had more than small effects, as in the definition of “more effective” provided by the Executive Committee.

Following this discussion, the panel voted unanimously to assign the intervention to a new category for effectiveness, falling between “breakthrough” and “more effective.” They voted in favor of a statement that it improves health outcomes by a substantial margin, as compared with established services or medical items, for subthalamic nucleus deep-brain stimulation for a well-defined set of Medicare patients with Parkinson's disease.

The panel also voted unanimously that the new intervention improves health outcomes by a substantial margin, as compared with established services or medical items, for bilateral GPi DBS for a well-defined set of Medicare patients with Parkinson's disease.

Some panel members stated that they had not been given a detailed enough summary of the evidence available to be able vote on the third question posed by CMS. Following this discussion, the panel voted on the following question:

Is the evidence adequate to determine the clinical effectiveness of unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor for a well-defined set of Medicare patients with Parkinson's disease? The panel voted with four in favor and two abstentions.

Following the vote, the two members who abstained stated they did not feel that an adequate summary of evidence had been presented to them to allow them, as non-neurologists, to reach a conclusion.

The panel voted four to zero, with two abstentions, that the new intervention improves health outcomes by a substantial margin, as compared with established services or medical items, for unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor for a well-defined set of Medicare patients with Parkinson's disease.

Discussion Questions.   The panel expressed the view that most of the discussion questions posed by CMS had been discussed during the entire meeting. There was further discussion concerning patient inclusion criteria, and the issue of early-onset versus late-onset Parkinson’s. The panel returned to the issue of provider qualifications and reiterated the consensus that although there should be some criteria, the MCAC panel was not the body to determine those criteria.

Closing Remarks.    Dr. Phurrough mentioned that these recommendations would be forwarded to the Executive Committee, which is now scheduled to meet on September 25, 2002.

Adjournment.   The meeting adjourned at 12:25 p.m.

I certify that I attended the meeting
of the Medical and Surgical Procedures Panel
on June 12, 2002, and that these minutes
accurately reflect what transpired.
_________________________________
Michelle Atkinson
Executive Secretary, CMS

I approve the minutes of this meeting
as recorded in this summary.
______________________________
Alan J. Garber, MD. PhD
Chairperson

Questions for the Medical and Surgical Procedures Panel of the Medicare Coverage Advisory Committee (MCAC)

Voting Questions

Is the evidence adequate to determine the clinical effectiveness of bilateral subthalamic nucleus (STN) deep brain stimulation (DBS) for a well-defined set of Medicare patients with Parkinson’s disease?

  • If the evidence is adequate, what is the size, if any, of the overall health effect of bilateral STN DBS for those patients? (See MCAC document “Recommendations for Evaluating Effectiveness” [PDF, 101KB] for categories of effectiveness).

Is the evidence adequate to determine the clinical effectiveness of bilateral internal globus pallidus (GPi) DBS for a well-defined set of Medicare patients with Parkinson’s disease?

  • If the evidence is adequate, what is the size, if any, of the overall health effect of bilateral GPi DBS for those patients? (See MCAC document “Recommendations for Evaluating Effectiveness” [PDF, 101KB] for categories of effectiveness).

Is the evidence adequate to determine the clinical effectiveness of unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor for a well-defined set of Medicare patients with Parkinson’s disease?

  • If the evidence is adequate, what is the size, if any, of the overall health effect of unilateral thalamic DBS for essential tremor and/or Parkinsonian tremor for those patients? (See MCAC document “Recommendations for Evaluating Effectiveness” [PDF, 101KB] for categories of effectiveness).

Discussion Questions

Available clinical evidence evaluates bilateral STN or Gpi DBS in early onset Parkinson’s disease patients. Can these results be generalized to late onset advanced Parkinson's disease patients?

For coverage purposes, should Medicare patients be considered candidates for unilateral thalamic or bilateral STN or GPi DBS only if their characteristics closely match those of the patients included in the available studies?

DBS in the clinical literature is performed by highly trained providers at experienced facilities. Should facility and provider criteria to perform DBS in Medicare patients be part of any positive coverage decision?

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