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An expert
panel is preparing to recommend that Medicare provide coverage
for brain stimulation to treat advanced stages of Parkinson's
disease and essential tremor.
The Medical
and Surgical Procedures Panel of the Medicare Coverage Advisory
Committee (MCAC) overwhelmingly affirmed the effectiveness
of Activa® Therapy brain stimulation to relieve symptoms
of Parkinson's disease and essential tremor when medication
alone fails to provide adequate relief or consistently causes
intolerable side effects.
"The
panel's affirmation validates a growing accumulation of effectiveness
data and, equally as important, the experience of thousands
of patients whose motor function and overall lives have been
dramatically improved through treatment with brain stimulation,"
said Dr. Erwin B. Montgomery, a movement disorders neurologist
and co-director of the Cleveland Clinic Foundation's Functional
and Restorative Neuroscience Center.
"National
Medicare coverage and adequate reimbursement are critical
next steps in assuring access to this treatment for the thousands
more patients who stand to benefit from it," he said.
In a presentation
to the MCAC panel, Montgomery noted key findings of a global
clinical study of brain stimulation for advanced Parkinson's
disease symptoms after one year of treatment:
- 87
percent of patients had improved motor function without
the benefit of medication; and
- Patients
gained an average of an additional six hours of good motor
function each day.
MCAC's
executive committee will meet on September 25, 2002 to ratify
its expert panel's recommendation. Following receipt of the
executive committee's recommendation, the Centers for Medicare
and Medicaid Services will make their decision whether to
establish a national Medicare coverage policy for the brain
stimulation therapy. If approved, the policy will likely be
in effect within six to nine months of the decision.
Activa
Parkinson's Control Therapy, developed by Medtronic, Inc.,
received U.S. Food and Drug Administration approval in January
2002 for reduction of symptoms of advanced Parkinson's disease.
Source:
Medical Week staff,
week of June 16, 2002
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