Good news, but be aware it may still take over a year for the Medicare
coverage process to be completed and nationwide coverage to begin (see
below). The panel's recommendation is the first step - which began when
a request for a national Medicare coverage decision was filed by Barry
Green, a PWP from Texas, in Oct 2001.
SEE: www.grassrootsconnection.com for more info. on this issue
Medtronics Press release
FROM:
Business Wire
June 12, 2002, Wednesday 02:56 PM Eastern Time
SECTION: HEALTHWIRE
DISTRIBUTION: Business Editors & Health/Medical Writers
HEADLINE: Medicare Panel to Recommend National Coverage of Brain
Stimulation for
Parkinson's and Tremor; Clinical Data and Expert Testimony Highlight
Benefits of
Activa Therapy from Medtronic
DATELINE: BALTIMORE, June 12, 2002
The approximately 2.5 million Americans with Parkinson's disease or
Essential
Tremor received good news today as a Medicare panel prepares to recommend
national coverage for brain stimulation to treat advanced stages of the
two most
common neurological movement disorders.
After considering clinical data and expert testimony, the Medical and
Surgical Procedures Panel of the Medicare Coverage Advisory Committee
(MCAC)
overwhelmingly affirmed the effectiveness of Activa(R) Therapy, which
uses brain
stimulation technology developed by Medtronic, Inc. (NYSE:MDT) to relieve
symptoms of Parkinson's disease and Essential Tremor when medication
alone fails
to provide adequate benefit or consistently causes intolerable side
effects.
Based on the prevalence and progression of the diseases, as well as their
responsiveness to medication, Medtronic estimates that about 85,000
Parkinson's
patients and 5,000 Essential Tremor patients in the United States are
candidates
for treatment with Activa Therapy.
"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."
Dr. Montgomery addressed the MCAC panel with Dr. Roy Bakay, professor
of
neurological surgery at Rush-Presbyterian-St. Luke's Medical Center in
Chicago.
Their presentation 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, assessed without the benefit of medication,
demonstrated improved motor function
-- on average, patients gained an additional six hours of good motor
function
each day
Today's panel meeting at the Baltimore Convention Center also included
discussion of a technology assessment report on Activa Therapy prepared
by the
Blue Cross and Blue Shield Association. "The published scientific
evidence is
compelling because of the numbers of consecutively treated patients
described,
the consistency of the findings across studies, and the magnitude of
clinical
improvements observed on standardized rating scales of neurologic
function,"
according to the report by Dr. Joan B. Vatz, who reviewed results of 33
separate
studies for the assessment. "More recent evidence suggests that bilateral
deep-brain stimulation ... may alleviate ... parkinsonian symptoms
(tremor,
rigidity, and bradykinesia)."
MCAC's executive committee is scheduled to meet Sept. 25 to ratify its
expert
panel's recommendation. Following receipt of the executive committee's
recommendation, the Centers for Medicare and Medicaid Services (CMS) will
decide
within 60 days whether to establish a national Medicare coverage policy
for
Activa Therapy. CMS will then publish its decision online at
www.cms.hhs.gov/coverage/. If the decision is positive, CMS will issue a
national coverage decision within 60 days and begin to develop
implementation
instructions for its contractors (carriers and fiscal intermediaries).
These
instructions will provide details regarding coverage, coding and
reimbursement
levels. Typically, it requires seven to nine months from the date of the
national coverage decision for the policy to go into effect.
CMS (formerly the Health Care Financing Administration) is the
government
agency that administers Medicare and Medicaid, two bellwethers in health
insurance that, combined, cover an estimated 75 million Americans. All 52
Medicare jurisdictions now have written policies providing coverage for
Activa
Tremor Control Therapy, which stimulates the thalamus to suppress tremor.
But
less than half have written policies in place for Activa Parkinson's
Control
Therapy, which stimulates other structures -- namely, the subthalamic
nucleus
(STN) or the globus pallidus pars interna (GPi) -- to reduce the
typically more
debilitating symptoms of the disease, including stiffness and slowness. A
national coverage policy for Activa Therapy would eliminate the need for
individual action by the jurisdictions that do not have written policies
for
Activa Parkinson's Control Therapy.
Essential Tremor and Parkinson's disease are the two most common
neurological
movement disorders. Essential Tremor afflicts about 1.5 million
Americans;
Parkinson's disease, about 1 million. Tremor is a common symptom of both,
but
Parkinson's also causes rigidity, slowness of movement and poor balance.
Nearly 8,000 people in the United States have been treated with Activa
Therapy -- about 6,000 for symptoms of advanced Parkinson's disease and
another
2,000 for Essential Tremor. Activa Tremor Control Therapy received
approval from
the U.S. Food and Drug Administration (FDA) in August 1997 for unilateral
stimulation of the thalamus to suppress tremor on the opposite side of
the body.
Activa Parkinson's Control Therapy received FDA approval in January 2002
for
bilateral stimulation of the STN or GPi to reduce symptoms of advanced
Parkinson's disease. The cost of Activa Therapy ranges from $25,000
to$30,000
per side for the device and the associated physician and hospital fees.
Editor's Note: Additional information and graphics related to Activa
Therapy
are available online at www.activapresspage.com.
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