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PARKINSN Home

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PARKINSN  February 2003, Week 1

PARKINSN February 2003, Week 1

Subject:

National Medicare coverage for DBS closer

From:

Linda J Herman <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Thu, 6 Feb 2003 17:44:13 -0500

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (223 lines)

Good news! But what the article below fails to mention is that the long
process towards a national coverage decision was initiated by Barry
Green, a PWP from Texas. He first filed a  request for national coverage
with CMS, the federal Medicare agency ,in  Oct. 2001

Today CMS issued a "decision memorandum" on DBS. Nationwide medicare
Coverage is not effective yet, but we're getting closer. Thank you
Barry!!

FROM: CMS
 "This decision memorandum does not constitute a national coverage
determination (NCD). It states CMS's intent to issue an NCD. Prior to any
new or modified policy taking effect, CMS must first issue a manual
instruction, program memorandum, CMS ruling or Federal Register Notice,
giving specific directions to our claims-processing contractors. That
issuance, which includes an effective date, is the NCD. If appropriate,
the Agency must also change billing and claims processing systems and
issue related instructions to allow for payment. The NCD will be
published in the Medicare Coverage Issues Manual. Policy changes become
effective as of the date listed in the transmittal that announces the
Coverage Issues Manual revision.

The whole story is at:
http://www.cms.hhs.gov/ncdr/trackingsheet.asp?id=21

Also the following press release from Medtronic:

 FROM: Business Wire
 February 6, 2003, Thursday 10:22 AM Eastern Time

HEADLINE: Medicare Opts to Cover Brain Stimulation Nationwide for
Parkinson's
 and Tremor

DATELINE: MINNEAPOLIS, Feb. 6, 2003

Agency's decision expands access to Medtronic's Activa(R) Therapy to
 thousands more Americans

  " In a move that will expand access nationwide to a breakthrough
treatment for
 advanced stages of Parkinson's disease and Essential Tremor, the federal
Centers
 for Medicare and Medicaid Services (CMS) today established a national
Medicare
 coverage policy for Activa(R) Therapy, or brain stimulation, from
Medtronic,
 Inc. (NYSE:MDT). When the new policy is fully implemented, every
Medicare
 beneficiary who needs or stands to benefit from brain stimulation will
be
 covered.

   Activa Therapy uses Medtronic's "brain pacemaker" technology to
control the
 disabling symptoms of the two most common neurological movement
disorders. Most
 private insurers already cover the treatment, and more are expected to
follow
 suit in the wake of CMS's decision to provide national Medicare
coverage.

   Combined, Parkinson's disease and Essential Tremor affect 2.5 million
 Americans. CMS (formerly the Health Care Financing Administration, or
HCFA) is
 the government agency that administers the healthcare programs covering
an
 estimated 75 million Americans.

   Activa Therapy has become the treatment of choice for Parkinson's
disease and
 Essential Tremor when medication alone fails to provide adequate benefit
or
 consistently causes intolerable side effects, according to Dr. Roy
Bakay,
 director of functional and restorative neurosurgery at the Chicago
Institute of
 Neurosurgery and Neuroresearch (CINN), and professor and vice chairman
of
 neurological surgery at Rush-Presbyterian-St. Luke's Medical Center in
Chicago.

   A pioneer in the treatment of neurological movement disorders and an
advocate
 of expanding coverage for proven applications of brain stimulation, Dr.
Bakay
 summarized the significance of the CMS decision:

   "No matter where they live, people on Medicare with Parkinson's or
tremor
 will have equal access to Activa Therapy. No longer will some patients
be denied
 this emerging standard of care because of coverage issues."

   "For now," he said, "in the absence of a cure, brain stimulation
represents
 the best option for many people whose lives have become severely
compromised by
 these devastating disorders. Importantly, it keeps patients' options
open for
 the future while providing symptom relief now."

   Added Scott Ward, president of Medtronic's Neurological and Diabetes
 business: "The agency's decision marks another milestone in the
development of
 this proven treatment for people in advanced stages of Parkinson's or
Essential
 Tremor. With national coverage for brain stimulation, Medicare
beneficiaries
 everywhere nationwide will have clear access to Activa Therapy."

   Activa Therapy works by stimulating deep brain structures that
influence
 motor control -- effectively blocking abnormal brain signals that cause
 disabling symptoms. The treatment can be adjusted noninvasively by a
clinician
 with a special programmer, and its effects can be reversed by turning
off the
 stimulation or removing the device. Similar in size to a cardiac
pacemaker and
 implanted near the collarbone, a medical device generically called a
 neurostimulator, or "brain pacemaker," generates precisely controlled
electrical
 pulses that are delivered to the brain through electrodes attached to a
thin
 wire.

   Studies show that Activa Therapy can dramatically improve mobility and
 movement control in properly selected patients. According to an article
 published in the Sept. 27, 2001 issue of the New England Journal of
Medicine,
 brain stimulation "is associated with significant improvement in motor
function
 in patients with Parkinson's disease whose condition cannot be improved
with
 medical therapy." The article presents data collected in Medtronic's
global
 multicenter clinical trials, which led to the U.S. Food and Drug
Adminstration's
 approval for brain stimulation as a treatment for Parkinson's in
January.

   Brain stimulation has been studied for more than two decades. Data
supporting
 its safety and efficacy have been published in dozens of peer-reviewed
medical
 journals and presented at hundreds of scientific meetings for
neurologists,
 neurosurgeons and neuroscientists. Designating brain stimulation
"substantially
 more effective" than the alternatives, an expert panel charged by CMS to
review
 the data in June declared unanimously in an official motion: "The new
 intervention improves health outcomes by a substantial margin, as
compared to
 established services or medical items."

   In the trials sponsored by Medtronic, Activa Therapy for advanced
Parkinson's
 disease increased "on" time -- periods of good motor function and
symptom relief
 -- by an average of more than six hours per day at 12 months in patients
whose
 data were verified against medical records. This dramatic improvement
occurred
 while dyskinesia -- the uncontrollable, involuntary movements that often
result
 from anti-Parkinsonian medications -- decreased significantly.

   The total cost of Activa Therapy ranges on average from $25,000
to$30,000 per
 side for the device and the associated physician and hospital fees,
which vary.
 Most private payors, and imminently Medicare, cover the vast majority of
the
 cost.

   Parkinson's disease and Essential Tremor are the two most common
neurological
 movement disorders. Parkinson's disease afflicts approximately 1 million
 Americans; Essential Tremor, about 1.5 million. Tremor is a common
symptom of
 both conditions, but Parkinson's also causes rigidity, slowness of
movement and
 poor balance. Both can lead to significant disability and loss of
independence.

   Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is
the
 world's leading medical technology company, providing lifelong solutions
for
 people with chronic disease. More information about Activa Therapy is
available
 online at www.newhopeforparkinsons.com.

   Any statements made about the company's anticipated financial results
and
 regulatory approvals are forward-looking statements subject to risks and
 uncertainties such as those described in Medtronic's Annual Report on
Form 10-K
 for the year ended April 26, 2002. Actual results may differ materially
from
 anticipated results.

   Note to Editors: Additional information and graphics related to Activa
 Therapy are available online at www.activapresspage.com.

   CONTACT: Medtronic, Inc., Minneapolis
 Media:
 Joe McGrath, 763/505-2634
 [log in to unmask]
 or
 Investors:
 Kevin Lee, 763/505-2695
 [log in to unmask]

   URL: http://www.businesswire.com

LOAD-DATE: February 6, 2003

----------------------------------------------------------------------
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In the body of the message put: signoff parkinsn

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January 2003, Week 5
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December 2002, Week 5
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December 2000, Week 5
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December 1997, Week 5
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December 1995, Week 5
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