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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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2000, Week 2 April 2000, Week 1 March 2000, Week 5 March 2000, Week 4 March 2000, Week 3 March 2000, Week 2 March 2000, Week 1 February 2000, Week 5 February 2000, Week 4 February 2000, Week 3 February 2000, Week 2 February 2000, Week 1 January 2000, Week 5 January 2000, Week 4 January 2000, Week 3 January 2000, Week 2 January 2000, Week 1 December 1999, Week 5 December 1999, Week 4 December 1999, Week 3 December 1999, Week 2 December 1999, Week 1 November 1999, Week 5 November 1999, Week 4 November 1999, Week 3 November 1999, Week 2 November 1999, Week 1 October 1999, Week 5 October 1999, Week 4 October 1999, Week 3 October 1999, Week 2 October 1999, Week 1 September 1999, Week 5 September 1999, Week 4 September 1999, Week 3 September 1999, Week 2 September 1999, Week 1 August 1999, Week 5 August 1999, Week 4 August 1999, Week 3 August 1999, Week 2 August 1999, Week 1 July 1999, Week 5 July 1999, Week 4 July 1999, Week 3 July 1999, Week 2 July 1999, Week 1 June 1999, Week 5 June 1999, Week 4 June 1999, Week 3 June 1999, Week 2 June 1999, Week 1 May 1999, Week 5 May 1999, Week 4 May 1999, Week 3 May 1999, Week 2 May 1999, Week 1 April 1999, Week 5 April 1999, Week 4 April 1999, Week 3 April 1999, Week 2 April 1999, Week 1 March 1999, Week 5 March 1999, Week 4 March 1999, Week 3 March 1999, Week 2 March 1999, Week 1 February 1999, Week 4 February 1999, Week 3 February 1999, Week 2 February 1999, Week 1 January 1999, Week 5 January 1999, Week 4 January 1999, Week 3 January 1999, Week 2 January 1999, Week 1 December 1998, Week 5 December 1998, Week 4 December 1998, Week 3 December 1998, Week 2 December 1998, Week 1 November 1998, Week 5 November 1998, Week 4 November 1998, Week 3 November 1998, Week 2 November 1998, Week 1 October 1998, Week 5 October 1998, Week 4 October 1998, Week 3 October 1998, Week 2 October 1998, Week 1 September 1998, Week 5 September 1998, Week 4 September 1998, Week 3 September 1998, Week 2 September 1998, Week 1 August 1998, Week 5 August 1998, Week 4 August 1998, Week 3 August 1998, Week 2 August 1998, Week 1 July 1998, Week 5 July 1998, Week 4 July 1998, Week 3 July 1998, Week 2 July 1998, Week 1 June 1998, Week 5 June 1998, Week 4 June 1998, Week 3 June 1998, Week 2 June 1998, Week 1 May 1998, Week 5 May 1998, Week 4 May 1998, Week 3 May 1998, Week 2 May 1998, Week 1 April 1998, Week 5 April 1998, Week 4 April 1998, Week 3 April 1998, Week 2 April 1998, Week 1 March 1998, Week 5 March 1998, Week 4 March 1998, Week 3 March 1998, Week 2 March 1998, Week 1 February 1998, Week 5 February 1998, Week 4 February 1998, Week 3 February 1998, Week 2 February 1998, Week 1 January 1998, Week 5 January 1998, Week 4 January 1998, Week 3 January 1998, Week 2 January 1998, Week 1 December 1997, Week 5 December 1997, Week 4 December 1997, Week 3 December 1997, Week 2 December 1997, Week 1 November 1997, Week 5 November 1997, Week 4 November 1997, Week 3 November 1997, Week 2 November 1997, Week 1 October 1997, Week 5 October 1997, Week 4 October 1997, Week 3 October 1997, Week 2 October 1997, Week 1 September 1997, Week 5 September 1997, Week 4 September 1997, Week 3 September 1997, Week 2 September 1997, Week 1 August 1997, Week 5 August 1997, Week 4 August 1997, Week 3 August 1997, Week 2 August 1997, Week 1 July 1997, Week 5 July 1997, Week 4 July 1997, Week 3 July 1997, Week 2 July 1997, Week 1 June 1997, Week 5 June 1997, Week 4 June 1997, Week 3 June 1997, Week 2 June 1997, Week 1 May 1997, Week 5 May 1997, Week 4 May 1997, Week 3 May 1997, Week 2 May 1997, Week 1 April 1997, Week 5 April 1997, Week 4 April 1997, Week 3 April 1997, Week 2 April 1997, Week 1 March 1997, Week 5 March 1997, Week 4 March 1997, Week 3 March 1997, Week 2 March 1997, Week 1 February 1997, Week 5 February 1997, Week 4 February 1997, Week 3 February 1997, Week 2 February 1997, Week 1 January 1997, Week 5 January 1997, Week 4 January 1997, Week 3 January 1997, Week 2 January 1997, Week 1 December 1996, Week 5 December 1996, Week 4 December 1996, Week 3 December 1996, Week 2 December 1996, Week 1 November 1996, Week 5 November 1996, Week 4 November 1996, Week 3 November 1996, Week 2 November 1996, Week 1 October 1996, Week 5 October 1996, Week 4 October 1996, Week 3 October 1996, Week 2 October 1996, Week 1 September 1996, Week 5 September 1996, Week 4 September 1996, Week 3 September 1996, Week 2 September 1996, Week 1 August 1996, Week 5 August 1996, Week 4 August 1996, Week 3 August 1996, Week 2 August 1996, Week 1 July 1996, Week 5 July 1996, Week 4 July 1996, Week 3 July 1996, Week 2 July 1996, Week 1 June 1996, Week 5 June 1996, Week 4 June 1996, Week 3 June 1996, Week 2 June 1996, Week 1 May 1996, Week 5 May 1996, Week 4 May 1996, Week 3 May 1996, Week 2 May 1996, Week 1 April 1996, Week 5 April 1996, Week 4 April 1996, Week 3 April 1996, Week 2 April 1996, Week 1 March 1996, Week 5 March 1996, Week 4 March 1996, Week 3 March 1996, Week 2 March 1996, Week 1 February 1996, Week 5 February 1996, Week 4 February 1996, Week 3 February 1996, Week 2 February 1996, Week 1 January 1996, Week 5 January 1996, Week 4 January 1996, Week 3 January 1996, Week 2 January 1996, Week 1 December 1995, Week 5 December 1995, Week 4 December 1995, Week 3 December 1995, Week 2 December 1995, Week 1 November 1995, Week 5 November 1995, Week 4 November 1995, Week 3 November 1995, Week 2 November 1995, Week 1 October 1995, Week 5 October 1995, Week 4 October 1995, Week 3 October 1995, Week 2 October 1995, Week 1 September 1995, Week 5 September 1995, Week 4 September 1995, Week 3 September 1995, Week 2 September 1995, Week 1 August 1995, Week 5 August 1995, Week 4 August 1995, Week 3 August 1995, Week 2 August 1995, Week 1 July 1995, Week 5 July 1995, Week 4 July 1995, Week 3 July 1995, Week 2 July 1995, Week 1 June 1995, Week 5 June 1995, Week 4 June 1995, Week 3 June 1995, Week 2 June 1995, Week 1 May 1995, Week 5 May 1995, Week 4 May 1995, Week 3 May 1995, Week 2 May 1995, Week 1 April 1995, Week 5 April 1995, Week 4 April 1995, Week 3 April 1995, Week 2 April 1995, Week 1 March 1995, Week 5 March 1995, Week 4 March 1995, Week 3 March 1995, Week 2 March 1995, Week 1 February 1995, Week 4 February 1995, Week 3 February 1995, Week 2 February 1995, Week 1 January 1995, Week 5 January 1995, Week 4 January 1995, Week 3 January 1995, Week 2 January 1995, Week 1 December 1994, Week 5 December 1994, Week 4 December 1994, Week 3 December 1994, Week 2 December 1994, Week 1 November 1994, Week 5 November 1994, Week 4 November 1994, Week 3 November 1994, Week 2 November 1994, Week 1 October 1994, Week 5 October 1994, Week 4 October 1994, Week 3 October 1994, Week 2 October 1994, Week 1 September 1994, Week 5 September 1994, Week 4 September 1994, Week 3 September 1994, Week 2 September 1994, Week 1 August 1994, Week 5 August 1994, Week 4 August 1994, Week 3 August 1994, Week 2 August 1994, Week 1 July 1994, Week 5 July 1994, Week 4 July 1994, Week 3 July 1994, Week 2 July 1994, Week 1 June 1994, Week 5 June 1994, Week 4 June 1994, Week 3 June 1994, Week 2 June 1994, Week 1 May 1994, Week 5 May 1994, Week 4 May 1994, Week 3 May 1994, Week 2 May 1994, Week 1 April 1994, Week 5 April 1994, Week 4 April 1994, Week 3 April 1994, Week 2 April 1994, Week 1 March 1994, Week 5 March 1994, Week 4 March 1994, Week 3 March 1994, Week 2 March 1994, Week 1 February 1994, Week 4 February 1994, Week 3 February 1994, Week 2 February 1994, Week 1 February 1994 January 1994 December 1993 November 1993
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