“…there also may be secondary benefits Joyce and you are also accruing…”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, June 20, 2015 12:32 PM
Subject: Hacking the nervous system

To Joyce’s fellow VNS depression patients et al,

I truly hope this note finds you all doing well.

As you well know I have advocated fervently trying to help all those who have benefited and wish to continue with this depression therapy obtain health insurance coverage while also continuing my reading, research, collaborating and advocacy/activism.  I am aware VNS Therapy is still being studied for other medical illnesses as well.  Just today a very dear and long, long, long-time friend Murray shared with me an article that I’d also like to share with you.

While you may be benefiting for purposes of depression there also may be secondary benefits Joyce and you are also accruing unbeknownst to you.  Please take a moment to read the below listed link:

Hacking the nervous system

As always, I wish you all wellness and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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In all fairness and balanced reporting…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 11:46 PM
Subject: In all fairness and balanced reporting…

To Joyce’s fellow depression patients’ et al.:

As you know I have had through the year’s respectful differences of opinion on several important issues with the executive management of Cyberonics.  At the same time and in all fairness to the management they have always responded promptly to my calls for assistance in helping to achieve wellness for Joyce.

Joyce had a scheduled appointment to see her attending psychiatrist to interrogate her VNS prosthesis tomorrow Monday, June 29, 2015.  I sent an e-mail earlier today (Sunday) to her doctor to remind him to please have the computer equipment available to interrogate Joyce’s implant.  When we returned home later in the evening after dinner his e-mail advised me that apparently the equipment had been stolen and could I assist in obtaining a replacement.

“Sun 6/28/2015 9:38 PM” I sent an e-mail to several executives at Cyberonics enlisting their help.

“Sun 6/28/2015 10:40 PM” I received the following reply from one of Cyberonics executives:

Dear Herb,
I will work with our team in the South Florida area and the doctor to see what we can do. I don’t know if we can get something by the appointment tomorrow, but we’ll do our best.

While I may tend to be assertive in my advocacy/activism toward achieving my goals for both Joyce and her fellow patients I also try my best to be reasonably fair and balanced in my blog reporting.

Cyberonics thank you for your attention and speedy response to my request.  More specifically, thank you Bryan.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

 

—————————————————————

NOTICE OF CONFIDENTIALITY / Disclaimer

—————————————————————

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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Hacking the nervous system

© Job Boot

Hacking the nervous system

One nerve connects your vital organs, sensing and shaping your health. If we learn to control it, the future of medicine will be electric. By Gaia Vince.

26 May 2015

When Maria Vrind, a former gymnast from Volendam in the Netherlands, found that the only way she could put her socks on in the morning was to lie on her back with her feet in the air, she had to accept that things had reached a crisis point. “I had become so stiff I couldn’t stand up,” she says. “It was a great shock because I’m such an active person.”

It was 1993. Vrind was in her late 40s and working two jobs, athletics coach and a carer for disabled people, but her condition now began taking over her life. “I had to stop my jobs and look for another one as I became increasingly disabled myself.” By the time she was diagnosed, seven years later, she was in severe pain and couldn’t walk any more. Her knees, ankles, wrists, elbows and shoulder joints were hot and inflamed. It was rheumatoid arthritis, a common but incurable autoimmune disorder in which the body attacks its own cells, in this case the lining of the joints, producing chronic inflammation and bone deformity.

Waiting rooms outside rheumatoid arthritis clinics used to be full of people in wheelchairs. That doesn’t happen as much now because of a new wave of drugs called biopharmaceuticals – such as highly targeted, genetically engineered proteins – which can really help. Not everyone feels better, however: even in countries with the best healthcare, at least 50 per cent of patients continue to suffer symptoms.

Like many patients, Vrind was given several different medications, including painkillers, a cancer drug called methotrexate to dampen her entire immune system, and biopharmaceuticals to block the production of specific inflammatory proteins. The drugs did their job well enough – at least, they did until one day in 2011, when they stopped working.

“I was on holiday with my family and my arthritis suddenly became terrible and I couldn’t walk – my daughter-in-law had to wash me.” Vrind was rushed to hospital, where she was hooked up to an intravenous drip and given another cancer drug, one that targeted her white blood cells. “It helped,” she admits, but she was nervous about relying on such a drug long-term.

Luckily, she would not have to. As she was resigning herself to a life of disability and monthly chemotherapy, a new treatment was being developed that would profoundly challenge our understanding of how the brain and body interact to control the immune system. It would open up a whole new approach to treating rheumatoid arthritis and other autoimmune diseases, using the nervous system to modify inflammation. It would even lead to research into how we might use our minds to stave off disease.

And, like many good ideas, it came from an unexpected source.

 

© Job Boot

The nerve hunter

Kevin Tracey, a neurosurgeon based in New York, is a man haunted by personal events – a man with a mission. “My mother died from a brain tumour when I was five years old. It was very sudden and unexpected,” he says. “And I learned from that experience that the brain – nerves – are responsible for health.” This drove his decision to become a brain surgeon. Then, during his hospital training, he was looking after a patient with serious burns who suddenly suffered severe inflammation. “She was an 11-month-old baby girl called Janice who died in my arms.” 

These traumatic moments made him a neurosurgeon who thinks a lot about inflammation. He believes it was this perspective that enabled him to interpret the results of an accidental experiment in a new way.

In the late 1990s, Tracey was experimenting with a rat’s brain. “We’d injected an anti-inflammatory drug into the brain because we were studying the beneficial effect of blocking inflammation during a stroke,” he recalls. “We were surprised to find that when the drug was present in the brain, it also blocked inflammation in the spleen and in other organs in the rest of the body. Yet the amount of drug we’d injected was far too small to have got into the bloodstream and travelled to the rest of the body.” 

After months puzzling over this, he finally hit upon the idea that the brain might be using the nervous system – specifically the vagus nerve – to tell the spleen to switch off inflammation everywhere.

It was an extraordinary idea – if Tracey was right, inflammation in body tissues was being directly regulated by the brain. Communication between the immune system’s specialist cells in our organs and bloodstream and the electrical connections of the nervous system had been considered impossible. Now Tracey was apparently discovering that the two systems were intricately linked.

The first critical test of this exciting hypothesis was to cut the vagus nerve. When Tracey and his team did, injecting the anti-inflammatory drug into the brain no longer had an effect on the rest of the body. The second test was to stimulate the nerve without any drug in the system. “Because the vagus nerve, like all nerves, communicates information through electrical signals, it meant that we should be able to replicate the experiment by putting a nerve stimulator on the vagus nerve in the brainstem to block inflammation in the spleen,” he explains. “That’s what we did and that was the breakthrough experiment.”

 

© Job Boot

The wandering nerve

Ups and downs in the nervous systemThe vagus nerve starts in the brainstem, just behind the ears. It travels down each side of the neck, across the chest and down through the abdomen. ‘Vagus’ is Latin for ‘wandering’ and indeed this bundle of nerve fibres roves through the body, networking the brain with the stomach and digestive tract, the lungs, heart, spleen, intestines, liver and kidneys, not to mention a range of other nerves that are involved in speech, eye contact, facial expressions and even your ability to tune in to other people’s voices. It is made of thousands and thousands of fibres and 80 per cent of them are sensory, meaning that the vagus nerve reports back to your brain what is going on in your organs.

Operating far below the level of our conscious minds, the vagus nerve is vital for keeping our bodies healthy. It is an essential part of the parasympathetic nervous system, which is responsible for calming organs after the stressed ‘fight-or-flight’ adrenaline response to danger. Not all vagus nerves are the same, however: some people have stronger vagus activity, which means their bodies can relax faster after a stress.

The strength of your vagus response is known as your vagal tone and it can be determined by using an electrocardiogram to measure heart rate. Every time you breathe in, your heart beats faster in order to speed the flow of oxygenated blood around your body. Breathe out and your heart rate slows. This variability is one of many things regulated by the vagus nerve, which is active when you breathe out but suppressed when you breathe in, so the bigger your difference in heart rate when breathing in and out, the higher your vagal tone.

Research shows that a high vagal tone makes your body better at regulating blood glucose levels, reducing the likelihood of diabetes, stroke and cardiovascular disease. Low vagal tone, however, has been associated with chronic inflammation. As part of the immune system, inflammation has a useful role helping the body to heal after an injury, for example, but it can damage organs and blood vessels if it persists when it is not needed. One of the vagus nerve’s jobs is to reset the immune system and switch off production of proteins that fuel inflammation. Low vagal tone means this regulation is less effective and inflammation can become excessive, such as in Maria Vrind’s rheumatoid arthritis or in toxic shock syndrome, which Kevin Tracey believes killed little Janice.

Having found evidence of a role for the vagus in a range of chronic inflammatory diseases, including rheumatoid arthritis, Tracey and his colleagues wanted to see if it could become a possible route for treatment. The vagus nerve works as a two-way messenger, passing electrochemical signals between the organs and the brain. In chronic inflammatory disease, Tracey figured, messages from the brain telling the spleen to switch off production of a particular inflammatory protein, tumour necrosis factor (TNF), weren’t being sent. Perhaps the signals could be boosted?

He spent the next decade meticulously mapping all the neural pathways involved in regulating TNF, from the brainstem to the mitochondria inside all our cells. Eventually, with a robust understanding of how the vagus nerve controlled inflammation, Tracey was ready to test whether it was possible to intervene in human disease.

 

© Job Boot

Stimulating trial

In the summer of 2011, Maria Vrind saw a newspaper advertisement calling for people with severe rheumatoid arthritis to volunteer for a clinical trial. Taking part would involve being fitted with an electrical implant directly connected to the vagus nerve. “I called them immediately,” she says. “I didn’t want to be on anticancer drugs my whole life; it’s bad for your organs and not good long-term.”

Tracey had designed the trial with his collaborator, Paul-Peter Tak, professor of rheumatology at the University of Amsterdam. Tak had long been searching for an alternative to strong drugs that suppress the immune system to treat rheumatoid arthritis. “The body’s immune response only becomes a problem when it attacks your own body rather than alien cells, or when it is chronic,” he reasoned. “So the question becomes: how can we enhance the body’s switch-off mechanism? How can we drive resolution?”

When Tracey called him to suggest stimulating the vagus nerve might be the answer by switching off production of TNF, Tak quickly saw the potential and was enthusiastic to see if it would work. Vagal nerve stimulation had already been approved in humans for epilepsy, so getting approval for an arthritis trial would be relatively straightforward. A more serious potential hurdle was whether people used to taking drugs for their condition would be willing to undergo an operation to implant a device inside their body: “There was a big question mark about whether patients would accept a neuroelectric device like a pacemaker,” Tak says.

He needn’t have worried. More than a thousand people expressed interest in the procedure, far more than were needed for the trial. In November 2011, Vrind was the first of 20 Dutch patients to be operated on.

“They put the pacemaker on the left-hand side of my chest, with wires that go up and attach to the vagus nerve in my throat,” she says. “I waited two weeks while the area healed, and then the doctors switched it on and adjusted the settings for me.”

She was given a magnet to swipe across her throat six times a day, activating the implant and stimulating her vagus nerve for 30 seconds at a time. The hope was that this would reduce the inflammatory response in her spleen. As Vrind and the other trial participants were sent home, it became a waiting game for Tracey, Tak and the team to see if the theory, lab studies and animal trials would bear fruit in real patients. “We hoped that for some, there would be an easing of their symptoms – perhaps their joints would become a little less painful,” Tak says.

At first, Vrind was a bit too eager for a miracle cure. She immediately stopped taking her pills, but her symptoms came back so badly that she was bedridden and in terrible pain. She went back on the drugs and they were gradually reduced over a week instead.

And then the extraordinary happened: Vrind experienced a recovery more remarkable than she or the scientists had dared hope for.

“Within a few weeks, I was in a great condition,” she says. “I could walk again and cycle, I started ice-skating again and got back to my gymnastics. I feel so much better.” She is still taking methotrexate, which she will need at a low dose for the rest of her life, but at 68, semi-retired Vrind now plays and teaches seniors’ volleyball a couple of hours a week, cycles for at least an hour every day, does gymnastics, and plays with her eight grandchildren.

Other patients on the trial had similar transformative experiences. The results are still being prepared for publication but Tak says more than half of the patients showed significant improvement and around one-third are in remission – in effect cured of their rheumatoid arthritis. Sixteen of the 20 patients on the trial not only felt better, but measures of inflammation in their blood also went down. Some are now entirely drug-free. Even those who have not experienced clinically significant improvements with the implant insist it helps them; nobody wants it removed.

“We have shown very clear trends with stimulation of three minutes a day,” Tak says. “When we discontinued stimulation, you could see disease came back again and levels of TNF in the blood went up. We restarted stimulation, and it normalised again.”

Tak suspects that patients will continue to need vagal nerve stimulation for life. But unlike the drugs, which work by preventing production of immune cells and proteins such as TNF, vagal nerve stimulation seems to restore the body’s natural balance. It reduces the over-production of TNF that causes chronic inflammation but does not affect healthy immune function, so the body can respond normally to infection.

“I’m really glad I got into the trial,” says Vrind. “It’s been more than three years now since the implant and my symptoms haven’t returned. At first I felt a pain in my head and throat when I used it, but within a couple of days, it stopped. Now I don’t feel anything except a tightness in my throat and my voice trembles while it’s working.

“I have occasional stiffness or a little pain in my knee sometimes but it’s gone in a couple of hours. I don’t have any side-effects from the implant, like I had with the drugs, and the effect is not wearing off, like it did with the drugs.”

 

© Job Boot

Raising the tone

A nervy way to lose weightHaving an electrical device surgically implanted into your neck for the rest of your life is a serious procedure. But the technique has proved so successful – and so appealing to patients – that other researchers are now looking into using vagal nerve stimulation for a range of other chronic debilitating conditions, including inflammatory bowel disease, asthma, diabetes, chronic fatigue syndrome and obesity.

Gaia Vince describes a device that deals directly with the nervous system to help control obesity.

But what about people who just have low vagal tone, whose physical and mental health could benefit from giving it a boost? Low vagal tone is associated with a range of health risks, whereas people with high vagal tone are not just healthier, they’re also socially and psychologically stronger – better able to concentrate and remember things, happier and less likely to be depressed, more empathetic and more likely to have close friendships.

Twin studies show that to a certain extent, vagal tone is genetically predetermined – some people are born luckier than others. But low vagal tone is more prevalent in those with certain lifestyles – people who do little exercise, for example. This led psychologists at the University of North Carolina at Chapel Hill to wonder if the relationship between vagal tone and wellbeing could be harnessed without the need for implants.

In 2010, Barbara Fredrickson and Bethany Kok recruited around 70 university staff members for an experiment. Each volunteer was asked to record the strength of emotions they felt every day. Vagal tone was measured at the beginning of the experiment and at the end, nine weeks later. As part of the experiment, half of the participants were taught a meditation technique to promote feelings of goodwill towards themselves and others. 

Those who meditated showed a significant rise in vagal tone, which was associated with reported increases in positive emotions. “That was the first experimental evidence that if you increased positive emotions and that led to increased social closeness, then vagal tone changed,” Kok says.

Now at the Max Planck Institute in Germany, Kok is conducting a much larger trial to see if the results they found can be replicated. If so, vagal tone could one day be used as a diagnostic tool. In a way, it already is. “Hospitals already track heart-rate variability – vagal tone – in patients that have had a heart attack,” she says, “because it is known that having low variability is a risk factor.”

The implications of being able to simply and cheaply improve vagal tone, and so relieve major public health burdens such as cardiovascular conditions and diabetes, are enormous. It has the potential to completely change how we view disease. If visiting your GP involved a check on your vagal tone as easily as we test blood pressure, for example, you could be prescribed therapies to improve it. But this is still a long way off: “We don’t even know yet what a healthy vagal tone looks like,” cautions Kok. “We’re just looking at ranges, we don’t have precise measurements like we do for blood pressure.” 

Bioelectric dreamsWhat seems more likely in the shorter term is that devices will be implanted for many diseases that today are treated by drugs: “As the technology improves and these devices get smaller and more precise,” says Kevin Tracey, “I envisage a time where devices to control neural circuits for bioelectronic medicine will be injected – they will be placed either under local anaesthesia or under mild sedation.”

Treating disease could become far more precise by using bioelectronics rather than drugs.

However the technology develops, our understanding of how the body manages disease has changed for ever. “It’s become increasingly clear that we can’t see organ systems in isolation, like we did in the past,” says Paul-Peter Tak. “We just looked at the immune system and therefore we have medicines that target the immune system.

“But it’s very clear that the human is one entity: mind and body are one. It sounds logical but it’s not how we looked at it before. We didn’t have the science to agree with what may seem intuitive. Now we have new data and new insights.”

And Maria Vrind, who despite severe rheumatoid arthritis can now cycle pain-free around Volendam, has a new lease of life: “It’s not a miracle – they told me how it works through electrical impulses – but it feels magical. I don’t want them to remove it ever. I have my life back!”

http://mosaicscience.com/story/hacking-nervous-system

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"I don’t understand…please explain it to me?" VNS Therapy for depression.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, May 20, 2015 5:01 AM
Subject: “I don’t understand…please explain it to me?” VNS Therapy for depression.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, May 20, 2015 4:53 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director; Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer
Subject: “I don’t understand…please explain it to me?” VNS Therapy for depression.

Dear Madam Secretary Burwell,

Obama Admin Makes Insurance Companies Obey HHS Mandate, Offer Abortion Drugs for Free

“I don’t understand…please explain it to me?”  Why is it that the President and Federal Government can mandate and tell the health insurers they “must” follow suit and offer abortion drugs for free and yet you and your CMS agency, for the two (2) years I’ve been writing to your predecessor and you advocating for the VNS Therapy depression patients, can’t tell all your Medicare contractors in writing to rightfully cover the care once and for all for these study subjects and patients?

While we’re on the subject of “must” how is it that the Government can tell the private health insurers what they must do when CMS tells me they have no control over private health insurers when it comes to the care of these very same VNS Therapy patients?

I constantly stand in wonderment how anything in our convoluted and bloated government bureaucracy ever gets accomplished.

Once again, please read the slogans listed below taken from your own home pages.  Is there not anyone with authority and common sense within your agencies to notify all CMS contractors and private health insurance carriers of the doctrine of “Continuity of care” and the fact this doctrine was reaffirmed for these patients in your agency’s December 30, 2014 decision?

Just what does it take to get through to you people to take effective action?

clip_image001

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

—————————————————————

NOTICE OF CONFIDENTIALITY / Disclaimer

—————————————————————

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, May 11, 2015 2:14 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director; Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer; Courtney Turner; Nancy Conn – DMOA Acting Deputy Director
Subject: Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007.

Dear Madam Secretary Burwell,

clip_image001

http://www.hhs.gov/about/

So exactly when does your agency/bureaucracy actually do something helpful and effective “for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves”?

It has been two (2) years now that I’ve been on this project advocating and writing to former Secretary Kathleen Sebelius and you.  My original pleas were for “Compassionate Use” only to learn all along your CMS agency incorporates the doctrine of “Continuity of care” which rightfully should have insured medical coverage for this unique population of patients implanted with a medical device being denied care and/or replacement by your various contractors. 

The decision of December 30, 2014 reiterates this fact of “Continuity of care”.

What does it take to get any of you people to understand that it is rightfully your responsibility to care for these patients (read you’re agencies statement at the beginning of this communication) and you folks are failing?  Why can’t you add an addendum to the NCD of May 4, 2007 noting the fact that all VNS Therapy depression patients implanted prior to that date are rightfully to be covered?  Why can’t any formal message, document or piece of paper be sent to all your Medicare/Medicaid contractors to inform them what should have properly been included in the original decision but was egregiously or negligently and/or intentionally overlooked and/or omitted?

Why can’t anyone in the multitude of your agencies personnel get the message out to all your contractors?  Why must the patient, “least able to help themselves” be forced to appeal? 

“Please note, that if a particular Medicare claim is not paid, the Medicare beneficiary has the right to appeal.” — Dr. Patrick Conway, CMS Chief Medical Officer.

Why it is your own people don’t understand the true realities of life/procedures from the patient viewpoint?  The hospitals will not proceed unless they get the okay from MAC.  The hospitals will not perform surgery for replacement of the prosthesis for a depression patient although they will perform the exact same surgery for an epilepsy patient.  Obviously your own people don’t know it is not a question of appealing non-payment but first obtaining approval for the surgery and/or care in the first place.

It is truly, truly sad and maddening situation as I sit here writing to you for the umpteenth time to tell you, in my opinion, of the ineptness and what I consider the incredible incompetence within your agency based upon some of the answers and/or communications that I receive based upon patient pleas asking for my assistance to overcome your contractor’s denials.

Why can’t you in writing or one of your subordinates inform all your Medicare/Medicaid contractors in one document submission that these VNS Therapy depression patients are to be covered and treated exactly the same as the VNS Therapy epilepsy patient?  Is that too difficult for anyone to comprehend?

I no longer have to beg for “Compassionate use”.  I now ask that you only do what are rightfully your job and that of all your subordinates and that which has been adjudicated within your own agency. 

Medicare/Medicaid coverage is rightfully to be covered for all VNS Therapy depression patients implanted prior to May 4, 2007.

The next letter I would truly hope to receive from either you or any of your subordinates is one informing me that all the Medicare/Medicaid contractors have rightfully been informed and acknowledge that all VNS Therapy depression patients implanted prior to May 4, 2007 are to be covered for both care and replacement of their medical devices without any further need or discussion for any appeals.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

—————————————————————

NOTICE OF CONFIDENTIALITY / Disclaimer

—————————————————————

Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke

UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke

Published on May 8, 2015

ut

A recent university news release from UT Southwestern Medical Center reports that the center will be one of three national sites to pioneer US testing for an implant device designed to stimulate the vagus nerve in stroke patients; the aim is to determine whether the technology can help restore lost arm function.

The release states that the device, known as the Vivistim System, was developed by Dallas-based company MicroTransponder Inc with a license from UT Dallas. The technology is engineered to stimulate the neck’s vagus nerve. It is implanted under the collarbone and is about the size of a pacemaker. According to the release, it sends painless, half-second electrical pulses up the vagus nerve, causing neruomodulators to be released in various parts of the brain. There are also alternate forms of vagus nerve stimulation therapy already approved for use by the FDA for treating other illnesses, such as depression and epilepsy, the release adds.

The neuromodulators “appear to facilitate the creation of new neuron pathways in the brain, which play a key role in restoring muscle movement,” says Ty Shang, MD, PhD, in the release.

Shang is an assistant professor of Neurology and Neurotherapeutics, UT Southwestern, and is heading the UT Southwestern arm of the trial.

A stroke deprives brain cells of oxygen, and without oxygen, brain cells die and can no longer perform the function for which they were intended, Shang points out.

“There has been no known way to regenerate new brain cells to replace them, but in early tests with this device, the brain appears to ‘rewire’ other cells to perform the function,” he adds.

The Vivistim System is built to improve motor function in the more involved arm of a patient post-stroke. The technology was studied beginning in 2013 for efficacy and safety in a small study in Glasgow, Scotland, the release says. Individuals in the Glasgow study reportedly experienced meaningful, functional improvements in their more involved arm.

Shang theorizes that VNS therapy may serve as the stimulus for motor relearning with the more involved arm for individuals post-stroke. While gaining functional improvement in the impaired arm can be a challenge, Shang says, “VNS therapy might make achieving functional gains easier.”

The release notes that currently, UT Southwestern researchers are seeking individuals in the Dallas-Fort Worth metroplex who sustained a stroke 4 months to 5 years ago to participate in the trial.

Once participants have undergone outpatient surgery to implant the device, the release says they will be scheduled for 18, 90-minute sessions of intensive, task-specific therapy during a 6-week period, with quarterly follow-up evaluations for the next year.

Interested participants can visit www.vnsstroketrial.com or contact the Department of Physical Therapy at (214) 648-1533.

[Photo Credit: UT Southwestern Medical Center]

[Source(s): Newswise, UT Southwestern Medical Center]

http://www.ptproductsonline.com/2015/05/ut-southwestern-one-sites-test-implant-device-designed-restore-arm-function-post-stroke/#sthash.flR5WI14.dpuf

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VNS Therapy for Depression – "to hang on their individual desks and walls so that they finally get the message"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, April 24, 2015 2:56 AM
To: Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer
Cc: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director
Subject: VNS Therapy for Depression – “to hang on their individual desks and walls so that they finally get the message”

Dear Dr. Conway,

On the Internet about page of HHS.gov you’ll find the following quotations:

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First, thank you for taking your valuable time to respond to my recent email to Madam Secretary Sylvia Burwell.  For purposes of this response I shall not at the moment address “Medicare has no jurisdiction over coverage decisions of a private insurance company.”  What I would like to address is that I have been cited and admonished in my two (2) years of advocacy and correspondence for this unique VNS Therapy depression patient population for my sometime harsh rhetoric in addressing/responding to those who work for the bureaucracy of HHS/CMS.  I therefore wish to point out that which follows may be harsh and is not a personal indictment of you.

I have spent two (2) years advocating and battling with HHS/CMS only to find out that your own agency acknowledges the doctrine of “Continuity of care” and these patients should have rightfully been attended to and cared for from the onset.  And yet, there are still obstacles being thrown in our way as evidenced by your letter whether through lack of knowledge, incompetence or bureaucratic sludge.

Please read those quotations listed above real carefully once again and then tell me the contents of your letter to me adhere to those principles.  My father-in-law, may he rest in peace, used to use spoonerisms at times to raise attention and/or get his point across.  One such spoonerism is the fact that you’ve got this matter “backasswards”.  I’m well aware of NCD of May 4, 2007, which incidentally only applies to depression patients, but you totally omit addressing your own agencies recent decision of December 30, 2014 and the doctrine of “Continuity of case as I quote:

VII. The AGGRIEVED PARTIES’ CONTENTIONS REGARDING MEDICARE BENEFITS WHO WERE IMPLANTED WITH THE VNS DEVICE PRIOR TO MAY 4, 2007 PROVIDE NO BASIS FOR INVALIDATING NCD 160.18(C).

The Aggrieved Parties suggest that NCD 160.18(C) is invalid because it does not address the needs of Medicare beneficiaries with TRD who were implanted with the VNS device and received Medicare coverage for VNS prior to the issuance of NCD 160.18(C) on May 4, 2007. Statement ¶¶ 38-43; Complaint ¶¶ 90-95. With respect to those beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for: (1) “the interrogation and calibration of a VNS therapy device implanted and deemed to be reasonable and medically necessary when implanted for TRD”; or (2) “for the replacement of the implanted pulse generator device upon battery expiration, when required[.]” AP Statement ¶ 43. According to the Aggrieved Parties, those omissions conflict with: (1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).

Why any of these seriously ill depression patients must be challenged by your bureaucracy to have to file an appeal is anything but effective management in my opinion or in line with “Continuity of care” as cited in the above quotation from the December 30, 2014 decision.  Is there no one in all of your agencies with the authority or capability to issue a formal document of notification to any and all of your “local Medicare Administrative Contractors” to hang on their individual desks and walls so that they finally get the message?  These patients are to be covered by Medicare/Medicaid period.

With all due respect to you and the fact I’ve been a mental health advocate/activist and support person over a half century, your letter to me is one which I refer to as “bureaucratic speak”.  It sounds good but effectively accomplishes nothing.  How’s about also getting the message out to MAC (Medicare Appeals Council)?  So when the hospital applies for patient coverage for replacement surgery MAC can expeditiously approve the request because they would already have the “Continuity of care” decision of December 30, 2014 to guide them thereby significantly lessening the stress and anxiety on an already ill patient in line with the precepts noted early on in this message?  How’s about finally producing some effective and productive document to put these issues to bed?

The former Deputy Administrator Director, Jonathan Blum, put in place a contact individual within your organization to expedite and lessen the stress on the patient in order to obtain their replacement prosthesis.  In view of the fact that CMS acknowledges the doctrine of “Continuity of care” and the rightful medical coverage for these patients why is it seemingly so difficult to get the damn message out to your bureaucracy and get them all on the same page at the same time?  Send me a new letter telling me these issues have been resolved and then I can feel you and your agency have finally accomplished something and become effective.  Until that time I’ll consider these various replies as the normal “bureaucratic speak” that comes from DC.

Once again, thank you for taking the time to respond to my advocacy for the VNS Depression patients.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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