Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Wednesday, February 26, 2014

The view from the skyboxes can be awfully deceiving...

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, February 27, 2014 12:23 AM
To: Stephen J. Hemsley - CEO, United Healthcare
Subject: The view from the skyboxes can be awfully deceiving...

Dear Mr. Hemsley,

Please pardon my brief absence.  An abdominal surgery kind of slowed me down but as I heal my energy and thought processes increase and bring me back to what could be a simple act on your part and considerable savings to your company as well as a life changing circumstance for your subscriber the VNS Therapy patient.

As you sit way up there in the skyboxes the view can truly be deceiving as to the nuisances that really take place on the playing field.  You receive a message from me and kindly and promptly hand down a message to some subordinate department head and he/she then hands off to another subordinate who hires some doctor for your company as a so called independent opinion when in fact none of these players had shared the sweat of the playing field and realities at game level. 

Would you like some understanding of what you and your company and that of others spend unfathomable sums of money on ineffective therapies for these depression patients?  I know you don’t have the time to read what is truly happening on the field of play but I’d like to give you some feel of the realities of these other conventional ineffective treatments when compared to the reality and experiences of a patient, your subscriber, and the knowledge shared with your company by her attending physician telling you that the VNS Therapy has benefited your subscriber in the past and will in all likelihood continue to do so for years to come.

Here’s a piece written by a retired psychiatrist, Dr. John M. Nardo, whom I follow from time to time that I feel you and others might find of interest.  I’d also suggest reading the comment from Dr. Sandra Steingard at the very end in which she stated, “…why don’t we try to understand and listen to what they are saying?”

The fact is conventional therapies have not worked for my spouse or your subscriber or the other VNS Therapy patients.  What is being told to you by your subscriber (the patient), her attending physician, me and if you choose other attending physicians that despite your skybox view and that of those your hire(s), VNS Therapy has worked and continues to work efficaciously for those patients who seek replacement surgery down on the playing field and in real-life, day-in and day-out.

The answer and understanding Mr. Hemsley is for you to rightfully exercise your executive authority to stop the B.S. and shit-from-shinola opinion(s) from those who are not in this ball game and to immediately direct which ever subordinate you choose to execute the approval for this replacement surgery and put your subscriber (the patient) back on the road to good health to play another ball game.

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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Saturday, February 22, 2014

Depression Likely The Biggest Incremental Driver For Cyberonics

Stephen Simpson, CFA, Kratisto Investing (253 clicks)

Long only, growth at reasonable price, value, research analyst

Send Message| Follow (2,249)

Depression Likely The Biggest Incremental Driver For Cyberonics

Feb. 5, 2014 1:49 PM ET  |  About: CYBX, Includes: BSX, MDT, STJ by: Stephen Simpson, CFA

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. (More...)

This article was first released only to PRO subscribers. Learn More

Watching Cyberonics (CYBX) evolve over the years has been pretty compelling. I was part of a sell-side research team that covered the stock in the late 90s and early 00s and followed the company as it struggled to gain the acceptance of the FDA, physicians, and patients, not to mention overcome a particularly aggressive CEO. In more recent years, the company has settled into a solid growth trajectory driven by incremental market penetration and a very strong replacement cycle, while delivering impressive margins.

The question is what comes next. While I do believe the company's core addressable market in developed countries (epilepsy) remains significantly under-penetrated, I don't see that changing rapidly or dramatically. That puts even more significance on the under-developed opportunity in depression, where the company has only a limited opportunity to drive real change. Although these shares aren't all that expensive relative to other growth med-techs on the basis of multiples, it's going to take either accelerated penetration in epilepsy or upside in depression to drive a higher intrinsic fair value.

A Device-Based Approach To An Undertreated Disease

Cyberonics pioneered the use of vagus nerve stimulation (VNS therapy) to treat drug refractory epilepsy and it remains a market that the company essentially has all to itself in the U.S. Although epilepsy has been a recognized medical condition for quite some time, pharmaceutical companies have struggled to develop effective medications that don't also carry significant side effects or an impaired quality of life. With that, there are over 1.2 million people with epilepsy in developed markets (the U.S., EU, Japan and so on) that could benefit from the therapy offered by Cyberonics.

Cyberonics has developed a series of devices to deliver vagus nerve stimulation. In all cases the therapy involves a pulse generator (similar to a pacemaker/ICD) and a lead that connects the pulse generator to the left vagus nerve in the neck. The device can be implanted in an outpatient procedure (the generator is implanted in a subcutaneous pocket in the upper left chest) and it works by sending intermittent pulses of electricity to the left vagus nerve that reduce the frequency and severity of seizures. Physicians can adjust the therapy non-invasively, and patients can use a small magnet to manually adjust therapy if they sense an impending seizure.

How well vagus nerve stimulation works is a more subjective question than you might think. Clinical studies have shown that roughly one-quarter of patients see a 50% or greater reduction in seizure frequency after just one month, and more than one-third of patients achieve that level at one year. Side effects from the device are mild (hoarseness being the most common, and it usually improves with time) and the device can be removed when/if necessary.

Even so, the device does not often lead to a total cessation of seizures (about 10% to 15% of patients) and this is one of the more frequent complaints of doctors. While about 25% of patients drop out after the first implant expires (the devices last about five years on average), more than 90% of those who get a second implant stick with it thereafter.

Innovation And Replacements Drive Epilepsy

Acceptance of vagus nerve stimulation has never reached the levels that were hoped for in the 1990s, and this has historically been one of the bigger sources of volatility and complaint with the company/stock. Overall, Cyberonics has only penetrated about 5% to 6% of its theoretically addressable market, with double-digit penetration in the U.S. and some select European markets.

To its credit, the current management team of Cyberonics has guided the company in line with these market realities and has built a model focused around a strong replacement cycle (approximately 40% of revenue) and incremental value-added product development. On the replacement side, implants last around five years on average, with 3-4% annual price increases (and sometimes higher when there are meaningful advances).

In terms of new products, Aspire SR could be a very significant new product. It's going to be a couple of years before this product makes it to market in the U.S., but the device was designed with a "seizure response" feature that monitors the patient's heart rate and provides increased stimulation when it appears that a seizure is coming. The E-36 study has produced some encouraging data and good results in the E-37 U.S. study could not only drive FDA approval, but perhaps increased commercial/market acceptance as well.

New Markets Have Long Been Promising… And Difficult

For over 15 years now, Cyberonics has tried to develop additional market opportunities for VNS therapy. Drug-resistant depression was one of the earliest targets and although initial studies were not positive for the device, subsequent studies have shown a meaningful benefit for many patients who have not responded to drugs.

While the FDA has approved VNS therapy for depression patients who have not responded to at least four drugs, the company has been stymied thus far in securing adequate reimbursement. Cyberonics continues to work on this, and is trying to get the CMS to reconsider its coverage for a subset of seriously ill patients. This subset includes about 70,000 patients in the U.S. alone and could represent $1.5 billion in potential revenue but getting payers to go along has been an uphill battle for some time.

Among other potential indications, Cyberonics is also pursuing the possibility of VNS therapy as a treatment for congestive heart failure. Pilot study data are due later this year, but it's hard not to be skeptical. Device-based interventions for CHF have a pretty poor history, as only a limited subset of patients have responded well to the cardiac resynchronization therapy approach pushed by Medtronic (MDT), St. Jude Medical (STJ), and Boston Scientific (BSX).

This pilot study is targeting patients with Class II/III heart failure, which overlaps with the CRT market addressed by Medtronic, St. Jude Medical, and Boston Scientific. These companies have all been working on getting more usage in Class II patients (the higher the class, the worse the condition), as only about 20% to 30% of Class III patients are good candidates (and about 30% of patients don't respond to CRT therapy).

BioControl Medical has already shown that vagus nerve stimulation may be a productive approach - a small two-stage study saw patients getting VNS migrate from a distribution of 47% Class II, 47% Class III and 6% Class IV to 34% Class I / 48% Class II / 17% Class III and 43%/43%/13% at 6-month and 12-month follow up, respectively. There were also significant improvements in exercise tolerance and quality of life.

Unlike CRT from Medtronic/Boston Scientific/St. Jude, the approach being explored by Cyberonics and BioControl involves restoring or augmenting parasympathetic function and works on the autonomic nervous system instead of stimulating/shocking an already damaged heart. This opportunity could address over 1 million patients (and perhaps 2 million or more) and at an ASP of $15,000 or so, the numbers get very large very quickly ($15 billion-plus at 100% penetration). Were this approach to show solid clinical efficacy, I would not be surprised to see Cyberonics partner with Medtronic, St. Jude, or Boston Scientific or receive a buyout offer.

A Little Competition May Not Be A Bad Thing

Although many key patents on VNS therapy expired in 2011, Cyberonics has seen little direct competition. Neurotech and Cerebral Rx have CE-marked VNS approaches, while Medtronic and St. Jude have been more interested in pursuing deep brain stimulation for epilepsy and depression. NeuroPace has advanced its RNS System (Responsive Neurostimulator System) and it has shown better seizure reduction at one-month and one-year periods, but it requires a cranial implant (brain surgery) and more complicated programming.

Odd as it may sound, getting a major player in neuromodulation like Medtronic, St. Jude, or Boston Scientific to get involved in vagus nerve stimulation wouldn't necessarily be the worst thing for Cyberonics. Market/doctor acceptance is still a major issue and the marketing muscle of one of those companies could bring some much-needed attention to the therapy. Given that these companies have all pushed other therapies (in different therapeutic areas) in the past with even weaker efficacy profiles, I do find the lack of interest in vagus nerve stimulation to be interesting.

The Bottom Line

I am not modeling significant uptake in depression at this time, leading me to project roughly 9% long-term annual revenue growth on the strength of additional market penetration in epilepsy and ongoing replacement sales. That supports an intrinsic fair value in the $50s today, with an EV/revenue approach (using a 6x multiple that is consistent with growth med-tech) suggesting a mid-$60s target price. Were Cyberonics to achieve 5% share in depression in the U.S. (of that 70K patient subset), the DCF-based fair value would move into the $60s, but it would take more than 10% share to get to the current average sell-side target price of almost $76.

I realize that growth med-tech stocks trade on revenue growth and revenue multiples and rarely on margins or FCF. With that, an unexpected improvement in market penetration or positive news on reimbursement in depression would certainly be good for the stock. I'm not fond of owning stocks trading above what I believe to be intrinsic fair value, though, so I don't anticipate adding these shares to my own portfolio in  the near term.

http://seekingalpha.com/article/1996061-depression-likely-the-biggest-incremental-driver-for-cyberonics.

Cyberonics (CYBX) AspireSR Generator Receives CE Mark

 

Cyberonics (CYBX) AspireSR Generator Receives CE Mark

February 20, 2014 7:16 AM EST

Cyberonics (Nasdaq: CYBX) announced the CE Mark (Conformité Européenne) approval in Europe for the AspireSR generator, the novel sixth-generation VNS Therapy generator.

The AspireSR generator provides the well-established benefits of VNS Therapy, coupled with a new feature – Automatic Stimulation in response to detection of a seizure.

Proprietary technology enables the AspireSR generator to analyze relative heart rate changes to detect and respond to seizures. This technology is based on a growing body of evidence that seizures are often accompanied by an increase in heart rate (ictal tachycardia). With the Automatic Stimulation feature, the AspireSR generator better aligns stimulation with the clinical onset of a seizure.


Currently, patients experiencing VNS Therapy can use a hand-held magnet to activate stimulation manually when they anticipate the onset of a seizure. This on-demand stimulation has been shown to stop or shorten a seizure, reduce seizure severity, and improve or shorten the postictal (post-seizure) recovery period. The Automatic Stimulation feature of the AspireSR generator may benefit patients who experience seizures accompanied by ictal tachycardia and are unable to perform on-demand stimulation with the hand-held magnet, do not have a magnet available when needed, or experience a seizure while sleeping.


Results of the E-36 clinical study, which evaluated the performance and safety of the AspireSR generator, were presented at the American Epilepsy Society meeting in December 2013. The study met its primary performance endpoint, and the safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems.
"A significant number of people living with refractory epilepsy experience heart rate changes during their seizures," stated Prof. Dr. med. Christian E. Elger, FRCP, Head of the Department of Epileptology at the University Hospital of Bonn, Germany. "AspireSR builds upon the VNS Therapy platform by providing a unique, innovative possible therapeutic option for these patients by automatically detecting and responding to seizures upon heart rate increase."


"European approval of the AspireSR generator represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced, device-based solutions for people with epilepsy," said Dan Moore, President and CEO of Cyberonics. "This new generator will be particularly helpful to VNS Therapy patients who are unable to use magnet-activated stimulation consistently. We believe the Automatic Stimulation feature will continue to advance VNS Therapy as a foundational therapy for people with refractory epilepsy."

 

http://www.streetinsider.com/Corporate+News/Cyberonics+%28CYBX%29+AspireSR+Generator+Receives+CE+Mark/9194482.html

Wednesday, February 19, 2014

Scientists unveil the mechanisms underlying the immediate effect of deep brain stimulation in depression

Scientists unveil the mechanisms underlying the immediate effect of deep brain stimulation in depression

February 18th, 2014 in Psychology & Psychiatry /

A team of UCA researchers led by Professor Esther Berrocoso and in joint collaboration with the mental health research groups of the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM) have carried out a pioneering project in Spain.

A research team at the University of Cadiz, headed by Professor Esther Berrocoso, in joint collaboration with mental health research groups of the Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM) and the Instituto de Salud Carlos III, have conducted a pioneering translational study on the immediate antidepressant effect of deep brain stimulation (DBS) which, so far, has yielded outcomes that are scientifically and clinically significant for patients who suffer from major depression and do not respond to currently available treatments.

In fact, last 28 May, the most prestigious scientific journal of mental health, with the highest impact factor, Molecular Psychiatry, published a paper on DBS by UCA's PhD student and Laura Perez-Caballero and Professor Esther Berrocoso, as main researchers. The paper was also written by Juan Antonio Micó, also from UCA, as well as scientists at Salus Infirmorum (Cádiz), Hospital de la Santa Creu i Sant Pau (Barcelona) and Universidad Complutense (Madrid): Carmen Romero-Grimaldi, Rosario Pérez-Egea, Dolors Puigdemont, Victor Pérez, Joan Molet, Javier R. Caso and Juan Carlos, all of them members of the CIBERSAM network.

In order to fully understand the finding, it is worth pointing out that, in Spain, one out of five women and one out of ten men will suffer from depression sometime in their lifetime. Nowadays, half of the patients with major depression (the most severe type of depression) do not respond to treatment: symptoms persist despite complying with treatment for enough time. In such cases, the patient often ends up with chronic functional disorder. However, resistance to treatment can have more severe consequences. It is estimated that major depression is present in 70% of completed suicides and this is why research into new therapeutic approaches is needed.

The studies, conducted at basic and clinical levels, have unveiled that the immediate or early effect of the DBS technique to treat patients with major depression is conditioned by delivery of analgesic and anti-inflammatory drugs after surgery.

That being said, it must be explained that DBS is a neurosurgical procedure that has been successfully used to treat patients with Parkinson's disease for a long time now. Since 2005, the technique has been used as a neurosurgical treatment to treat diverse psychiatric disorders and mainly treatment-resistant depression due to its special severity. The procedure is a surgical treatment in which an electrode is placed into the patient's brain in order to stimulate the subgenual cingulate, an area in the cerebral cortex which shows altered activity in patients suffering from such a disorder. Clinical trials conducted to date across different countries have shown that the response rate, one year after start of treatment, is higher than 60% (nearly two out of three patients). Notwithstanding, the studies had also unveiled that a transitory improvement, whose underlying mechanisms were unknown, took place immediately after the surgical procedure.

"It must be noted that patients with treatment-resistant depression is a difficult case since they are patients who have not responded to conventional treatment. When the technique was introduced, the first results yielded were very promising – to the extent that the initial antidepressant effect after electrode implant was attributed to the patients' own great recovery expectations. However, in our study we posit the existence of an additional neurobiological mechanism," as UCA researcher Esther Berrocoso explains.

Thus, a series of pre-clinical studies were conducted at UCA in order to research into the neurobiological mechanisms responsible for the immediate and early response caused by the technique. Unsurprisingly, as it sometimes happens in science, the data provided by our studies suggested that a clear antidepressant effect resulting from an inflammatory phenomenon taking place in the area of the injury appeared during the early stages of treatment. To put it another way, it was found out that the neurosurgical procedure involving implantation of the electrodes over the cerebral cortex caused the production of molecular mediators for a short period of time, causing a clear and immediate antidepressant effect," as the head of the study, Dr Berrocoso, explains.

The research work done in the study has unveiled some of such mechanisms. In particular, the technique's immediate or early response involves a complex local inflammatory phenomenon accompanied by protein molecule synthesis over the cerebral cortex, highly important for producing the antidepressant effect. In other words, the immediate antidepressant effect is associated with the protein expression (p11) and a local inflammatory phenomenon taking place in a very specific area of the brain which "is not precisely bad but useful in improving of depressive state."

In fact, thanks to the work done by the UCA researchers and the various CIBERSAM research teams, "we can suggest that shortly after electrode implantation a series of other beneficial molecular phenomena takes place, apart from the ones caused by brain stimulation itself," as Professor Esther Berrocoso explains.

As a result of the findings on inflammation, the team of scientists believes that "the analgesic/anti-inflammatory drugs that are delivered to control pain in patients after surgery could be, at first, counterproductive to the antidepressant effect". In fact, "we have retrospectively examined resistant-treatment depression patients that had been treated with the technique at Hospital de la Santa Creu i Sant Pau in Barcelona and taken analgesic drugs, and then compared them with those who had not needed them. The result was that the patients who had not taken anti-inflammatories recovered better from depression during the initial stage".

Therefore, to continue the investigations being carried out, "we are studying the use of analgesic drugs that have no anti-inflammatory effects. That is to say, we are working on the development of other protocols for pain control that do not interrupt the aforementioned beneficial and antidepressant effect, since this is the way patients with a severe type of depression can be treated effectively the soonest possible." Moreover, the UCA researcher also highlighted that "even though the results are promising, it is necessary to speak cautiously as our hypothesis needs to be tested in a larger sample patients."

Consequently, researchers at UCA have already decided to take a step further, and "although the outcomes relating to the technique's antidepressant effect are promising, we must not forget that we are talking about a technique that requires precise intracranial surgery. Therefore, the aim of our team is to examine what particular neurochemical changes are caused by the neurosurgical technique in detail in order to turn such changes into a possible therapeutic target by adopting a less intrusive approach," as Esther Berrocoso says.

Provided by Universidad de Cádiz

"Scientists unveil the mechanisms underlying the immediate effect of deep brain stimulation in depression." February 18th, 2014. http://medicalxpress.com/news/2014-02-scientists-unveil-mechanisms-underlying-effect.html

Friday, February 14, 2014

“There are doctors, good doctors and better doctors.”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, February 14, 2014 4:13 AM
To: Stephen J. Hemsley – CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: “There are doctors, good doctors and better doctors.”

Dear Mr. Hemsley,

Now that I’ve explained how I go “Totally Bananas” every now and then and the fact I’ve been extremely busy these past nine or so days battling Joyce’s new health insurance company as it relates to her medications (another absurd and dysfunctional bureaucracy), it’s time I get back to my advocacy and battling the bureaucracy and lunacy at United Healthcare.

Along time ago I learned that when a physician hangs out his/her shingle to practice medicine it does not state whether they graduated first or last in their class.  In addition, I also learned there are doctors, good doctors and better doctors.  Please keep these points in mind which I shall come back to address shortly,

As part of my learning process I welcome feedback and discussion from both patients and physicians.  I’ve just recently learned from a patient there is another distinguished health insurance executive who apparently gives a damn for the patient and is not blind-sided by questionable policy statements and questionable opinions from questionable physicians never having actually examined the patient. 

Kudos to you Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield and your people as I’ve learned from your private subscriber payer, formerly denied medical coverage, that your company has changed its position in respect to your subscriber.  This patient just recently received approval for VNS replacement surgery from both her employer and CareFirst.  This reasoned approach in this situation was to provide “continuity of care” while maintaining patient wellness is one of several reasoned factors and the rightful thing to do.

Bravo to you Mr. Burrell and your organization.  Not too many of these large organizations (bureaucracies) truly care and think rationally what is both good for the patient and a long-term cost savings to the corporation.

I would like to extend my sincere appreciation to you, Mr. Burrell for doing the right thing.  I’m sure the patients, physicians and government officials who receive my email distributions can also appreciate your positive and caring stance relating to these truly serious situations and ill patients.

Which now brings me back to you Mr. Hemsley and your organization at United Healthcare.

In my opinion your organization’s disingenuous and contrived response to your subscriber in denying both the patient’s initial request and first appeal as well as not comprehending the urgency letter of need as written by the patient’s highly qualified and distinguished psychiatric medical professional is truly obtuse and absurd on your company’s part.  The fact that your Maureen S., Resolving Analyst was mindful in her letter of January 16, 2014 to cite (as I’ve quoted several places below) that all the supporting documents were referred to Medical Director, Amy Schneider, M.D. is most interesting and in some ways laughable, at least to me anyway.  And which also brings me back to “doctors, good doctors and better doctors.”

“All of the supporting documentation was referred to a Medical Director, Amy Schneider, M.D.,

specializing in Neurology, not previously involved in this decision, for review.”

“We carefully reviewed the documentation submitted, our payment policies and the limitations,

exclusions and other terms of your Benefit Plan, including any applicable Riders, Amendments,

and Notices. We confirmed, however, that this service(s) is not eligible for payment as you

requested. You are responsible for all costs related to this service(s).

Amy Schneider, M.D., specializing in Neurology, reviewed your appeal. This decision was made

based on Vagus Nerve Stimulation 20J3TOI01 P. The determination is as follows:

Your doctor has requested coverage for a device known as a vagal nerve stimulator to treat clip_image001

This feeble letter and the opinions and statement contained therein reminds me of the former Senator and doctor, Dr. Bill Frist rendering his opinion in the Terri Schiavo case.  What a sad and disgraceful commentary he exhibited and offered up.

An Internet search for Amy Schneider, M.D. yields a minimum of four (4) doctors with the same name, three (3) of whom appear to practice in Arizona so I’ll presume your company’s representative is referring to Amy G. Schneider, M.D. of Scottsdale, AZ.  Please correct me should I be wrong?  Of additional note of interest to me when searching for Dr. Amy G. Schneider is the very lack of information pertaining to the physician.  Medical Director…of what?  I could find no published studies and/or papers prepared by the doctor.  So please explain to me exactly what are the outstanding qualifications of Dr. Schneider to have qualified her to review and offer up an opinion in this case?  Upon further search I came upon the doctor listed at a mail route in AZ and P.O. Box in Minneapolis, MN.  I called the doctor at the listed telephone number and I apparently caught her off-guard.  I did introduce myself and stated my full name and the fact I am Mental Health Advocate/Activist and I just wanted to learn and better understand her Curriculum Vitae and other qualifications.  Boy did she clam up ever so fast.  I’m curious Mr. Hemsley if you or your staff had ever reviewed the Curriculum Vitae and qualifications and/or considered asking Drs. Charles Conway or  Mark George or Harold Sackeim or John A. Rush or John O’Reardon or David Dunner or Scott Aaronson or Paul Goodnick but to name only a few highly qualified and noted psychiatric practitioners their thoughts and professional opinions regarding your subscriber and/or VNS Therapy for this unique patient population?

Obviously you, your company nor Dr. Schneider noted any more recent documents and articles or took any time to read a recent finding of Dr. Charles Conway and an opinion by Dr. William Bunney which differs from Dr. Schneider’s opinions.

In reviewing your subscribers appeal and that of his/her psychiatric physicians how is it that your doctor’s opinion did not take into account in her recitation about drugs the very fact that this therapy is not a drug so why in the world does she fill the document discussing drugs?  In fact it is a newer neuro-modulation therapy so your company’s lengthy diatribe about medication is simply not applicable in this situation.  You too have made the very same mistake that is part of the initial controversy relating to this treatment.  VNS Therapy is not a drug but a medical device.  In hindsight we all can agree the studies should properly have been designed to allow for a minimum of one year study.  Instead it was inappropriately based upon a protocol of a 12-week-drug-protocol.  This fiasco should be a text book case study for what not to do and I am quite sure Medtronic and St. Jude took this into consideration when designing their DBS studies.  So with that fact in mind it does not preclude that the therapy is either unsafe or ineffective as was faultily reasoned by Dr. Schneider.  The fact is those patients who wish to continue with the therapy, i.e. your patient subscriber, has responded and obtained efficacy continuously for several years contrary to the gibberish presented and the very reason CMS has finally come to understand the benefits being derived by this implanted group of patients.  The very exact same therapy you approve and pay for in epilepsy patients are also being utilized by a number depression patients and they too are benefiting.  For the epilepsy patient you illogically reason it is both safe and efficacious and not so for the depression patient?  Give me a break!  Is that not stupidity or something close to it?

I’ll also point out to you and Dr. Schneider that 100% of the VNS depression patients wanting to continue with this therapy are both responders and obtaining long-term efficacy.  Should you want to discuss statistics, this response rate and long-term efficacy is unheard of when treating this unique group of severely depressed patients.  I guess this fact may also have been overlooked by both you and Dr. Schneider. 

Your company pays for cross over medications approved for epilepsy that were never adequately double-blind studied for depression patients.  You pay for ECT and yet there has never been any large double-blinded study approved by the FDA.  Add to the fact that after many years ECT was finally acknowledged to have potential serious side-effects of cognition and memory impairment and was officially recognized in a study by Dr. Harold Sackeim.

Your recent policy decision of February 1, 2014 in my opinion is a “Swiss Cheese Policy”.  One truly full of holes contrived to fill your companies political and financial objectives.  The facts and realities are that some of the worst of the worst depression patients who have suffered in agony and anguish for decades after having tried all the available conventional therapies, like my spouse, and who have had numerous yearly hospitalizations have finally responded, benefited and have obtained long-term efficacy from VNS Therapy despite your irrational protestations.  These individuals and their more knowledgeable attending physicians know the therapy works for their implanted patients unlike your Dr. Schneider with her Dr. Bill Frist type political and medical agenda and opinions made from afar. 

I was also reminded by another of your private subscriber payers denied coverage for a VNS replacement several years ago, only at that time the opinion was written and submitted by Eugene B. Lofton M.D., Regional Medical Director.  Dr. Lofton’s specialty being Internal Medicine.  It seems you have propensity to hire physicians (sort of like ghost writers) whose opinions affecting people’s lives come with questionable expertise and/or credentials. 

I’d make a suggestion should you ever have need for brain surgery; don’t accept the writings of a hired proctologist for his/her health care opinion.

There comes a time in one’s life that one has to be guided by one’s conscience to do what is right and just.  Mr. Hemsley your time is now.  You have the power and the authority like Chet Burrell to maintain the “Continuity of care” and wellness for your subscriber.  Like your fellow CEO, Chet Burrell, you too can do what is right.  Only do it now!  There is no need for this patient to agonize, suffer and worse yet when we know there is a treatment, proven in her case history, that will alleviate her illness and set the patient on a road to recovery for you and/or your company to obstinately stand in the way of him/her achieving wellness.

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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Saturday, February 8, 2014

I go “Totally Bananas”

As you know from many of my writings pertaining to VNS Therapy it is often of a very serious nature especially when endeavoring to right serious wrongs and advocating for the wellness of others. Quite often when facing these daunting challenges and the unbelievable and illogical reasoning I encounter while challenging the bureaucracy, I go “Totally Bananas”.

With that thought in mind and my tongue-and-check sense of humor, I’d like to share something on the lighter side of things about some dear friends of ours.

Sincerely,

Herb

 

Sun Sentinel

7:17 a.m. EST, February 7, 2014

Frozen banana treat business

develops expansion recipe

clip_image002

Mindy and Chuck Pheterson own Totally Bananas which is adding a new product line to its frozen banana treats and raising funds through CircleUp, a crowdfunding site founded by Google Ventures. (Susan Stocker, Sun Sentinel / February 3, 2014)

clip_image004

clip_image006Totally Bananas

Owners try

crowdfunding

to raise cash

By Marcia Heroux Pounds, Sun Sentinel

7:17 a.m. EST, February 7, 2014

Chuck Pheterson has always liked chocolate-covered frozen bananas. Now he really likes them, and so do thousands of others.

Three years ago, Pheterson started a business with his wife, Mindy, making his favorite snack. Business is booming — sales were up 35 percent last year over 2012 — and the Phetersons are looking for even more growth this year from their Totally Bananas venture.

"We're everywhere, from Circle K to The Breakers," Chuck Pheterson said.

The Davie-based business, which leased larger manufacturing space in 2013, would like even more people to enjoy its snacks, which taste almost like ice cream but are dairy-free and gluten-free. So the company has been building awareness both through its own publicity efforts and a recent listing on the crowdfunding site, CircleUp.

Last year, Totally Bananas received an unexpected publicity boost when Netflix ordered 20,000 treats to promote the return of its TV show "Arrested Development," which features a banana stand in its plot.

Videos of the event show a massive line in Times Square for the banana treat giveaway by the show's actors and director Ron Howard. That promotion led to a potential investor responding to the company's recent posting on CircleUp, where the business is seeking $300,000 for expansion.

Crowdfunding sites like CircleUp give small businesses an alternative to financing expansion. Pheterson said he chose CircleUp because the site focuses on consumer and retail products.

Rafael Cruz, who heads the Small Business Development Center in Broward County, said crowdfunding is making financing viable for companies that are just beginning to show major growth and results.

"That's the sweet spot," he said, but also warned that such investments are also risky.

CircleUp, where companies trade equity for investment, said it has helped 32 companies raise more than $30 million. Since its listing two weeks ago, Pheterson said he already has conversations with 15 potential investors.

Totally Bananas has two patents pending on equipment to increase automation and production. The company wants to make small-bite packages of their treats for distribution to discount clubs and other new outlets. New fruit-blended banana treats also are on the drawing board, Pheterson said.

Currently the business has more than a $500,000 in annual sales, employing six workers during its busy summer season.

In recent years, the company has broadened distribution to amusement parks and concessions as far north as Canada with the help of Joel Kornbluth. With a background on Wall Street and in e-commerce, Kornbluth joined the company as a partner in 2010 and handles the company's large accounts.

"We're on a good path here," said Kornbluth, who grew up in Hollywood and was looking for a company to buy when he met the Phetersons through the Davie-Cooper City Chamber of Commerce. "People gravitate toward the product."

New River Groves store owner Bob Roth sells Totally Bananas' products at his Davie store. "I wish I could copy them because they're so good," he said of the treats. "We sell a lot of them."

Other vendors for Totally Bananas can be found at totally-bananas.net/map.

While the company is working on new products, their treats will always contain a banana, said Mindy Pheterson, who handles the company's accounting and marketing.

"We're named Totally Bananas to keep our focus," she said.

mpounds@tribune.com or 561-243-6650

http://www.sun-sentinel.com/business/careers/fl-totally-bananas-expansion-20140206,0,247279.story

Tuesday, February 4, 2014

United Healthcare medical Policy Number: 2014T0101Q–Vagus Nerve Stimulation

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, February 05, 2014 12:49 AM
To: Stephen J. Hemsley - CEO, United Healthcare
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Subject: United Healthcare medical Policy Number: 2014T0101Q

To Joyce’s fellow VNS patients et al.,

The below listed link and attachment is United Healthcare’s recent policy as it relates to VNS Therapy.

United Healthcare medical Policy Number: 2014T0101Q

United Healthcare has denied replacement surgery to an existing VNS Therapy depression patient and then subsequently also denied the patients first appeal.  The patient is now working on a second appeal.

Yet United Healthcare’s Medicare Advantage PPO program paid for two (2) patient replacements, one of those being my spouse Joyce.  At the time United Healthcare’s representative floundered over me to insure that Joyce’s surgery and needs were all taken care of for which I was most appreciative (and thank you too Amy Larrick, CMS).  Now we have United Healthcare’s reversal of care toward a private subscriber payer. 

The decision on the part of United Healthcare and it’s CEO is truly an abomination as well as cruel and goes against CMS informal decision of September 26, 2013.  The lack of humanism and compassion for this patient is unfathomable.  The denial overlooks and does not take into account the most important fact of all; the patient maintained wellness for multiple years and now that the battery has depleted the patient is slipping back into the abyss of a major depressive episode.  This fact, in the case of this patient as well as other existing VNS Therapy depression patients wishing to continue with their therapy contradicts a number of the assessments contained in the United Healthcare medical Policy Number: 2014T0101Q.

UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice.”

Just quickly, what I find of interest right-off-the-bat in this policy is the fact it does not indicate who prepared this policy.  Was it some bureaucrat or youngster sitting in front of a computer making this determination?  Was it a medical professional(s)?  More importantly, was it a medical professional(s) with psychiatric credentials and/or certification?  Was it one of the notorious ghost writers often found preparing research study results or documents of this nature?  Then there is the fact that “UnitedHealthcare reserves the right, in its sole discretion, to modify its Policies and Guidelines as necessary. This Medical Policy is provided for informational purposes. It does not constitute medical advice.”  And yet United Healthcare totally disregards the patient’s highly qualified psychiatric medical professional’s statements as to why the patient requires this therapy.

There will be more to follow as I gather my thoughts and share my facts and opinions based upon what I consider a subjective and flawed policy lacking true understanding of the nature of Major Depressive Disorder (MDD) as explained in United Healthcare medical Policy Number: 2014T0101Q.  The fact the policy discriminates against patients who have obtained multiple-years of wellness and require access to replacement and care to maintain their mental health, general wellbeing and reasonable quality of life goes beyond reason and logic.

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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