VNS Therapy (Vagus Nerve Stimulation)

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From: Kimberly Meek [mailto:k.meek@me.com]
Sent: Wednesday, August 28, 2013 3:58 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy -- D-02 study subject

Dear Herb,

Thanks for the info about the Joyce's replacement pulse generator. I knew that you would know!

You are welcome to share the following publicly…

---

Dear Herb,

Thank you for your hard work and continued support over the years. I have been doing so well that I haven't really kept up with the "goings-on" in the community, which I have been reminded that I should have been doing -- as I am one of those who will most likely be in the catch-22 situation. I was a study participant in the D-02 study.

I can't remember exactly what year I was implanted -- possibly 2005 or 2006. My battery is still functional, but earlier this summer my neurologist/psychiatrist did mention that my battery will wear out in a few years. I haven't asked my current insurance company if they will pay for the surgery, but I seriously doubt they will. My previous insurance company refused to pay for the implant, but I was fortunate enough to be accepted into the D-02 study. It was my last sliver of hope.

It took me about two years to become totally stable after the VNS implant, but I have been stable since then -- at least 7 years (depending upon when I was actually implanted -- I'm not sure what year it was). This is the longest symptom-free period I have had in more than 20 years. No hospitalizations, no ECT, no disability. I'm only on medications and see my psychiatrist every 3 months for med checks. I am a happy and productive (and tax paying!) member of society now. No other medical treatment has worked as well; as long; or with no side effects, as the VNS.

I hope to be able to continue the VNS treatment and have already started saving money for it. I seriously doubt I will be able to save for the full cost of the pulse generator, surgeon and hospital fees, but I'm prepared to take out a home equity loan if necessary. That is how important my VNS is to me. I will risk my home to try to pay for it. And if in a few years I don't have enough saved -- or am not in a good-enough financial situation to obtain a home equity loan -- well, it will be back to expensive hospitalizations, ECT treatments, which often lead to my being disabled. I don't understand why any health insurance company or the US government would be so short-sighted. I also don't understand why Cyberonics (besides corporate greed) would go back on their promise to take care of its study subjects in this situation. As my grandmother would say, "Tacky." Very tacky, indeed.

I don't regret being in the Cyberonics D-02 study. I have been very, very blessed to have had 7 years of being pretty much depression-free thanks to the VNS. I just regret that I'm going to be in a catch-22 situation when my pulse generator battery runs out.

The clock is ticking. I hope someone can do something.

All the best,

Kim

From: KC [mailto:kcsparow@kc.rr.com]
Sent: Wednesday, August 28, 2013 1:34 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Herb,
I have an estimated three years left before I need a replacement, so my case is not nearly as dire as yours. However, I'm facing the same problem.
Regarding the 2nd group on your list....
> Then there are those patients who obtained or fought to obtain the therapy during the window of opportunity between the FDA approval and CMS national decision to decline.
There is a subgroup of patients in that category, and I am a member.
My surgery was approved during that period. I got the implant, and then I was notified that Medicare had decided not to pay for the surgery or the implant, on grounds that it was "unnecessary" in my case. My surgeon was never paid, and for all I know, neither was Cyberonics.
Consequently, Medicare replied to my most recent correspondence by telling me that since Medicare didn't pay for the implant in the first place, it's not obligated to pay for a new battery when the time comes.
I don't know how many implant patients are in my little subgroup, but the distinction is an important one. Will it dilute your efforts if you include us, as well?
Regards,
Kathleen Cruden
(Kat C. in the Yahoo group)

From: Turner, Courtney (CMS/OPE) [mailto:Courtney.Turner@cms.hhs.gov]
Sent: Wednesday, August 28, 2013 2:09 PM
To: Joyce and Herbert Stein
Cc: Schreiner, Daniel (CMS/OPE)
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

You’re welcome.

CST

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 28, 2013 11:42 AM
To: Turner, Courtney (CMS/OPE)
Cc: Sebelius, Kathleen (HHS/OS); Blum, Jonathan D. (CMS/CM); Tavenner, Marilyn (CMS/OA); Schreiner, Daniel (CMS/OPE); Gyles, Lynda (HHS/IOS)
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Courtney,

I can’t thank you enough for coming to our assistance and for directing my various emails containing our pleas to the proper parties within the government. Hopefully these people can fully comprehend our dire needs and the egregious and moral oversight that has taken place in not caring for this small group of patients.

We seek a favorable “Compassionate use” determination.

I am also sharing this correspondence by way of blind copies to a number of patients, physicians, etc. with whom I’ve collaborated with through the years to keep all updated.

What I’ve not included in my previous pleas is a guesstimate on my part as to the number of patients caught up in this Catch-22 situation.

There really are three (3) groups here although two (2) from my viewpoint are the major ones I’m advocating for at this moment:

1- The first group are the study subjects covered by Cyberonics “Lifetime Reimbursement Guarantee”. This encompasses D-01 study subjects (60 patients), D-02 study subjects (235 patients) and D-20 (which I believe was disbanded and there were no implants). Of the 235 patients in the D-02 I believe 13 dropped out of the study before implantation. So we are discussing approximately 282 study subjects. Of that group I estimate that maybe 40% (about 113 study subjects) are choosing retention of the therapy.

2- Then there are those patients who obtained or fought to obtain the therapy during the window of opportunity between the FDA approval and CMS national decision to decline. At one point Cyberonics was issuing weekly numbers of those who did obtain the therapy that way. When my website was hacked I lost the information that I had copied and posted but I would estimate at the most there may have been about 500 patients that Medicare/Medicaid or private health insurance paid for their implantations. I strongly believe Cyberonics should have a record of those patients as they had staff assisting the prospective patients at that time. Using the same 40% retention rate (about 200 patients) is my rough estimate from that group who wish to retain the therapy. The study subjects, totaling about 113 and the other patient group totaling about 200 I would guesstimate about 313 patients in total are the individuals I’m advocating for who are desperately opting for retention. That’s it, about 313 individuals is my guesstimate who are benefiting from the VNS Therapy and who wish to continue with the treatment and be covered by their medical insurance carriers.

3- Lastly, I am also advocating to never allow a similar fiasco (Catch-22) to happen to any volunteer medical study subjects again and to write in on all volunteer medical study contracts that the responsibility of medical care for the study subjects will remain the responsibility of the sponsor until such time as CMS formally determines acceptability of the treatment which from my understanding would simply mean that Medicare/Medicaid and the private health insurance carriers will then reimburse for treatment. Please correct me if I am wrong in my thoughts on this subject.

I am also led to believe that some of your review folks are more the bureaucrats and number crunchers so I’d also like to throw out to them et al. that we are speaking about a group of patients that are obtaining 100% response and efficacy from their VNS Therapy. I’ll repeat, 100% percent response and efficacy. I’ll defy anyone within the medical community to come up with anywhere near a response rate for any psychiatric therapy coming close to that number. Once again, I’ll also remind the number crunchers these are patients who have suffered for decades and have often been referred to as “the worst of the worst” and have cost our health care system untold millions of dollars and through the use of their VNS Therapy have cut those cuts drastically.

I would also like to apologize to Madam Secretary Sebelius as it was brought to my attention that I was improperly addressing her in my correspondence and that she should be properly addressed as Madam Secretary; so noted

I await nervously and with much anxiety for the formal response which you indicated would be forthcoming shortly.

Once again, I am much appreciative for your personal assistance and for me to have the opportunity to speak to a real live person.

Thank you.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Turner, Courtney (CMS/OPE) [mailto:Courtney.Turner@cms.hhs.gov]
Sent: Wednesday, August 28, 2013 10:25 AM
To: Joyce and Herbert Stein
Cc: Turner, Courtney (CMS/OPE)
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Mr. Stein,

Per our telephone conversation, I wanted to send a note confirming what I discussed with you.

Your inquiries have been forwarded to the appropriate CMS component for review. Once the review is completed, you will receive a formal, written response.

If you have any questions, please don’t hesitate to contact me at (410) 786-4593 or email at Courtney.Turner@cms.hhs.gov..

Sincerely,

Courtney S. Turner

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, August 27, 2013 1:05 PM
To: Sebelius, Kathleen (HHS/OS); Blum, Jonathan D. (CMS/CM)
Subject: FW: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Ms. Sebelius and Mr. Blum,

Let me take another opportunity to share with you both another email (listed below) I received again this morning giving me permission to share publicly with you and others the oversight and egregious as well as horrifying predicament you’ve set upon up us. I wonder if the “medical team” is able to codify or quantify these real life issues so that when they “review of Medicare coverage for VNS Therapy” for this group of patients they can truly comprehend the issues as well as the benefits.

Please also take careful note of the young woman’s email citing another example to disqualify and refute Dr. Peter Lurie’s (formerly of Public Citizens) lack of knowledge of psychiatric patients, VNS therapy and his perspectives on “Placebo effect”.

We need either of your signatures on a “Compassionate use” document; now!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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NOTICE OF CONFIDENTIALITY / Disclaimer

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-----Original Message-----
From: KC [mailto:kcsparow@kc.rr.com]
Sent: Tuesday, August 27, 2013 9:39 AM
To: Joyce and Herbert Stein
Subject: VNS therapy

Dear Herb,

Below is a copy of the letter I sent to Craig Malislow.

It's the most succinct summary of my VNS therapy's success that I've been able to write.

Please feel free to send it to anyone who might listen to our story.

Kathleen

-------------------------------------

I was not a member of the study Joyce Stein participated in, but my

quality of life depends on a VNS implant, and the replacement battery

will not be covered by Medicare.

The device changed my life. I have been bipolar since childhood, and by

the 1990s the depressive part of my cycle extended as long as two years.

The effect on my life was devastating to the point where I was legally

disabled (in 1993), and no medication worked for any length of time. By

2006, I ran out of pharmaceutical options, so my doctor prescribed the

implant. We thought it was covered by Medicare, but shortly after the

surgery, I received a letter from Medicare stating that the implant was

unnecessary, and that my surgeon would not be paid.

The implant became fully effective in about two years, as promised by

Cyberonics. Since late 2008, I have been symptom-free. Anyone who

suffers from a lifetime of chronic depression will tell you that the

subject is never far from your mind, and yet, these days, I even forget

to tell people I'm bipolar. Almost the only time I think about it is

when I try to figure out how to replace the battery. I am finally

digging my way out of two decades of disorganized, disrupted thinking, I

have friends that I can enjoy, my writing is about many topics instead

of limited to my depression.... Life is very good right now, and for the

first time in my life.

I can say those things in all honesty, in spite of the fact that I am

still suffering from fibromyalgia. My life is that good.

My worst fear is that in three years, my battery is going to die and I

will have to return to those dark days. I have begun approaching my

senators' offices, looking for help in changing Medicare's policy. The

first round of contact with Medicare netted me a letter that confused

VNS implant therapy with stem cell research. It's going to be an uphill

battle.

Much depends on Herb and Joyce Stein's ability to get Medicare coverage

for Joyce's implant.

I'm grateful for your interest in their story. If you want to talk to me

about my experience with VNS therapy, please feel free to respond to

this e-mail or call me at the number below.

Sincerely,

Kathleen Cruden

518 Maier Dr.

Belton, MO 64012

816-719-4508

P.S.: There are three additional details that might interest you.

1) I am currently the only VNS patient at Pathways Community Health,

Raymore, MO. Elaine Boyd, who manages my device, is one of several

professionals who have told me that they have other patients who would

benefit from VNS therapy but can't get coverage for the implant.

2) Within four months of the implant surgery, I had to begin weaning

myself off the gabapentin and lithium that I'd been taking for years.

The reason? The implant had begun to compensate so well for

pharmaceutical meds that I was beginning to experience symptoms of

over-medication. I can't remember the cost-savings to Medicare D, but it

seems to me it was in the vicinity of $500 a month. Or $900. Gabapentin

is pretty expensive.

More recently, I had to stop taking Provigil. I had been taking it since

2009, originally for ADD symptoms, and later because I have sleep apnea

and needed help staying alert during the day. But early last year, the

Provigil became too effective, and I had to request that I be weaned off

it as well. My dose went from 400mg daily to a suggested 50 - 200mg a

day as needed, but I seldom take even that small dose.

The cost savings to Medicare D is $1200 a month.

3) I don't know how many implant recipients are now fully employable.

But I do know that if I wasn't dealing with the fatigue and cognitive

problems associated with fibromyalgia, I could be a tax-paying citizen

again. As it is, I am able to be productive in my home at a rate that

was formerly out of the question.

I owe a lot to VNS therapy, and so does Medicare.

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, August 27, 2013 5:15 AM
To: Jonathan Blum; Kathleen Sebelius
Subject: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Mr. Blum,

It is extremely difficult for me to contain myself and at the same time to be respectful as a hands-on support person and health care advocate to my spouse Joyce for 50 years to simply sit quietly while Ms. Sebelius and you waste precious time to speak in bureaucratic terminology such as “Patient perspectives”. Passing my previous email to your “medical team for their ongoing review of Medicare coverage for VNS Therapy” is nothing more than further wasting time and bureaucratic speak lacking any true understanding of the desperate needs of these patients to continue their wellness while saving the government significant sums of health care monies.

With all due respect to you, your medical team, Ms. Sebelius and her team(s) and Mr. Dan Moore of Cyberonics and his team(s) I doubt any of you have any hands-on experience caring for anyone of this unique population of patients. I truly wonder if any of your “medical team” has any psychiatric certifications and/or tended to any of these patients. How in the world can you possibly understand the dire needs and situation you have put these study subjects and implanted patients in, who are doing well, and forcing them back into the depths of despair and suicidal ideations?

Did you or Ms. Sebelius every take the time to read some of the 200 or more comments from the psychiatric professionals during the writing period to CMS some 7 years ago? Did you take the time to understand that these physicians were seeing incredible responses from their hands-on experience with patients that were given up as “hopeless”. That is patients suffering for decades having exhausted all the conventional treatments as well as numerous yearly hospitalizations and suicide attempts and well as enormous costs to our health care system finally responding to a treatment. Does that information appear before your number cruncher “medical team” to understand? Psychiatric professionals and KOL’s telling you that a number of their hands-on patients were finally responding to a therapy. Did you also consider that the D-02 double-blind study was improperly established based upon 12-week drug protocol studies? I know you and your team(s) do realize this is a medical device and not a drug and at the time one of the newest neuro-modulation therapy for depression. I gather Medtronics and St. Jude have used Cyberonics as a case study in what not to do.

The problem here is not my perspective. I deal in 50 years of observations, facts, reading and research as well as collaboration with patients who have and have not responded to the therapy. It is your perspective as a bureaucratic and that of your team(s) looking at numbers and trying to cut and/or save monies without getting down and dirty to really evaluate the effects of your decisions on real live people or whether your decisions are truly beneficial to the health of our citizens or whether you’re really cost savings by your decisions are the bigger questions. By the way, please don’t allow your team to bring up the issue of safety as you should well know the therapy is both FDA and CMS approved for Epilepsy. The very same therapy for which I’m requesting “Compassionate use” for the existing implanted depression patients.

Once again I’ll give you information and leave perspectives to you and all your teams. My spouse suffered MDD for some 36 years. At the moment I don’t remember the exact number of multiple hospitalizations she had during that period of time and the costs of all the hospitalizations, sometimes 2 to 3 weeks at a time. I don’t remember the number of ECT she had although I could go back on my records to pull up all these numbers. 36 years of multiple drug therapies failures. Doctor visits, often weekly for years at a time to try to keep her going. I’d strongly guesstimate the yearly medical bills totaled in the tens of thousands of dollars each year.

With the advent of VNS and her participation as a study subject she’s had no hospitalizations in over 10 years, no antidepressant medications, quarterly visits to her psychiatrist and 9 years on her current and second VNS pulse generator due to expire shortly.

One does not have to be a genius to understand and compute the savings to Medicare/Medicaid of the VNS Therapy for my spouse and other implanted patients similarly benefiting and saving CMS.

What does it take to humanize Ms. Sebelius or you that by the stroke of a pen to grandfather care for these patients under “Compassionate use” that these people can continue on with their lives without pain or anguish and possible death as well as saving the government on their health care needs and costs?

Does one have to genuflect before you folks to have you comprehend the gravity of the situation you have put us in? Life would have been much simpler had the FDA denied approval. Cyberonics would remain responsible for the study subjects care. Prospective patients would not have been able to obtain the implant funded by Medicare/Medicaid coverage during the window of opportunity between FDA approval and the national denial by CMS would have been a non-issue. The fact is you didn’t provide for the study subjects and gave hope by paying for other patients. And now you simply turn your back and talk to me about perspectives?

You folks and all your teams are guilty of lack of forethought by not caring or thinking about these study subjects and patients when making your ruling. I speak using facts and you speak about perspectives.

I’ll give you another point to consider to save Medicare/Medicaid monies. Force Cyberonics to care for their study subjects as stated in their “Lifetime Reimbursement Guarantee”. Obtain a decision from the OIG that there is no kickback statues as Cyberonics alleges and/or alludes to. The study subjects will pick the hospitals, surgeon, anesthesiologists etc. for their replacement surgeries would then negate any collusion on the part of Cyberonics and represents an arms-length-transaction. All that Cyberonics would be responsible for is to pay the bill as stated in the aforementioned document. Then Medicare/Medicaid and/or the health insurance carriers would only be responsible for those patients they previously covered. Does anyone think least of all think out-of-box?

I apologize if I’ve offended any of your folks by my determination and writings but I simply do not know how else to politely get my message across. You’ve all wronged my spouse and the other study subjects and patients who wish to continue with the therapy. In my mind you all play your political, bureaucratic and corporate games by not taking responsibility for the egregious and unconscionable acts perpetrated against these patients that can easily and with cost savings be resolved by “Compassionate use” and the stoke of one of your pens.

I would also implore all the physicians and patients who I blind copy in my communication to not sit by silently. To the physicians share what is going on with colleagues and express your personal experiences and knowledge with Mr. Jonathan Blum and Ms. Kathleen Sebelius. To the patients please share your experiences and why you want to continue with the VNS Therapy. Mr. Blum and Ms. Sebelius from my readings and research are capable by the stroke of either of their pens to issue a “Compassionate use” decision.

Lastly, I have this early morning hour just been given permission by a young woman who is another VNS patient who has benefited from therapy. Your teams are also torturing this young woman and attempting to send her back to “The Black Hole”. I’ve copied and pasted her communication below. It is a fact. Not a perspective.

What does it take to make you folks understand our dire needs, your oversights and the consequences of you people not acting promptly and responsibly?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

From: Amy <keyanote@gmail.com>
Date: August 27, 2013 1:43:55 AM EDT
To: "craig.malisow@houstonpress.com" <craig.malisow@houstonpress.com>
Subject: Cyberonics Vagus Nerve Stimulator for treatment resistant depression

Craig,
I understand you may be interested in stories from people who have a vagus nerve stimulator for treatment resistant depression and now that Medicare will not cover the cost we are out of luck with the only treatment that ever worked for us.
I am so frustrated and feel myself falling back into the "black hole" Herb spoke of in his letter further and further everyday. In March of 2013 I had my battery replaced. It was a $34,000.00 surgery. I was fortunate to have a very caring surgeon that lead me to the hospitals financial department where they had grants that covered all but $550.00 of the surgery. In June I started feeling depressed and then had some odd symptoms with the stimulator and have found out that it is not working properly so it had to be shut off. There could be something wrong with one of the lead wires or there may be scar tissue formed around the wires. They cannot tell by the xray. My surgeon is a general surgeon and for complications with the device has to refer me to a neuro surgeon.
Medicare will not pay to find out or for the surgery to fix it. So now I just have to live without it. The $34,000.00 that was gifted to me in March was wasted.
I don't understand why the one thing that helped me cannot be covered. I have attempted suicide multiple times. I have been on almost every depression medication out there. I have done Ect therapy. Nothing helped me like the Vagus Nerve Stimulator.
I don't know what my future is going to be like now. I can't imagine going back to the life I used to live but I am slipping back and there in nothing that can be done.
Sincerely,
Amy Lasko

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, August 19, 2013 12:44 PM
To: 'Blum, Jonathan D. (CMS/CM)'
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Mr. Blum,

Thank you for taking your valuable time to acknowledge receipt of my communication. I do hope you took the time to read and understood the gravity of my message.

Your medical team has twice denied depression coverage without consideration for those study subjects and patients already implanted and benefiting from the therapy as is my spouse. That fact is unconscionable and immoral.

My email is not a perspective but a desperate call for help. We are in need of a compassionate dispensation ruling.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Blum, Jonathan D. (CMS/CM) [mailto:Jonathan.Blum@cms.hhs.gov]
Sent: Monday, August 19, 2013 12:22 PM
To: Joyce and Herbert Stein
Subject: RE: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Mr. Stein,

Thank you for your letter. I have passed this on to our medical team for their ongoing review of Medicare coverage for VNS Therapy. Patient perspectives are invaluable to our review process.

Sincerely,

Jonathan Blum

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, August 17, 2013 2:30 AM
To: Blum, Jonathan D. (CMS/CM)
Subject: VNS Therapy (Vagus Nerve Stimulation) the egregious oversight by CMS endangering the lives of study subjects and patients...

Dear Mr. Blum,

Does anyone within CMS have a moral consciousness?

You folks amongst several other parties have created a serious and potentially life-threatening issue. And to boot you’ll cost Medicare/Medicaid more money as a result of your egregious oversight and lack of forethought.

My spouse Joyce volunteered and contracted to be a medical study subject for the newest neuro-modulation implantable therapy for depression at the time. VNS Therapy (Vagus Nerve Stimulation) sponsored by Cyberonics Inc. The indication was FDA approved which then relinquished the sponsor of any further responsibility for patient medical care. The indication was later denied by CMS in a national determination document. Despite CMS national coverage denial the therapy has proven remarkably beneficial for my spouse and other study subjects as well as a few patients who were able to acquire the device through Medicare/Medicaid during the brief window of FDA approval and subsequent CMS denial. Despite the fact we have health insurance through a United Healthcare Advantage PPO we cannot obtain reimbursement for care, services or replacement for this indication. The lack of forethought by CMS to not grandfather coverage for these study subjects and those already implanted, doing well and wishing to continue the therapy is unconscionable and has left us in no man’s land and worse yet is the stress and anxiety I’m experiencing at the thought of my spouse nose-diving back into suicidal ideations.

I will also point out to you the very same therapy as you well know is FDA and CMS approved for epilepsy.

In the egregious and serious oversight CMS did not provide or grandfather care for this small group of patients who are for years doing well. In turn they are saving Medicare/Medicaid tens of thousands of dollars yearly in hospitalizations, care, medications, doctors etc. costs as a result of their wellness and now face returning to “The Black Hole” from which they emerged after decades of suffering and anguish as well as multiple suicide attempts. This small group of study subjects (my spouse Joyce included) and other patients implanted with the device are doing well and want to continue with the therapy and will need replacement when their batteries deplete. They are being denied medical care and health insurance coverage by CMS, private health insurance carriers and Cyberonics.

I speak to you “mamaloshen” a term you might well be familiar with. I am asking or really pleading for your help whether it be you or someone else in authority to understand our plight to make a compassionate dispensation or whatever appropriate terminology you folks use to see that these people maintain their wellness and stay off the public dole.

I also bring to your attention that early on I became aware of this possible oversight and loophole. I communicated my concerns to the sponsor (Cyberonics). The whole story I hope is clearly covered in my petition listed below with reference links to information and documents. One such document was issued by Cyberonics (Lifetime Reimbursement Guarantee) which I’ve attached. Cyberonics has reneged on that guarantee. The current CEO, Dan Moore cited “kickback statue” which I strongly opine is a sham excuse. I cover that recent dialog in a separate email to follow once you grasp the dire emergency situation these patients and my spouse find ourselves in through none of our fault.

Please feel free to contact me any time, day or night, as I am working with little sleep trying to get our message heard and acted upon responsibly and compassionately.

Jonathan, please confirm receipt of this communication so that I know at the very least you did receive our plea for help. Thank you.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

Caution: Do not volunteer for any medical research until you read this petition.

VNS THERAPY FOR DEPRESSION (VAGUS NERVE STIMULATION)

The Petition:

The purpose of this petition is quite simple and straight forward, that is to obtain medical care and/or health insurance coverage for a group of volunteer medical study subjects for an FDA (Food and Drug Administration) approved therapy and to warn all medical volunteer study subjects to obtain in writing who is responsible for their medical care if CMS (Centers for Medicare and Medicaid Services) and/or one’s own insurance company denies coverage.

FDA approval does not mean or insure medical care or health insurance coverage.

Background:

On or about 1997 Cyberonics, Inc. received FDA approval for VNS Therapy for Epilepsy. On or about 1998 Cyberonics additionally got the go ahead to institute an open pilot study (D-01) for the same VNS Therapy for Depression. The D-01 was instituted as a result of Epilepsy studies and patients not only reporting decreases in number and severity of their seizure activity but also diminishing depression episodes.

Through the assistance and caring of my spouse’s then attending psychiatrist, Dr. Paul Goodnick, Joyce was enrolled in the D-01 open study as study subject #46 at MUSC (Medical University of South Carolina) under the directorship of Dr. Mark George and Dr. Ziad Nahas. She was implanted with the device on December 13, 1999.

In our desperation at the time and after some 36 years of Joyce’s continuing severe depressive episodes and suicidal attempts and failed therapy trials as well as numerous ineffective medications and refractory treatments, she signed the papers for this newest neuro-modulation study.

We carefully noted that death was a possible outcome. We also noted once FDA approved, Cyberonics would no longer be responsible for her medical care.

What we didn’t know or realize at the time of signing nor did any of the study volunteers and worse yet the fact that all the other affiliated parties and medical professionals didn’t take into consideration when structuring any of these depression studies that with FDA approval it ended Cyberonics responsibility for medical care but it did not insure Medicare/Medicaid and/or health insurance coverage for the study subjects. Nor did anyone know despite FDA approval that CMS would deny coverage for this medical device (historically the first time such an event took place) left these volunteer patients in a Catch-22 with an implanted medical device and no one willing or responsible to pay for medical care despite some of the study subjects with paid up health insurance but still denied coverage for this particular therapy.

VNS Therapy, VNS depression studies, Cyberonics, the former CEO Robert P. (“Skip”) Cummins and the FDA have all been steeped in controversy and maligned as well. Yet and at the time, when I brought this loophole to the attention of Mr. Cummins he assured me “not to worry.”

Mr. Cummins honored his words and to his credit, took action and made a responsible and morally correct pronouncement. He acted and assured the depression study subjects would have health coverage for the VNS Therapy if their own health insurance and/or Medicare/Medicaid carriers denied to cover the therapy by publicly announcing on January 18, 2006:

“Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15 Million TRD Indigent Care Program…Cyberonics has taken the unprecedented steps with its lifetime reimbursement guarantee for study patients and its $15 million TRD Indigent Access Program, to ensure that study patients and indigent Americans with TRD have fully informed access to VNS Therapy.”

Similar information was also entered into the Cyberonics corporate 8-K SEC filings.

Mr. Skip Cummins is no longer with Cyberonics and the current management has reneged upon their oral and published contract, commitments and statements. The company has refused to pay for the servicing, care and replacement of their implantable devices for those volunteer study subjects (patients) wanting to continue the therapy.

A number of these volunteers, who were devastatingly ill, are benefiting long-term and living reasonable quality of lives as a result of VNS Therapy. These patients are being denied health insurance coverage by their own paid for carriers as well as Medicare/Medicaid despite the fact the therapy works for them and was FDA approved.

Adding to the illogic of this conundrum is the fact the very same therapy is covered by Medicare/Medicaid and health insurance carriers for epilepsy and that some 200 leading psychiatric professionals had commented during the write-in period to CMS that the therapy should be approved for coverage based upon their personal patient treatment experiences and that conventional therapies are ineffective for this unique population of seriously ill patients.

In the infinite “lack” of wisdom on the part of our government’s convoluted working agencies to protect us the FDA, CMS as well as the sponsor and the oath taken by all the medical researchers (to do no harm) no one thought to ask or provide for health care and replacement coverage for these medical volunteers. Thereby leaving these study subjects (my spouse included) with a costly implanted medical device and therapy that no study subject rightfully or morally should be paying for out-of-pocket especially since we have health insurance.

CMS in their denial of coverage should have rightfully grandfathered in the existing study subjects. They did not.

One last and most important point; Joyce and I still remain advocates for VNS Therapy for Depression as a potentially viable treatment option to be considered by a reasonably informed patient.

As a result of this therapy my spouse has been depression free approaching 14 years. We no longer discuss depression. She takes no antidepressants. Our major concern is to continue maintaining her past 14 year wellness utilizing the same VNS Therapy and to have our paid for health insurance carrier, Cyberonics and/or any other responsible party honor their commitments to cover Joyce’s medical expenses and that of the other study subjects as they do for epilepsy.

At the same time to once again caution and make aware to other volunteer medical study subjects in any other kind of study to not get caught up in a very stressful similar and costly situation and negligent oversight.

Conclusion:

Please sign and join this petition to correct this medical injustice:

I am requesting The United States President, Senate, Congress, CMS, state and local governmental officials, Health Insurance Industry, Cyberonics and all medical professionals especially those having anything to do with VNS Therapy for Depression to do the responsible and morally correct thing by exerting pressure upon any of the responsible parties to correct this oversight and injustice by helping these volunteer study subjects (patients) to obtain medical coverage and to insure future medical study volunteers are not faced with a similar predicament.

Thank you all for your consideration in reading this petition and joining in to obtain health care for all medical research study volunteers.

Sincerely,

Herbert Stein, caregiver and long-time support person to my spouse, Joyce Stein