I met with Congresswoman Debbie Wasserman Schultz and her Senior Congressional Aide

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, August 30, 2013 3:35 AM To: Vivian F. Piereschi, Senior Congressional Aide to Congresswoman Debbie Wasserman Schultz

Subject: VNS (Vagus Nerve Stimulation) – Request for favorable “Compassionate use” decision…

Dear Vivian,

It was very nice meeting you yesterday at the YMCA and for taking the time to chat with me.  I’m only sorry I didn’t remember Rene Smoley encouraging me earlier on to contact you.  Anyway, I did finally meet you and gave you my letter of advocacy for which I thank you.  I briefly spoke to Debbie and I told her I gave you the initial information.

We are in urgent need of Debbie’s advocacy in obtaining for us a favorable “Compassionate use” decision from either Madam Secretary Kathleen Sebelius or from Jonathan Blum at CMS.

I am not only an advocate for my spouse Joyce but also for a small group of former volunteer medical study subjects and patients already implanted with a VNS (Vagus Nerve Stimulator) for depression.  These patients are all benefiting from the therapy and saving our government substantial sums of money as they are no longer suffering severe depression and have far less medical needs and expenses as they once did suffering decades of major depression.  This therapy was FDA approved but subsequently denied by CMS.  Yet the very same therapy is CMS approved for the epilepsy indication. 

One statistic I am trying to impress upon these bureaucrats is that 100% of this group is finally responding to a therapy and maintaining efficacy over unprecedented time period which is unheard of by way of psychiatric therapies.

Joyce’s pulse generator containing the battery is soon to expire.  She is on her second pulse generator approaching 9 years.  The two previous pulse generators were implanted and covered under the research study program.  Once the FDA approved the depression indication the sponsor was no longer responsible and for the first time ever a medical device FDA approved was declined by CMS leaving all the study subjects and those implanted after the FDA approval out in the cold in a Catch-22.  No one will take responsibility for health insurance coverage for replacement, care and/or ex-plantation.

Here is the link to my website containing much of my correspondence to HHS and CMS as well as the sponsor Cyberonics, Inc. as well as the background for this egregious and morally reprehensible oversight upon the part of the sponsor, FDA, all the medical professionals who designed the study and created this loophole as well as CMS ineptitude or lack of concern to grandfather care for the study subjects and patients who obtained the therapy before the formal denial from CMS.

Here is my link to the petition I originally started which should give both you and Debbie a better understanding of our plight.  That petition has grown to now encompass all the existing implanted depression patients who are doing well and wish to continue the therapy.  My guesstimate is about 300 to 500 depression patients.

From a humanitarian standpoint I’ve culled out a couple of patient emails that I was allowed to share publicly and have copied and pasted the contents below.  These patient statements stand very well on their own and are the reasons we are desperate and asking for your help.

Vivian, I am at this advocacy full time, both day and night with little sleep.  We are desperate and dread the thought that Joyce wakes up one of these mornings and enters back into the despair that she’s last known about 13 years ago.

Please help us.  I am available to discuss and share information at any time.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

https://vnstherapy.wordpress.com/

 

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)

 

—–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: 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

—————————————————————

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From: Piereschi, Vivian [mailto:Vivian.Piereschi@mail.house.gov] Sent: Tuesday, September 03, 2013 10:53 AM To: ‘Joyce and Herbert Stein’ Subject: RE: VNS (Vagus Nerve Stimulation) – Request for favorable “Compassionate use” decision…

Hi Herb,

Thank you for the information regarding Vagus Nerve Stimulation.  I have forwarded your inquiry to the Centers for Medicare and Medicaid Services. I will be back in touch once I receive a reply from the agency.

Best regards,  

Vivian Piereschi

Senior Congressional Aide

Office of Congresswoman Debbie Wasserman Schultz

10100 Pines Blvd.

Pembroke Pines, Florida 33026

(954) 437-3936

(954) 437-4776 fax

Please note:  In order to better serve you, our scheduling process has changed.  Please submit all scheduling requests online at: http://wassermanschultz.house.gov/scheduling

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About vnstherapy

I'm a very, very long-time support person and health care and mental health advocate/activist for my spouse Joyce as well as to others. I'm also a retired business executive and former Board Member, President and facilitator of a local chapter of DBSA as well as a Florida State appointment as a Guardian Advocate. I do not endorse, promote or advertise for any therapy, product or company. I do share our personal experiences, my research and knowledge in the hope it might benefit someone or do I give advice as to what one should or shouldn't do. I extend my best wishes for wellness to one and all and all the good you’d wish for yourselves.
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