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Wednesday, March 26, 2014

Transcranial Magnetic Stimulation Offers Hope for Patients with Intractable Depression

MDNews

Transcranial Magnetic Stimulation Offers Hope for Patients with Intractable Depression

 

By: Jennifer Webster
Monday, March 24, 2014
Filed under: Medical Devices | Technology | Treatments & Techniques | Psychiatry

NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy, an FDA-approved, nonpharmacologic method of neuromodulation, lifts depression in a number of people for whom medical management has failed.

Photo: Martha St. John, MD, FAPA, uses the Neurostar TMS Therapy System.

Although the FDA approved the NeuroStar TMS Therapy System in 2008, only about 12,000 patients have received treatment so far, though one in 10 people in the United States takes antidepressant medications.

“This therapy slid under the radar,” says Martha St. John, MD, FAPA, who practices at Progressive Psychiatry TMS Center. “Many psychiatrists, not to mention primary care providers, do not understand TMS’ utility and where it fits into the treatment algorithm.”

Major depression takes a large toll on patients in the United States, accounting for $34 billion in absenteeism and other workplace costs, increasing mortality rates in people with other illnesses, and greater likelihood that people will commit suicide.

Unfortunately, depression remains untreatable in many cases. Only about half of patients respond well to the first antidepressant they try; after that, success rates decline to 25–30 percent with the second medication and even lower with subsequent prescriptions. TMS offers an effective alternative.

“It is exciting to offer a treatment that is so novel and actually works for a population of people suffering from major depression who do not benefit from traditional medical management.”
— Martha St. John, MD, FAPA, psychiatrist practicing at Progressive Psychiatry TMS Center

In a large-scale study by Neuronetics, NeuroStar’s manufacturer, 62 percent of patients with treatment-resistant depression experienced relief from their depression after completing TMS therapy, with 41 percent of those experiencing total remission. These numbers remained stable and even improved over time, with 68 percent of patients enjoying greater freedom from symptoms and 45 percent of those experiencing remission 12 months following completion of therapy.

“When I investigated NeuroStar TMS Therapy, I was very attracted to it as a way to benefit my patients,” Dr. St. John says. “There is a tremendous need to expand our options for treating depression. With efficacy exceeding what we can expect from medication in most cases and minimal side effects, TMS looked extremely promising.”

The Science of TMS

Neuro Star 250

TMS uses electromagnetic induction to depolarize neurons in the dorsolateral prefrontal cortex (DLPFC). An electrical current passed through a coil generates a magnetic field, and a current generated in the opposite direction transforms the magnetic field into an electrical field within the DLPFC. The electrical field causes nearby neurons to release neurotransmitters, such as dopamine, norepinephrine and serotonin.

“One way to put the neural circuits back in balance is chemically with medication,” explains Dr. St. John. “Alternatively, because the brain is basically a large circuit, we can activate the outside 2 to 3 cm of the prefrontal cortex magnetically, then utilize the brain’s natural circuitry to stimulate more distal regions, such as the anterior cingulate cortex and amygdala.”

The process continues during and between sessions, which typically last about 40 minutes and are repeated regularly from four to six weeks, for an average of 30 sessions.

Side effects of TMS are quite rare, but this therapy does have the potential to produce mania in people with bipolar disorder. The only contraindication to TMS therapy is presence of an implanted metallic device within 30 cm of the treatment coil. It is not recommended for patients who have seizure disorders, are pregnant or are very elderly.

The patient experience reflects the simplicity of this noninvasive technology. After a first session to establish dosing, patients come daily for a month to a month and a half, spending just over half an hour sitting comfortably for treatment. They do not need sedation or protective equipment, apart from earplugs, and they are able to drive themselves home after each session. They may experience a headache or scalp discomfort.

All of her patients express gratitude for the opportunity to receive TMS therapy, Dr. St. John says.

“Every patient would do it again or recommend it to someone else,” she says. “We have had an overwhelmingly positive response.”

The high rate of anecdotal satisfaction echoes the experience of other clinicians and their patients, Dr. St. John adds.

“An NIMH [National Institute of Mental Health] study confirmed that about 30 percent of patients with medication-resistant depression achieve remission with TMS, but experientially, it’s higher,” she says. “Psychiatrists believe this is because, while patients were withdrawn from their medications before undergoing TMS for research purposes, the common practice is to use TMS as augmentation to medications, rather than replacement. We commonly obtain much better results than are published.”

Make the Connection

Martha St John 175
Dr. St. John practices at Progressive Psychiatry TMS Center.

The longer depression lasts, the less likely it is to respond to treatment. Dr. St. John encourages referring primary care physicians, counselors and others who have patients struggling with depression to consider early referrals.

“We would like to help patients early in their illness ,” she says. “Patients who have tried one to three antidepressant medications at a reasonable dosage and duration but have not had a good response or have experienced intolerable side effects are good candidates for TMS.”

Patients who come to Dr. St. John’s practice, Progressive Psychiatry TMS Center, will find an experienced staff ready to assist them in obtaining insurance coverage for their treatment. In fact, Texas’ Medicare contractor, Novitas, has covered TMS since December 2013.

“Depression is a pervasive illness, affecting 14 million people in the United States,” Dr. St. John says. “We all know someone or treat someone whose life has been touched by it. Unfortunately, a lot of patients are receiving inadequate treatment. We need to treat depressed patients more aggressively. NeuroStar provides hope even for treatment-resistant patients. When TMS is considered earlier in the treatment algorithm, it allows patients to improve their quality of life much sooner.”


To refer a patient to Progressive Psychiatry TMS Center, visit www.doctorstjohn.com or call 281-987-5036.

MD News February/March 2014, Houston Edition


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1 comment for “Transcranial Magnetic Stimulation Offers Hope for Patients with Intractable Depression”
  1. Gravatar of Herbert SteinHerbert Stein

    Posted Wednesday, March 26, 2014 at 1:47:23 PM

    To Whom It May Concern:


  2. As a very, very long-term support person and mental health advocate/activist for my spouse I would like to address an important point missing from this and similar articles.


  3. While this treatment option has also been FDA approved as was VNS (Vagus Nerve Stimulation) Therapy what you all seem to omit and not address and what is most important to the patient and/or his/her support persons is the fact that CMS (Centers for Medicare and Medicaid Services) has not approved national coverage. At best TMS is covered by Medicare/Medicaid and private health insurance carriers on a spotty basis. In the case of VNS, although this treatment option was FDA approved in 2005, it was declined by CMS on May 4, 2007.

  4. I should know as I have been battling CMS and the private health insurance carriers to at the very least cover the original study subjects for VNS Therapy and all those who obtained implants on or prior to May 4, 2007. This has been an egregious, immoral and discriminatory oversight on the part of government to allow these patients to be implanted with medical devices and then refuse medical coverage for these seriously ill patients who responded and obtained efficacy from this treatment option. It has been a major struggle on my part to make any advances and one which the various medical associations and physicians should join forces to overcome.


  5. So what good is VNS at a cost of about $58,000 or TMS at a cost of about $10,000 to $15,000 out-of-pocket to the patient if the health insurance companies and Medicare/Medicaid will not pay and the patient cannot afford the therapy?


  6. You folks want a story to write about? I’ll give you a story to write about; available FDA approved treatments denied by CMS and the health insurance industry that patients cannot afford.

  7. Sincerely,
    Herb

  8. 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

http://www.mdnews.com/news/2014_02/tms-offers-hope-for-patients-with-intractable-depression.aspx

Wednesday, October 30, 2013

In the words of Paul Harvey..."Now you know the rest of the story."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, October 30, 2013 3:29 AM
Subject: In the words of Paul Harvey..."Now you know the rest of the story."

To Joyce’s fellow patients and all those who have helped our cause and encouraged our advocacy,

Joyce’s VNS replacement surgery on October 7, 2013 was absolutely uneventful except for our struggle to finally achieve that goal.  She was up and about immediately after the surgery without any need for pain medication.  We had a follow up with her neurosurgeon, Dr. Bedih Adada.  Her incision is also healing well and we’re back to our normal life’s routines.  We met with her attending psychiatrist, Dr. Ely Pelta for her regular quarterly visit.  He interrogated her device and all is A-OK and we should maintain course hopefully for the next 5 to 10 years.  Depression is absent from any of our discussions; truly amazing.

The major sadness in our lives at the moment is the fact that three friends were all hospitalized previous week and one of those friends sadly passed away.

One of my precepts is to always leave’em laughing to which I add a closing chuckle to this lengthy advocacy.  I yesterday received a letter from the office of Congresswoman Debbie Wasserman Schultz with an enclosure from a Ms. Cherie Weatherington, CMS in Atlanta, GA which I’ve shared with you below.  I thought you might find it funny after all that we’ve been through.   I’ve also shared my subsequent reply to both parties.

Once again, I’d like to sincerely thank Jonathan Blum – CMS, Ms. Amy Larrick – CMS,  Ms. Courtney Turner – CMS and the other governmental folks who finally understood our dire, compassionate and moral needs to correct the egregious and negligent oversight of originally denying medical coverage to this group of patients.

I have received a number of emails from physicians attending to this patient population thanking me for my efforts on behalf of their patients as they now can proceed to help their patients.  I’ve also received emails from other physicians directing their patients to me who were unaware of what has transpired and they too are now advocating on their own behalf to obtain replacement prosthesis.  I’ve been informed that Cyberonics is making an effort to have their representatives who call upon the psychiatric physicians as well as their nurse case managers to assist our unique patient population in obtaining care, replacement and/or ex-plantation of their devices for patients implanted on or before the May 4, 2007 decision.

In the words of Paul Harvey..."Now you know the rest of the story."

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

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

Voice: (954) 349-8733   Fax: (954) 349-8734

fabrik@bellsouth.net

October 30, 2013

Congresswoman Debbie Wasserman Schultz

10100 Pines Boulevard

Pembroke Pines, FL 33026

Dear Debbie,

Thank you for your effort on our behalf.  Apparently Vivian may have overlooked the email(s) I forwarded to her indicating we have achieved our goal.  Also apparent from the letter you received from Ms. Cherie Weatherington of the Atlanta, GA office of CMS she had not received any communication(s) to the fact that after four months of our efforts and numerous emails as well as several telephone conversations with Mr. Jonathan Blum, Deputy Administrator and Director for CMS and Ms. Amy Larrick, Senior Advisor to the Principal Deputy Administrator that a decision was made to assist those VNS patients implanted on or before May 4, 2007 to help insure they receive health insurance coverage for care, replacement and/or ex-plantation of their medical prosthesis.

This decision has corrected the egregious, moral and negligent oversight to have grandfathered care for those patients already implanted on or before the May 4, 2007 national denial.  I would suggest Ms. Cherie Weatherington carefully read the following link and if there is any doubt in her mind to please call Ms. Amy Larrick as stated in the link:

http://www.vnstherapy-herb.blogspot.com/2013/09/vns-therapy-for-depression-good-news.html

My spouse, Joyce, received her replacement prosthesis on October 7, 2013 and is doing very well.  Other patients have also received their replacements and/or are now scheduling for surgery through the assistance of Ms. Larrick at CMS and hopefully will have their procedures covered by Medicare/Medicaid and/or private insurance.

Once again, thank you and thanks to Vivian for trying to assist us.

Sincerely,

Herbert Stein

Cc: Cherie Weatherington, Acting Associate Regional Administrator

Monday, October 7, 2013

It’s over! It’s done!

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, October 07, 2013 11:13 AM
Subject: It's Done!

Yogi Berra, “It ain't over till it's over.”  Herb Stein, “It ain’t done until it’s done.”

 

It’s over!  It’s done!

 

Surgery was this morning.  It was less than an hour and uneventful.  Joyce is in no pain.

Here’s another curve ball thrown in last week for good measure to add to the stress and anguish we’ve already endured.  Joyce was scheduled for VNS replacement surgery Wednesday, September 25, 2013 at Cleveland Clinic, Weston, FL.  It was cancelled by the hospital. 

I immediately went back into battle mode with the executives at that facility as well as their corporate executive offices in Cleveland, OH.   More bureaucratic gibberish to listen to and overcome.

Forget the details, surgery has successfully and uneventfully been accomplished this morning.  We finally achieved our goal.  Joyce is doing very well.

My concluding thoughts on this 4 month 24/7 struggle to follow later once I calm down and debrief from all that has transpired.

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://vnstherapy.wordpress.com/

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Saturday, September 28, 2013

VNS Therapy for Depression - GOOD NEWS

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, September 28, 2013 8:48 AM
To: Amy Larrick (CMS/CM); Jonathan Blum, Deputy Administrator Director - CMS
Cc: Madam Secretary Kathleen Sebelius - HHS
Subject: VNS Therapy for Depression - GOOD NEWS

To all of Joyce’s fellow implant patients,

I’d like to share some very good news with y’all.  I am tardy in my distribution of this news.  To add to all my challenges my computer hard disk is malfunctioning so I’m limping along as best I can until I receive my new computer and get back up to speed.

In any event I wish to relate the following.  Thursday, September 26, 2013, I spoke with Ms. Amy Larrick | Senior Advisor to the Principal Deputy Administrator | Centers for Medicare & Medicaid just before she was leaving on vacation.  Our telephone conversation was “On the record” but I was asked to not record the conversation or to quote directly from what was stated.  Once again, I shall honor that request.  Therefore I shall share my understanding and interpretation of what was presented to me. 

Mr. Jonathan Blum, Ms. Amy Larrick and others members of CMS, in my opinion, are understanding and compassionate of our Catch-22 situation and wish to genuinely help our unique patient population as best they can.  Apparently there will not be any formal directive or document issued but in my opinion of more benefit is that there is an offer by CMS staff to assist directly, patients like my spouse Joyce and others, on a case by case basis to obtain Medicare/Medicaid or private health insurance coverage for the care or replacement or explanting of the prosthesis for those patients implanted on or before May 4, 2007.

I have been allowed to share the individual’s name and contact information at CMS:

Ms. Amy Larrick | Senior Advisor to the Principal Deputy Administrator | Centers for Medicare & Medicaid

202-690-5742 D.C.

410-786-2585 Balt.

amy.larrick@cms.hhs.gov

Any implanted depression patient needing assistance must be prepared to supply the following information when contacting Ms. Amy Larrick:

One’s Name

Medicare number (from one’s Medicare Card)

Email address

Telephone number

I thanked her as I knew she personally was working on expediting Joyce’s needs through the bureaucratic system.  At the same time I told her there were several others who were in dire straits and needed immediate assistance.  Amy personally told me upon completion of our conversation she would also immediately contact several of the individuals who shared publicly with us all their serious circumstances.  I must state that I did contact these individuals to see if in fact they were contacted.  I wish to report that both Ms. Larrick and Mr. Blum have lived up to their words and commitments for which I am truly grateful.

To the physicians whom I blind copy in my many messages I would encourage y’all to pass along this information to the patients you attend to and to please spread the word.

I have some other thoughts which I wish to share Jonathan and Amy but for now the computer has gotten me this far and I did want to share what I consider “Good News”.

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://vnstherapy.wordpress.com/

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Monday, September 16, 2013

Favorable decision and document is forthcoming...

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, September 16, 2013 1:00 PM


Subject: Favorable decision and document is forthcoming...

To all of Joyce’s fellow implant patients,

Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services is understanding and compassionate to our circumstances and cause.

While our conversation was on the record I was requested to not record the conversation.  As I have been respectful of all the conversations I have had through the years both on and off the record and where I’ve been allowed to share or not share I shall honor Jonathan’s request.

I shall paraphrase what I took from the conversation.

There will be a document of sorts issued, hopefully by the end of the week, encompassing Medicare/Medicaid coverage for the implanted VNS Therapy depression patients on/or before May 7, 2007.  This document will also be sent to the private Medicare/Medicaid carriers encouraging them to follow suit.

I did request a contact within government for those encountering any difficulty navigating the maize to accomplish our goals.  I’ll have to wait and see as there are some internal mechanics within the agency that is still being worked on.

In my opinion, I did receive a very favorable response from Jonathan for which I truly thank him not only on behalf of Joyce but all of her fellow patients in desperate need of help at this time.

I truly hope I’ve brought some hope to you all.  By nature and having the experiences and knowledge I’ve garnered all these years I do bring you this hope.  At the same time and not to discourage anyone I am also reminded of baseball’s poet laureate Yogi Berra when he said, “It ain’t over ’til it’s over.”  Or in my words, “it’s not done until it’s done” (i.e. Cyberonics reneging on their “Lifetime Reimbursement Guarantee”) I hope to see an important piece of paper in your hands shortly to help advocate for yourselves, if necessary, to obtain your replacements as soon as possible.

Once again Jonathan, I truly appreciate your understanding and compassionate efforts for this group of patients.

I would also like to acknowledge and thank all those medical professionals and others, unseen in my blind copies, who have supported, educated and encouraged my advocacy and crusade.  Thank you Vivian and Congresswoman Debbie Wasserman Schultz.

I now have to get Joyce spoofed, nails, hair etc. and I’ve got to pack.  We shall be in New York for our eldest granddaughters Bat Mitzvah and I’ll formally be back at the computer late Tuesday evening, September 24, 2013.  My phone is on 24/7 for anyone needing support.

I wish you all L’Shanah Tovah (A Good Year - Hebrew) wellness and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://vnstherapy.wordpress.com/

Sunday, September 15, 2013

They all desperately want the same wellness now!

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, September 15, 2013 11:16 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius – HHS


Subject: They all desperately want the same wellness now!

Dear Jonathan,

It is roughly 24 hours from our scheduled 2nd conference call.  I have copied and pasted below another communication I just received.

Like Julie, Amy, Joyce and others I too am filled with major anxiety and stress.

I cannot accept anything less from you or Madam Secretary Sebelius than a favorable decision for “Compassionate use” for all these implanted patients prior to your department’s former decision of May 7, 2007.  Anything less would be immoral, unconscionable, inhumane and reeking of total outright negligence.  This issue not only directly affects the patient but so too their families and friends.

I expect you to tell me that a “Decision Memo for VAGUS NERVE STIMULATION for Treatment of Resistant Depression (TRD)” is being issued immediately and in the “Decision Summary” it will state something to the effect that:

CMS has determined through it’s initial oversight that there is sufficient evidence to conclude that vagus nerve stimulation is reasonable and necessary for treatment of resistant depression for all those implanted patients wishing to continue the therapy who have been implanted on/or before May 7, 2007. Accordingly, we are issuing the following national coverage determination and/or “Compassionate use” determination:

Vagus nerve stimulation is covered for treatment resistant depression for all implanted patients having been initially implanted on/or before May 7, 2007.

Nothing less than some document of this nature can be humanely acceptable. 

Julie, Amy and Joyce, amongst others have now known and tasted wellness for years.  They all desperately want to retain that same wellness; now!

To Julie, please understand that Joyce’s neurosurgeon fully understands the nature of this whole situation.  He too is blind copied and receives the same communications from me.  While we do have a scheduled surgery date we have not yet heard anything from our insurance carrier or the hospital whether or not she will be accepted/rejected.  In essence I am pushing the issue for Joyce and all the other implanted patients who wish to continue the therapy.  Mr. Jonathan Blum’s signature or that of Madam Secretary Kathleen Sebelius would simply and quickly resolve our issue.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trail more Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

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Julie Ottaviani

10:11 AM (September 15, 2013)

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to me

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Dear Herb,
I write to you again with my thoughts because I have not slept at all this weekend waiting for the phone call from Jonathan Blum to yourself on Monday Sept. 16th 2013.  I feel that my very life is hanging by a thread at this time.  Unlike yourself and Joyce my doctor or myself cannot even get a surgeon or hospital to schedule my surgery.  I am desperate and sinking fast.  When I think back to the day my implant was originally put in at Moses Taylor Hospital in Scranton Pa, by Dr. Michael Sunday, I become angry and sad.  Both the hospital and Dr. Sunday knew at the time there was no decision on payment and that I would try and help get payment if need be.  Before they wheeled me in for surgery I took Dr. Sunday's hand and thanked him for giving me another chance at life by doing the surgery.  Now that I need a replacement and Medicare has decided the Implant is not covered.  Dr. Sunday flat out refused to see me for the replacement and so did Moses Taylor Hospital.  The people that I thought cared about my life only cared about profit.  If they really cared they would have me on a table right now doing the surgery without a decision.  That is why Jonathan Blum's call is so important, because there is less compassion for mental health patients than any other patient.  If I had cancer would I be denied chemo, If I had diabetes would I be denied insulin, they'll even pay for a heart transplant but not a tiny little metal round disc in my chest that cost's quarter not even what a transplant costs to make me tax paying member of society again.  Pass compassionate use.  PLEASE
Julie Ottaviani
11 Alexandria Drive
Blakely, Pa 18447
570-604-3043
You have my permission to use this email and all it's contents in any way you choose if it will help our cause.

Julie Ottaviani
julieottaviani@aim.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Friday, September 13, 2013

Oh Herb do I dare have hope?


From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 1:48 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: Oh Herb do I dare have hope?

 

Julie Ottaviani
10:49 PM (September 12, 2013)
https://mail.google.com/mail/u/0/images/cleardot.gif
https://mail.google.com/mail/u/0/images/cleardot.gif
https://mail.google.com/mail/u/0/images/cleardot.gif
to me
https://mail.google.com/mail/u/0/images/cleardot.gif

Oh Herb do I dare have hope?  I listened to your conversation with Jonathan and all I heard was the same old nonsense. I'll get back to you. I received my denial letter from my insurance company Humana Advantage stating the CMS policy on coverage of patients implanted after May 2007 which doesn't apply to me, I was implanted Jan. 12, 2006. And they also said I was denied because it was being used to diagnose which again does not apply to me because I am already implanted with 100% success for the last 7 years.  When I called and questioned them they had no answer for me except that my doctor would have to call in and make a verbal appeal for medical necessity.  I explained that they should be talking to me because my doctor was dead and the doctor making the request did not treat my illness for the past 15 years.  Fell on deaf ears.  The psychiatrist who is the partner of my doctor that passed away is Dr. Mathew Berger and quit frankly knows nothing about me. Just to fill you in Joyce's history is severe and no one should suffer with this black cloud my suicide attempts totaled 12 and a few times my oldest son who was about 12 at the time was the person calling 911.  Do you know that to this day even though I would not attempt suicide again because after being well for so long I realize the pain that it caused my family and my children, I still instinctively keep a full bottle of klonapin just in case I don't get the battery.  I swore I would never go back into the black hole of depression I would rather be dead.   I mentioned my decline to Dr. Berger at my appointment on Sept. 12th and also about my conversation with you and your working with other doctor to convince CMS to pass the compassionate care issue.  He did not seem to know anything about it.  I feel more alone than ever.  I mentioned to you in our conversation that I was going to consult my lawyer about the very issues you brought up in your telephone conversation with Blum and he told me it was pointless to file a suit against CMS it's like banging your head against a brick wall.  As I was listening to you tell Joyce's story it was all so familiar to me, the endless medications

the ECT treatments that did more harm than good, but medicare will pay for them.  It is because of too much shock therapy that I am on disability and costing the system money although a  lot less since the VNS was put in.  ECT wiped out most of my long term memory and damaged my short term memory.  So much gone my whole lifetime.  My talent and what earned me a living.  I was somewhat of a child prodigy on the guitar classical.  By the age of 12 my teachers told my parents they couldn't teach me any more that I had learned everything they knew and more.  So I began teaching.  I planned on music being my life's work.  After the treatments I could not remember how to read a note.  It was gone all gone.  All I could remember were a few basic chords.  I have never picked it up since that day.   Hospital bills eventually ran us into bankruptcy.  And when I finally got the implant in 2006 my improvement was just as quick as Joyce's and very similar. I did get a little manic for a while but not bad it was a kind over happy manic and my very much missed Dr deSoto put it " Your way too happy girl, we have to turn you down a notch".  Loved that man.  So I'm going to be waiting to hear from you on Monday after you speak to Blum and I will be praying for a positive answer for Joyce, myself and all of us fighting this battle.  Thank you for being our knight in shining armor.

Julie Ottaviani
11 Alexandria Drive   
Blakely, Pa  18447       
570-604-3043

You have my permission to use any or all of this email in anyway you think will be useful in our fight.
Julie Ottaviani

 

 

 

Dear Jonathan,

 

What does it take to get through to all you folks that your department’s negligence and further delays are seriously harming the very folks that you should be caring for and that the multi-year wellness they’ve derived from VNS Therapy are also reducing health care costs.

 

After speaking with Dr. Daniel Schultz earlier in the day I’ve come to the conclusion it may well be both your “medical team” and his former so called “experts” appear to be out of touch with reality.

 

Today I was also reminded of my immediate thoughts and response after reading the contents of the May 4, 2007 national coverage denial document.  I certainly was not happy to read the final determination.  But what truly appalled me was some of the contents of which I read.  Whoever composed the document, in my opinion, denigrated the physicians who practice psychiatry and the Art and Science of Psychiatry.  If I were a Psychiatrist, I certainly would be appalled.  There is no doubt in my mind that the authors of that document have no understanding of the difficult challenges these physicians face day in and day tending to this unique and seriously ill population of patients with whom conventional therapies are ineffective and very costly.  How can these people who penned that document really have an understanding when amongst other statements they issue the below listed statement?

 

D02 RCT

The well-designed, randomized controlled trial (D02) of 10 weeks (standard trial length for efficacy determination of an antidepressant medication)

failed to demonstrate statistically significantly superior outcomes greater than sham treatment (15% versus 10%, p = 0.31 (Fisher’s exact)).

 

“The well-designed, randomized controlled trial (D02) of 10 weeks…” sums up what little they knew and understood and what appears to continue to this very moment.  Dr. Schultz in my conversation with him today cited that a study of such a short duration was a mistake from the start and doomed to failure.  Amongst this and other points he, unlike his underlings, saw beyond their computer screens and as a practicing physicians he understood the need for the therapy.  The study needed more time but why discuss this matter now as any reasonable minded individual knows it was a mistake.  These patients for whom I advocate have not only responded but obtained long-term efficacy as you’ve read.  Yet your department issued the absurd statement amongst other abominating statements. 

 

The point being that it seems to me y’all still can’t comprehend what is being exhibited before your very eyes.  Once again, 100% of these implanted patients wanting to continue this therapy are responders obtaining long-term efficacy.  What can’t your “medical team” or any of you folks not comprehend or compute?

 

Your department issued the non-coverage statement on May 4, 2007.  Now do the morally right and just thing and issue a favorable “Compassionate use” decision for all those patients implanted on or before May 4, 2007.  At the same time it should put a smile on Dan Moore’s face as it will relieve Cyberonics of any responsibility or legal worry of violating “kickback statues” (joke).

 

Sincerely,

Herb

 

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




 

 

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

 

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

"I write this I am preparing for another hospitalization."

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 9:43 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: "I write this I am preparing for another hospitalization."

Dear Jonathan,

I have copied and pasted another email below that I just received.  It too is self-explanatory.

I shall not give up.  I owe it to my spouse Joyce and Amy, Julie, Tami and all the other patients wanting a chance to live out their lives in peace, wellness and with dignity.

We need your help now…no more kicking the can down the road.  We need another individual with the compassion and understanding as exhibited by Dr. Daniel Schultz to do the right thing.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trail more Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

/////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

Tami

8:29 PM (September 13, 2013)

clip_image001

 

clip_image001[1]

clip_image001[2]

to me

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Herb,

I listened to your phone call with Jonathan Blum of CMS.  Me and my family are waiting on pins and needles to find out if the "Compassionate Use" document will be signed .  It is all I can do to follow your blog, but it has given me a glimmer of hope.   As I write this I am preparing for another hospitalization.  It will not help me other than to keep me safe for a few weeks.  Mr. Blum and the other "powers that be" need to understand the cost to so called treat my depression will continue to increase until it is greater than the cost of VNS.  I had not been hospitalized or had ECT for the five years my VNS worked.  

My battery died two years ago.  Since then I have been hospitalized once and am home bound and practically bed bound.   My very life depends on getting my VNS replaced soon.  VNS saved my life!  I just wish Mr. Blum and the others would see that I am a human being and I am pleading and begging for my life.  

Bless you for your advocacy.   As always, you have my permission to publish or use this email in anyway that will help.

Tami Gee

8913 Fresno St

Fort Smith, AR

firetlg@aol.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

"...treating severe unresponsive depressive disorder is exactly the reason that I approved the device..."

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 2:37 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: "...treating severe unresponsive depressive disorder is exactly the reason that I approved the device..."

Dear Jonathan,

I just received an email which I have copied and pasted below from Dr. Daniel Schultz (please read from the bottom of this page on up) as it is self-explanatory.  It also satisfied my 9 year need to know and understand this courageous and compassionate man’s thinking despite all the controversy surrounding this therapy option.

While Dr. Schultz also had medical experience and wisdom to understand the nature of the illness and challenges, you and Madam Secretary Sebelius certainly have far more information available at this time than Dr. Schultz.   At the very minimum you both by now should understand health benefits being obtained by these existing implanted patients.  This is no longer experimental for these patients.  This therapy has demonstrated for these patients 100% efficacy which cannot be denied nor in the annuals of psychiatric treatments has there been an efficacy demonstrated anywhere near to what I am presenting to you for these patients.

Again, correct the negligence perpetrated against these study subjects and patients.  Do what is morally right.  Issue a favorable “Compassionate use” decision now so that Joyce, Amy and the other patients can return to a reasonable quality of life.  The byproduct of their wellness is a cost savings to our economy.  Take care of the problem now or continue to pay higher and higher ineffective maintenance costs year after year.

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

http://vnstherapy.wordpress.com/

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 13, 2013 2:05 PM
To: 'Daniel Schultz'
Subject: RE: VNS Therapy for depression...

Dear Dan,

Thank you ever so much for taking the time to talk with me the other day and for sharing your thoughts in this email.

I am making every effort humanly possible to get the powers that be to understand and issue a favorable “Compassionate use” decision for all those implanted patients prior to the national denial.  While I do believe like you that it is important to have newer treatment options available for these difficult to treat patients my immediate and urgent goal is care for those who have for multiple years responded and obtained efficacy.

L’Shanah Tovah as I also wish you and yours wellness and all the good you’d wish for yourselves.

Once again, thank you.

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

http://vnstherapy.wordpress.com/

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

From: Daniel Schultz [mailto:daniel.schultz@greenleafhealthllc.com]
Sent: Friday, September 13, 2013 1:55 PM
To: Joyce and Herbert Stein
Subject: Re: VNS Therapy for depression...

Hi Herb,

It was very nice talking to you yesterday and hearing how well your wife Joyce is doing with her VNS therapy. Providing patients with like Joyce with another option for treating severe unresponsive depressive disorder is exactly the reason that I approved the device and your story and others like it confirm my belief that despite the controversy associated with that decision, it was the right thing to do. 

I hope that Joyce and other patients who have benefited will continue to have access to the therapy and whatever reimbursement issues exist can be resolved to everyone's satisfaction.

Best regards,

Dan   

Daniel Schultz, M.D.

Senior Vice President, Medical Devices & Combination Products

Greenleaf Health LLC

202-609-8996 x2 w

240-401-2382 m

www.greenleafhealthllc.com

Greenleaf Health's NEW main number is 202.609.8996

Thursday, September 12, 2013

I’ve finally made contact with Dr. Daniel Schultz…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 12, 2013 2:55 PM
Subject: VNS Therapy for depression...

To all of Joyce’s fellow implant patients,

This morning after some searching I was finally able to make contact with Dr. Daniel Schultz.  For many of you his name may not be familiar but from my vantage point as a long, long time support person and health care advocate for Joyce and my knowledge of VNS Therapy for depression his decision for us was monumental.  Dr. Schultz was the former Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004 to 2009.  It was Dr. Schultz’s compassionate, caring, medical knowledge and understanding as a practicing physician whose decision on July 15, 2005 (document attached) has brought us to this point in time. 

I also share with you a link so that many of you would have a better understanding of the challenges and thought climate at that time.

I spoke with Dr. Schultz by telephone this morning.  His reply to my questions has finally satisfied my long-time desire to understand one man’s thinking.  I share the below listed email with you.  I’ve asked Dr. Schultz’s aid to please share with me, on-the-record, so that all of you will also understand his thinking on the subject of VNS Therapy for depression.  I do so in the further hope that we may obtain a favorable “Compassionate use” response from Mr. Jonathan Blum – CMS or Madam Secretary Kathleen Sebelius – HHS so that they too may understand our desperate and immediate need for health care coverage.

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

http://vnstherapy.wordpress.com/

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, September 12, 2013 12:01 PM
To: Dr. Daniel G. Schultz
Subject: VNS Therapy for depression...

Dear Dr. Schultz,

About 9 years ago I wrote to you thanking you for what I considered a very courageous decision in spite of all the circumstances and turmoil surrounding the VNS indication for depression.  I will also add despite the subsequent inept investigation by Senator Grassley’s people, in my opinion.

I thought your decision courageous because of the enormous pressures being exerted but I can tell you from my knowledge then and that which I better know today, it was a correct and humanist decision for a number of patients who were considered the “worst of the worst” which included my spouse Joyce.

My spouse Joyce was one of the earliest study subjects.  She was implanted December 13, 1999.  This December 2013 will be her 14th anniversary of the therapy.  She has been almost continuously depression free these 14 years.  She is on no antidepressant medications and we haven’t discussed the illness of depression in our home for years.  As far as CMS is concerned there is no doubt in my mind we’ve also saved them untold costs.  We no longer have yearly multiple hospitalizations consisting of 2 to 3 week stays.  No ECT.  Joyce is off all antidepressant medications, no longer do we have weekly visits for psychotherapy and medication checks as she now sees her psychiatrist quarterly to interrogate her prosthesis and the quality of life for both of us improved 180 degrees.

So, exactly what prompts me to contact you after all these years.  First, anything I do discuss with you is off-the-record and confidential other than what you would allow me to share publicly.

I am in a major battle with Madam Secretary Kathleen Sebelius – HHS and Mr. Jonathan Blum – CMS pleading with either of these 2 bureaucrats to sign a favorable “Compassionate use” document for all the VNS depression patients implanted on or before CMS National decision on May 4, 2007.  As I’m sure you are aware and to the best of my knowledge, this was the first time an FDA device was declined coverage by CMS.  In doing so, they have caused an egregious injustice, morally, ethically and through their negligence to have not at least grandfathered the care for the study subjects and the other implanted patients who obtained the therapy through Medicare/Medicaid, private health insurance and other means before the national coverage decision.

I am doing everything in my power to humanize this issue as I strongly sense these department heads and their underlings are number pushers and lack any true understanding or hands on medical experiences about these real life struggles.  I’ve even attempted sharing my yearly VNS video of Joyce to further humanize her and the issue.

At the same time I am battling Cyberonics to honor their “Lifetime Reimbursement Guarantee” to the study subjects.  Cyberonics has reneged on the guarantee as Dan Moore, CEO of Cyberonics throws smoke screens at the subject citing “kickback statues” to which I politely replied in my own mind, “He’s full of shit,” but in actual writing this was my response to Dan.

I maintain and advocacy blog site at: http://www.vnstherapy-herb.blogspot.com which should give you a good feel about the previous correspondence and my advocacy.  I do converse and collaborate with a number of the leading psychiatric KOL’s both on and off the record.

Second and most importantly I am asking for your help.  After all these years I am asking you once again, what is it that you saw, understood, knew or believed to prompt you to override the so called knowledgeable opinions of your “expert” subordinates to approve VNS for the depression indication?   

If you choose to answer that question or lend any kind of assistance to our cause would you please advise me what part or parts of your response might I be allowed to share publicly or if not at all?

My wife and the other VNS patients are truly desperate.  They do not want to return to the hell they once endured and most patients cannot afford to pay out-of-pocket for the replacement surgery.

Please consider helping us.  I am at this advocacy 24/7/365 until we achieve our goal of health insurance coverage.  I would welcome your response in any manner day or night.

Jonathan Blum – CMS has scheduled with me a second telephone conference this Monday, September 16, 2013, 12:00pm as they continue to kick the can further down the road.  My first conference call can be heard at this link:  http://www.vnstherapy-herb.blogspot.com/2013/09/vns-therapyconversation-with-mr.html

I truly do not have the slightest idea of the internal workings and mechanics of these various governmental departments.  I ran, at the time before my retirement, a successful small multi-million dollar company and I knew when there were decisions to be made I sat down with my partners, we reviewed the facts, discussed the issues and made a decision.  Hopefully the correct decision most of the time but all done within an hour or two at the most.  From my vantage point and of now having to deal with government agencies it is incredulous to me to see how in the world our government gets anything effectively accomplished if at all.

I seek your aid, knowledge and understanding to better help advocate our cause during this second conference call if you would take a few moments to lend us a hand.

I would also like to wish you and yours L’Shanah Tovah, wellness and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

vnsdepression@gmail.com

http://vnstherapy.wordpress.com/

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Wednesday, September 11, 2013

VNS Therapy – Conversation with Mr. Jonathan Blum – CMS

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, September 11, 2013 2:41 PM
Subject: VNS Therapy "Compassionate use" for depression patients...

To all of Joyce’s fellow implant depression patients,

In trying to keep you all informed to the best of my ability and to which I am allowed to publicly share information as it relates to my efforts to obtain a favorable “Compassionate use” determination for all the patients implanted for depression on/or before May 4, 2007 I would like to share some information.  While I have not yet achieved my goal you should know the following as I continue advocating for you all.

I would first and most importantly like to thank Mr. Jonathan Blum - CMS for taking his valuable time to speak with me personally to better understand Joyce’s and your very serious medical issues requiring immediate attention.  Quite frankly, I expected to be listening to Jonathan but he threw me a curve ball and I awkwardly did most of the speaking.  By the way, please also forgive my southern drawl if y’all don’t understand my speech.  I grew up in the deep South; that is South Brooklyn (joke).

My telephone conversation with Mr. Jonathan Blum – CMS

Joyce and I shall be leaving on Tuesday, September 17th to New York to attend our eldest granddaughter’s Bat Mitzvah.  We shall return on Tuesday, September 24th so I’ll be less available by computer for the week but my phone is on 24/7 if you folks need support.

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://vnstherapy.wordpress.com/

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Monday, September 9, 2013

Time is running out for these patients…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, September 10, 2013 12:26 AM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius - HHS
Subject: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...

Dear Mr. Blum,

I had some computer problems and was just able to retrieve my emails from yesterday. 

I have copied and pasted below another email that I just read.  I several minutes ago got off the telephone with the young woman who sent the email giving me verbal permission to share her correspondence publicly.

Need I say more to you or Madam Secretary Sebelius.  Joyce, this young woman Amy and the other patients are running out time.  They do not want to return to a living hell.

We are all pleading for a favorable “Compassionate use” decision from you or the Madam Secretary, now!

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

http://vnstherapy.wordpress.com/

From: Amy [mailto:keyanote@gmail.com]
Sent: Monday, September 09, 2013 3:00 AM
To: Joyce and Herbert Stein
Subject: Re: A continuing please for a favorable "Compassionate use" decision for the already implanted VNS depression patients...

Herb,

I really hope you receive an answer soon. Things are getting worse here...I started a new drug called Latuda and increased the Lamictal but I am feeling so bad tonight.  I'm am crying uncontrollably and feeling hopeless.  Life is getting back to what my "normal" used to be back before I had the VNS.   If they want a real live experiment of what happens when the battery dies...here I am.  Thank you for all your work and letters. 

~ Amy

Friday, September 6, 2013

The pleas for help are slowly trickling in…

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 06, 2013 3:50 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius – HHS

Subject: How many appeals and pleadings will it take to make you folks see the light?

Dear Mr. Blum and Madam Secretary Sebelius,

I’ve moments ago received another very compelling email correspondence from another VNS depression patient which I’ve copied and pasted below.  These real-life experiences are slowly trickling into me.  I have asked those patients, allowing me to share their personal life experiences, to also list their full names, addresses, telephone numbers etc. so that your “Medical team” can validate this data should they have nothing else better to do.  In doing so I am once again supplying facts/data that I would believe do not register in your computers or records of any kind.  I also ask these patients to share this information in the hope that maybe you or your people can comprehend the devastating effect your continued negligence and immoral position is having upon these patients.

How long will it take for you and your staff and Madam Secretary Sebelius and her staff to correct the wrong you’ve perpetrated and the negligence you’ve created by not caring for these patients?

Either of you two department heads have the ability through the stoke of your pens to cease this ongoing agony, suffering and forcing these patient back into hell.

I would only hope that some attorney with compassion and understanding for helping others might come across our pleas and find a legal issue to address your outright negligence, in my opinion.  I’ll have to look up the name of the attorney and the judge that ruled in the case for that 11-year old youngster in obtaining adult lungs for the young girl.  Maybe then we can get you folks moving in a favorable direction.

I hope you all have a wonderful weekend filled with the thoughts and remembrances of what you are reading from these real-live citizens whose anguish you can easily and morally end.

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://vnstherapy.wordpress.com/

From: ssagi@aol.com [mailto:ssagi@aol.com]
Sent: Friday, September 06, 2013 3:00 PM
To: fabrik@bellsouth.net
Subject: My VNS Story

My name is Sharon Strugnell and I am 66 years old.  I have suffered with depression since I was 16 years old when I had my first episode.  It is a horrible out of body experience, the worst ever.  You do not even feel human.  All you want to do is die and disappear.  I had a wonderful caring psychiatrist who was the most positive person in my life.  I believe he was at the end of his rope trying to help me but he never gave up and he found an article in some paperwork he received that advertised for people to volunteer to be study subjects for VNS.  He immediately called me and of course I said yes.  He set me up and filed all the paperwork with Cyberonics for me to participate in their research for their Vegas Nerve Stimulator.  He worked so fast that I was number one study subject.  I, too, tried every antidepressant made to man, psychiatrist after psychiatrist, 15 shock treatments, hospitalized for four weeks and nothing came close to helping at all. This illness effects everyone of your friends and family.  Somehow I came out with two beautiful daughters and five grandchildren. My husband stuck by my side though it all and was with me throughout the ordeal. Most of the time people want to run away from people like me as we cannot do anything but bring people down.  What kind of a life is that?

My stimulator was implanted on August 14, 2006.  It took a while to work but what wonderful results happened.  I am a new person now and honestly would love to help other people with this problem.  You cannot fully understand what it is like until you experience it and believe me, you wouldn't want to. I did my clinical study at FAU in Florida.  I never missed an appointment for five years as we sign that we will follow through with this program so with the hope that it would help other people as well. My doctor that headed the program was Dr.Peter Holland, a wonderful man.  My battery life had the expectancy of 5 years and I have been so lucky that it is still functioning, but I live in fear of the day the battery dies. I do not think I could ever go through that torture of the Black Hole again. It is truly a killer.

I am pleading with you to help myself and all other VNS receipients that want to continue their therapy.  It is such a shame that people have to commit suicide because they have nothing left to try.  What if it was your mother, father, husband or child that suffered so?  What would you do?  I never thought that I would have to plead for my life when I signed up for this study.  I thought all my problems were over.  So did everyone else I am sure. We appreciate everything Herb is trying to do to help us and his wife.  Thank you for reading this and for your time.

Sincerely

Sharon Strugnell

1365 SW 151st Way

Sunrise, FL 33326-1932

e-mail ssagi@aol.com

Phone:  954-801-9468

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