"Does anyone in all of HHS/CMS understand the meaning of being "proactive"?"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, August 10, 2015 2:40 PM
To: Stephanie Perry, Health Insurance Special - Office of the Medicare Ombudsman - CMS
Cc: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: "Does anyone in all of HHS/CMS understand the meaning of being "proactive"?"

Dear Ms. Perry,

First I’d like to thank you for taking my telephone call the other week and for your recent letter (attached).  I’d also like to apologize for my previous misspellings of your name as apparently I did not hear it clearly in our conversation.

In your letter you stated:

If you would like to request a NCD for VNS for those persons, prior to May 4, 2007, who

Obtained Medicare coverage for VNS to treat resistant depression and who continue to

Receive that treatment, please visit:

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/howtorequestanNCD.ht

ml.  This will provide you information and instructions on that process.

Once again I wish to reiterate that when I proactively embarked some two (2) years ago on my advocacy/activism to correct the egregious and morally wrong ineptitude perpetrated against these VNS depression patients by the oversight for medical care in the May 7, 2007 decision I started out by requesting “Compassionate Use” from the former and present Secretary of Health and Human Services for these patients.  As time progressed and no such document was forthcoming I learned of other decisions rendered by the judicial entity of CMS.

[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]

[Proposed Rules]

[Pages 40835-40890]

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

[FR Doc No: 2013-16107]

U.S. Administrative Law Judge sides with VNS Depression Patient

Department of Health and Human Services

DEPARTMENTAL  APPEALS BOARD

Appellate Division

NCD 160.18, Vagus Nerve Stimulation 

Docket No. A-14-3

Decision No.  2613

December  30, 2014

The essence of these documents is the doctrine of “Continuity of Care” and more specifically as it relates to VNS depression patients implanted prior to May 4, 2007.  Therefore that decision does not apply to these VNS patients for whom I advocate.  Is that too difficult for all to comprehend. 

The point of all my communications is the obvious lack of “proactive” actions on the part of HHS/CMS with the exception of Jonathan Blum, Amy Larrick and Courtney Turner.  The fact is no one discusses any of the decisions listed above and no one has indicated to me in all the communications I’ve had, including yours, that these decisions have been sent to MAC, Regional Offices, State Agencies and/or Contractors etc. to read, understand and acknowledge.  If so, this would eliminate the need for any denial or question in MAC’s and/or other agencies decision making process and eliminates the need for the patient to appeal a MAC and/or other agency denial.  Yes, I understand your letter all too clearly only you too continue the negativism, roadblocks and need to challenge these patients instead of really helping them.

Apparently what many of you folks cannot fathom or understand is the fact these patients are often physically and mentally unable to care for themselves let alone advocate for themselves especially when in the throw of severe depression.  All do not have “Herb” to battle the bureaucracy’s constant Tower of Babel or what I also refer to as “Bureaucratic Speak”.

Does anyone in all of HHS/CMS understand the meaning of being “proactive”?  The information to help these patients is on record.  It is not there to challenge them or be omitted from all communications.  So how about someone in authority finally getting back to me after all this time telling me that all the decision makers within your voluminous bureaucracy acknowledges the additional information pertaining to these VNS depression patients instead of rehashing that same old egregious May 4, 2007 document which does not apply to this patient group?

I’ll also take the liberty to remind you and your colleagues once again the meaning of being proactive from your own agencies mantras “especially for those who are least able to help themselves”:

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

 

Stolen equipment and the expeditious resolution…

To Joyce’s fellow VNS patients et al,

Just recently we ran into an unusual problem(s). We made an appointment with Joyce’s attending physician to interrogate her VNS prosthesis. The appointment was made for Monday, June 22, 2015. As we were about to leave our home for our scheduled appointment we received a call cancelling the appointment as the doctor could not find his handheld computer to interrogate the device.

We rescheduled the appointment for the following Monday, June 29, 2015 and I advised his office I would send a reminder to the doctor on Sunday prior to our office visit to bring the equipment. I e-mailed the doctor as a reminder early Sunday and later that evening I received a return correspondence that the interrogating equipment had apparently been stolen from his office. Late that same evening I sent an e-mail to Dan Moore, CEO – Cyberonics and his associates asking for help. Much to my surprise even later that Sunday evening I received a reply.

I have been allowed to share the correspondence and events that have unfolded and acknowledge the coordinated efforts of the Cyberonics staff. . I wish to extend my appreciation and gratitude publicly for the expeditious handling and resolution of the problem(s) and help I received. I rightly feel it proper to exhibit all sides of the coin unbiasedly as possible in view of the fact that I have at times respectfully expressed harsh critical opinions of the company as it related to several other issues.

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 11:25 AM
To: Dr. Ely Pelta
Subject: Reminder...

Hi Doc,

Just a friendly reminder to please bring the wand with you to interrogate Joyce’s prosthesis tomorrow!

I hope all is well with you and yours.

Herb

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

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: Ely Pelta [Redacted]
Sent: Sunday, June 28, 2015 1:50 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb. The wand went missing, can you provide me with a contact to get a replacement wand?   It most likely was stolen.  I looked everywhere
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 6:14 PM
To: 'Ely Pelta'
Subject: RE: Reminder...

Doc,

Is the wand all that is missing or are you missing the handheld computer too?

Please let me know promptly and I’ll try to contact Dan Moore, CEO of Cyberonics to help us out.  I’ll cancel our appointment for tomorrow until you’re once again equipped.

Thanks,

Herb

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

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: Att [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 8:53 PM
To: Herbert Stein
Subject: Re: Reminder...

Herb, missing it all , thanks for understanding
Sent from my iPad

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 9:38 PM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Jackie J. Baumgartner; Dr. Mark Bunker; Bryan Olin, Ph.d
Subject: Stolen equipment...

Dear Dan,

I hope this note finds you and yours all doing well.

I need your assistance.  Apparently someone has stolen Dr. Ely Pelta’s handheld computer and wand and I shall have to cancel Joyce’s appointment for tomorrow to have her prosthesis interrogated.

I would sincerely appreciate if you could have one of your staff immediately contact Dr. Pelta to arrange for a replacement of the equipment.

Dr. Ely Pelta

Miami Beach Community Health Center

11645 Biscayne Boulevard

Miami Beach, FL 33141

305-538-8835 x1670 for Dr. Pelta

(Redacted)

Bianca F., nurse for Dr. Pelta

Carla is Dr. Pelta’s secretary at 305-538-8835 ext. 1670

As always, I thank you for your prompt attention to my concerns as I wish you all well.

Dr. Pelta,

Please have your office notify me promptly once you’ve obtained the replacement equipment so that we may reschedule Joyce’s appointment.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, June 28, 2015 10:40 PM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Jackie J Baumgartner; Mark Bunker
Subject: Re: Stolen equipment...

Dear Herb,
I will work with our team in the South Florida area and the doctor to see what we can do. I don't know if we can get something by the appointment tomorrow, but we'll do our best.
Best regards,
Bryan
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, June 28, 2015 10:59 PM
To: 'Bryan Olin'
Cc: 'Dan Moore'; 'Dr. Ely Pelta'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Dear Bryan,

Thank you for your very speedy reply.  It is most appreciated.

We’ll at worst have to reschedule for next week but it is your cooperation and that of your company’s personnel that is most impressive and outstanding to me.

I may have some respectful differences on certain issues with you folks but I cannot deny the fact they y’all have gone to bat through the years to help me care for Joyce for which I truly thank you.

Once again, thanks Bryan.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Ely Pelta [mailto:(Redacted)]
Sent: Sunday, June 28, 2015 11:16 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

Great job Herb !
Sent from my iPhone

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

From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:06 AM
To: fabrik@bellsouth.net
Cc: (Redacted)

Subject: RE: Stolen equipment...

Mr. Stein,

I am the Nurse Case Manager at Cyberonics who works with the Depression patients and their Psychiatrists.  I was asked to communicate with you about replacing Dr. Pelta’s programming equipment.  We will be overnighting the new equipment to Dr. Pelta’s office in Miami today and he should have it tomorrow morning.  I will reach out to both Carla and Bianca to let them know the replacement equipment has been ordered and to ecxpect arrival tomorrow morning.

If you need assistance with anything else, please let me know.

Take care,

Susan

Susan Dotson, L.V.N., Sr. Manager

Case Management Department

Manager for the Carolinas, Lone Star and Southeast Regions

Depression Case Manager

Toll Free:  1-800-332-1375, ext. 7363

Direct Number:  281-228-7363

Direct Fax:  281-853-1315

E-mail:  susan.dotson@cyberonics.com

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, June 29, 2015 10:44 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Jackie J. Baumgartner
Subject: RE: Stolen equipment...

Dear Susan,

Thank you for reaching out and quickly coming to our assistance.  By copy of this e-mail I am alerting Dr. Pelta to expect the replacement equipment tomorrow and to also alert his staff.

Your prompt help and that of your fellow staff members have proven invaluable to maintaining Joyce’s depression free-state these many years.

Once again, thank you.

Dr. Pelta,

Please have Bianca call me as soon as the replacement programming equipment is received so that we may promptly schedule a new appointment for Joyce.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Monday, June 29, 2015 10:47 AM
To: Herbert Stein
Cc: Dr. Ely Pelta; Dan Moore; Bryan Olin; Mark Bunker; Jackie J Baumgartner
Subject: RE: Stolen equipment...

Dear Mr. Stein,

You are welcome…always happy to assist.

Take care,

Susan

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

From: Ely Pelta [mailto:(Redacted)]
Sent: Monday, June 29, 2015 1:03 PM
To: Herbert Stein
Subject: Re: Stolen equipment...

I will be looking for it tomorrow
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 01, 2015 1:43 PM
To: Dr. Ely Pelta
Subject: Replacement equipment and rescheduling appointment...

Doc,

I haven’t heard from anyone in your office whether or not you received the replacement equipment so that we can reschedule an appointment for Joyce.

Please advise me.

Herb

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

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: Ely Pelta [mailto;(Redacted)]
Sent: Thursday, July 02, 2015 8:27 AM
To: Herbert Stein
Subject: Re: Stolen equipment...

Came today
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 8:46 AM
To: 'Ely Pelta'
Cc: Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Bryan Olin, Ph.d; Daniel Moore, CEO - Cyberonics; Jackie J. Baumgartner; Dr. Mark Bunker
Subject: RE: Stolen equipment...

Doc,

Thanks.  I’ll schedule a new appointment for Joyce.

Susan, Brian et al,

Thank you too for your prompt help and assistance.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 9:00 AM
To: Herbert Stein; 'Ely Pelta'
Cc: Bryan Olin; Dan Moore; Jackie J Baumgartner; Mark Bunker
Subject: RE: Stolen equipment...

Mr. Stein,

I am glad to hear that the equipment was delivered.  Please let me know if you need assistance again.

Take care and have a nice 4^th of July!

Susan

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, July 02, 2015 9:21 AM
To: 'Susan Dotson'; 'Ely Pelta'
Cc: 'Bryan Olin'; 'Dan Moore'; 'Jackie J Baumgartner'; 'Mark Bunker'
Subject: RE: Stolen equipment...

Susan,

Thanks again and you too have a happy and safe 4^th of July.  And if you don’t mind, family, friends and business associates all call me Herb.

Herb

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

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: Susan Dotson [mailto:Susan.Dotson@cyberonics.com]
Sent: Thursday, July 02, 2015 10:20 AM
To: Herbert Stein
Subject: RE: Stolen equipment...

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, July 15, 2015 8:53 AM
To: Dr. Ely Pelta
Subject: Reminder...

Doc,

Joyce has an appointment with you tomorrow.  Please remember to have the interrogation device available.

Thanks,

Herb

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

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: EDP [mailto:(Redacted)]
Sent: Wednesday, July 15, 2015 1:02 PM
To: Herbert Stein
Subject: Re: Reminder...

It's fired up and ready 

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 10:45 AM
To: Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker
Subject: VNS Technical Question

Dear Susan,

Once again I’d like to take this opportunity to thank all you guys for speedily coming to our assistance.

Yesterday we finally got to see Dr. Pelta who interrogated Joyce’s prosthesis (Model 104).  All settings for Joyce were normal with one exception as Joyce continues with her depression free state.  Dr. Pelta’s newest handheld computer did not indicate the battery life as we previously were able to view (Please see photo below).  Is there something wrong with the programming or hardware of the handheld device or whatever?

Would you please advise a solution to this problem?

Thank you as always.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Friday, July 17, 2015 10:51 AM
To: Herbert Stein
Cc: Susan Dotson; Dr. Ely Pelta; Dan Moore; Mark Bunker
Subject: Re: VNS Technical Question

Dear Herb,
I contacted our Clinical Technical Support team and asked them to contact you and Dr. Pelta to answer your question.
Best regards,
Bryan
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 17, 2015 11:02 AM
To: 'Bryan Olin'
Cc: 'Susan Dotson'; 'Dr. Ely Pelta'; 'Dan Moore'; 'Mark Bunker'
Subject: RE: VNS Technical Question

Brian,

As always your exceptionally prompt responses I greatly appreciate.

Have a wonderful weekend.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Dylan Adams [mailto:Dylan.Adams@cyberonics.com]
Sent: Friday, July 17, 2015 3:47 PM
To: fabrik@bellsouth.net
Subject: Joyce's VNS Device

Hi Herb,

Thank you again for talking with me today. While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.

Best regards,

Dylan Adams

Clinical Engineer

Cyberonics, Inc

100 Cyberonics Blvd.

Houston, Texas 77058

Tel: 1.800.332.1375

Direct: 281.727.2571

Fax: 281.853.2735

www.cyberonics.com

This e-mail message may contain confidential or privileged information, including sensitive patient-related information protected by state and federal laws. If you are not the intended recipient of this message, or an authorized representative of the intended recipient, you are prohibited from reviewing, copying, or distributing this message, its attachments, or any information contained in this message. If you received this message in error, please notify the sender immediately by replying to the message and delete this message from your system.

---

This email has been scanned for email related threats and delivered safely by Mimecast.
For more information please visit http://www.mimecast.com

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 2:40 AM
To: 'Dylan Adams'
Cc: Dr. Ely Pelta; Daniel Moore, CEO - Cyberonics; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics
Subject: RE: Joyce's VNS Device

Hi Dylan,

Thank you for the telephone call and email yesterday clarifying the battery status Joyce’s model 104 implant.  At the time of your call I was driving to my doctor as I’ve been under the weather and couldn’t take any notes and therefore I was unable to respond to you until now.  Your prompt response and that of your fellow associates is greatly appreciated in resolving several recent issues expeditiously.

By copy of this communication to Joyce’s attending physician, Dr. Ely Pelta, I shall similarly update him as to your company’s updated programming of his newest handheld computer as it relates to the battery status as you explained it to me and the fact Dr. Pelta has other patient(s) who will similarly need their prosthesis interrogated.

“While there are no words to describe the battery status following the interrogation of Joyce’s M104 device, a battery indicator symbol does appear in the upper left hand corner. Additionally, running of diagnostic tests will allow you to see the battery life status at the bottom of the screen in word form. Given that Joyce’s battery indicator is colored green the statement would read, “IFI = no”, indicating that Joyce’s device is not at a low battery condition. If you are interested in an estimate of longevity for the battery please let me know and we can facilitate a battery life calculation. Please do not hesitate to reach out to me directly at (281) 727-2571.”

Joyce’s previous model 102R at the same settings was in use closing in on 9 years and because of certain health insurance issues at the time we did not want to take any chances that her battery would deplete.  We previously experimented deactivating her device and within 2 weeks she rapidly declined into a severe depression.  Within about 2 days of reactivation of the prosthesis she was depression free once again and we have not looked back.  Her more recent model 104 was implanted October 2013 so it will be unnecessary to trouble you at this time for a “battery life calculation” but I shall record that terminology and process in my records when I feel the time becomes necessary for replacement.  So thank you for that piece of information too.

Once again, I cannot fully express my appreciation to all you folks for the very prompt and expeditious handling and assistance you all have shared and executed on our behalf.  Most importantly despite Joyce’s other advancing neurological challenge PSP (Progressive Supranuclear Palsy) which would be cause for severe depression Joyce continues in a depression free state for which I am eternally grateful to all who have assisted us in one way or another to give her a reasonable quality of life.  Thank you, thank you and thank you…

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: EDP [mailto:(Redacted)]
Sent: Saturday, July 18, 2015 7:15 AM
To: Herbert Stein
Subject: Re: Joyce's VNS Device

Thank you herb !
Sent from my iPhone

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 3:11 AM
To: Daniel Moore, CEO - Cyberonics
Cc: Dr. Ely Pelta; Bryan Olin, Ph.d; Dr. Mark Bunker; Susan Dotson, L.V.N., Sr. Manager - Cyberonics; Dylan Adams - Clinical Engineer - Cyberonics
Subject: Publicly sharing recent correspondence...

Dear Dan et al,

As you are aware from my recent correspondence with your associates we ran into a couple of issues which were expeditiously resolved by your staff.

I would like your permission to share the correspondence I have recently had between Bryan, Susan and Dylan publicly in what I consider a truly favorable light as to how your organization has functioned expeditiously to help one of its patients and physician.

Putting our differences aside as to the legal issues of the Guarantee and the anti-kickback statutes which I blogged previously I do try to maintain a balanced perspective regarding the VNS Therapy as well as all treatments and I think this is an opportunity for me to favorably blog the good your organization has demonstrated.

Please let me know if this is acceptable to you and your staff.

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

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

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: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Saturday, July 18, 2015 3:56 PM
To: Herbert Stein; Dan Moore
Cc: Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: RE: Publicly sharing recent correspondence...

Dear Herb,

Thank you for the kind words.  We always appreciate the feedback on the level of service we provide-it is great to see Dylan and Susan’s work recognized.  However, please don’t feel any obligation to include this in your blog.  Our perspective is that this is simply the level of service that we owe our patients, caregivers and physicians as a medical device company.

As always, don’t hesitate to contact us with any further questions.

Best regards,

Bryan

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

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, July 18, 2015 11:20 PM
To: 'Bryan Olin'; 'Dan Moore'
Cc: 'Dr. Ely Pelta'; 'Mark Bunker'; 'Susan Dotson'; 'Dylan Adams'
Subject: RE: Publicly sharing recent correspondence...

Hi Bryan,

I don’t feel any obligation but when I undertook some 15 years ago sharing our experiences, my research and collaborations with many of the patients and professionals as it related to VNS Therapy for Depression I did so because Joyce and I were intimately involved with the therapy.  While doing so I felt by sharing with others my accumulated knowledge from the viewpoint of a support person as well as a long-time mental health advocate/activist that it might benefit someone else.  I also endeavored to share both pro and con as well as the good or bad as unbiasedly as possible and where I felt it appropriate to inject my personal opinion(s).

I have also been given permission in many instances through the years to publicly share personal correspondence both from patients and professionals to emphasize both sides of the coin and to establish creditability of the website(s) I established.  Then too, I have also been requested to not publicly share many communications which I have also complied with.  I share Joyce and my personal address information, as you will note, along with my correspondence to help establish our creditability and the fact we have nothing to hide and are real people unlike some other sites, participants and webmasters I have encountered through the years.   

Certainly I have been assertive and outspoken while trying to be respectful about several issues not favorable to Cyberonics while on other matters I have expressed my gratitude and admiration.  I am well aware of patients who have been extremely dissatisfied with both your company and therapy and I have freely shared that information too.  I now have experienced another instance which is both pro and good, in my opinion, and I would like to share that information by presenting the quick action on your part, late on a Sunday evening, and the prompt follow up by your other associates to overcome these two (2) recent issues and I can think of no better way to illustrate those facts than by sharing our various recent communications.

I do appreciate and thankfully acknowledge your taking your valuable time and consideration to address this matter too.

Once again, may I be allowed to publish the recent correspondence I’ve had with you, Susan and Dylan?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

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

From: Bryan Olin [mailto:Bryan.Olin@cyberonics.com]
Sent: Sunday, July 19, 2015 11:33 AM
To: Herbert Stein
Cc: Dan Moore; Dr. Ely Pelta; Mark Bunker; Susan Dotson; Dylan Adams
Subject: Re: Publicly sharing recent correspondence...

Dear Herb,
It would be fine if you would like to share the experience in your blog.
Best regards,
Bryan
Sent from my iPhone

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

And in the words of the late Paul Harvey and now you have “The Rest of the Story”.

Herb

In all fairness and balanced reporting...

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

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

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

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

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

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

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

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

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

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

 

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.

BMC Psychiatry. 2015 Mar 31;15(1):64.

Vagus nerve stimulation for treatment-resistant mood disorders: a long-term naturalistic study.

Albert U¹, Maina G², Aguglia A³, Vitalucci A⁴, Bogetto F⁵, Fronda C⁶, Ducati A⁷, Lanotte M⁸.

Author information

• ¹Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. umberto.albert@unito.it.
• ²Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. giuseppe.maina@unito.it.
• ³Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. andrea_aguglia@yahoo.it.
• ⁴Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alberto.vitalucci@unito.it.
• ⁵Rita Levi Montalcini Department of Neuroscience, Mood and Anxiety Disorders Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. filippo.bogetto@unito.it.
• ⁶Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. chiara.fronda@unito.it.
• ⁷Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. alessandro.ducati@unito.it.
• ⁸Rita Levi Montalcini Department of Neuroscience, Neurosurgery Unit, University of Torino, via Cherasco 11, 10126, Turin, Italy. michele.lanotte@unito.it.

Abstract

BACKGROUND:

Limited therapeutic options are available for patients with treatment-refractory major depression who do not respond to routinely available therapies. Vagus nerve stimulation showed adjunctive antidepressant effect in chronic treatment resistant depression, even though available studies rarely exceed 2-year follow up. We report a naturalistic 5-year follow up of five patients who received VNS implant for resistant depression (3 patients with major depressive disorder and 2 with bipolar disorder).

METHODS:

Response was defined as a reduction of the 17-item HDRS total score ≥50% with respect to baseline, remission as a score ≤7.

RESULTS:

Response and remission rates were both 40% (2/5) after 1 year, and 60% (3/5) at 5 years. Two patients withdrew from the study because of side effects or inefficacy of stimulation.

CONCLUSIONS:

Our case series showed that long-term VNS may be effective in reducing severity of depression in a small but significant minority of patients, although two patients had stimulation terminated because of adverse effects and/or refusal to continue the study.

PMID:

25884606

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/25884606

Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue)

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, February 28, 2015 3:18 PM
To: Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: Battling Florida Blue...

To Joyce’s fellow patients et al,

I need your help.  If anyone out there reading this message knows the direct email address for Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) I would gratefully appreciate your assistance by sending me the address.

I am trying to advocate for a fellow VNS Depression patient being denied coverage for the replacement of his/her prosthesis as a private pay subscriber.

Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield,

I would appreciate if you could give me Mr. Geraghty’s direct email address.  I am aware and thank you for the assistance you previously gave to one of your VNS Depression patients by paying for her replacement and based upon what she had told me you did so stating, “continuity of care”.  At the time I did not fully understand the significance of the term as I now know it establishes a medical precedence and practice which Medicare/Medicaid and the private insurance carriers should have been adhering to.  I would also ask, if possible, if you would contact your fellow CEO and apprise him of the patient that his company has been denying medical coverage.  If necessary I’m sure the patient would supply you with personal information so that Mr. Geraghty would see to the expediting of this case.  Just let me know.

It is truly shameful and anxiety ridden that these implanted patients with a medical device and I have to shamefully fight tooth and nail with our last once of strength for that which already exists in medical doctrine and practice buried somewhere in the vestiges of HHS and no one knowledgeable enough throughout these bureaucracies to come forth to rightfully help these patients and rectify the situation by stating, “continuity of care”.

Shameful, shameful, shameful on all you bureaucrats who sit back, spout platitudes, collect your checks and really make no effort to reach out and truly help with a few exceptions, that’s unfortunately the way I see things based upon my lengthy advocacy for these patients.

Shame on you all for not comprehending what it is like to help keep someone alive!

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Still battling Florida Blue…

From: (redacted)
Sent: Saturday, February 28, 2015 9:58 AM
To: Herbert Stein
Subject: RE: DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION

Hi Herbert.
Got your call and the email updates. Thank you.
I take it from the document, this decision is not overturning the 2013 to cover battery replacement but rather rejects the argument that the previous decision to stop coverage of new implants was not based on full record of evidence. Is this your thoughts?
I am working with a case manager at Cyberonics and I am awaiting a predetermination of benefits. I expect it will be denied. I have starting collecting all my medical records. Also I have started a draft of a personal statement.
My next step will be to find the direct contact info of Florida Blues CEO.
I will keep you up yo date if how this transpires.
Again thank you for your continued support to all if us.
Sincerely
(Redacted)
Sent from my Windows Phone

---

 

From: Herbert Stein [Redacted]
Sent: Saturday, February 28, 2015 12:57 PM
To: (Redacted)
Subject: RE: DECISION THAT THE NCD RECORD IS COMPLETE AND ADEQUATE TO SUPPORT THE VALIDITY OF NCD 160.18(C), VAGUS NERVE STIMULATION

(Redacted),

My understanding of this recent appeal decision is that they are upholding the May 4, 2007 decision to not pay for any implants or care of new patients on or after that date.

While denying insurance coverage to new patients it goes on further to state for the first time in this recent appeal decision, in writing, the care and replacement of the device rightfully for Medicare/Medicaid patients implanted prior to May 4, 2007 under the doctrine or law of “continuity of care”.  I further interpret this decision to mean that the private health insurers, who normally follow CMS’s lead, should also follow the “continuity of care” doctrine as quoted below:

(1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).

Not being a legal authority I can only express my opinion based upon my readings but were I in your position I certainly would emphasize and strongly hang my hat on the above information and decisions to encourage, enforce and coerce your insurance carrier to relent and do the right thing.

If you’re able to obtain an email address for Florida Blue CEO I’ll jump immediately on advocating for your cause.

I’m here and available to encourage and support your efforts.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

RE: Response to Your January 12, 2015 Email

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, January 25, 2015 6:33 PM
To: 'Turner, Courtney (CMS/OHI)'
Cc: 'Burwell, Sylvia M. (HHS/OS)'; 'Cavanaugh, Sean (CMS/CM)'
Subject: RE: Response to Your January 12, 2015 Email

Dear Courtney,

Thank you as always for responding to my communications.  I am tardy in reply to you as we were away cruising and just returned home today.

I have been carefully following the DAB website for any announcement relating to their recent decision on VNS Therapy for Depression.  I was just trying to touch all bases in the event I may have missed and/or overlooked any issuance of a formal document.

I am, as you know, also very disappointed in that once again any wording that I’ve read so far does not encompass all the patients implanted prior to May 4, 2007.  What I’ve read appears to leave out the patients that were previously covered by private insurers (i.e. United Healthcare) who wish to continue with the therapy and that again are a moral and unconscionable oversight on the part of DAB and our voluminous government agencies.  It is as if our government bureaucracy can’t get anything right on the first go-round or the second for that matter.

As always, I wish to thank you for your outstanding efforts and help on behalf of Joyce and the other VNS patients formerly suffering Major Depressive Disorder who have been able to obtain replacement devices and care so that they may continue enjoying lives either free of depression or greatly improved mental state.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

From: Turner, Courtney (CMS/OHI) [mailto:Courtney.Turner@cms.hhs.gov]
Sent: Wednesday, January 21, 2015 10:23 AM
To: Herbert Stein
Cc: Burwell, Sylvia M. (HHS/OS); Cavanaugh, Sean (CMS/CM)
Subject: Response to Your January 12, 2015 Email

Good Morning Mr. Stein,

Happy New Year! I hope you had a nice holiday season.

Thank you for your below inquiry.  I apologize for the delayed response.  Please see the attached letter regarding your concern.

Sincerely,

Courtney

Courtney S. Turner, MPH

Office of Hearings and Inquiries

Medicare Ombudsman Group

Division of Medicare Ombudsman Assistance

Office: 410-786-4593

Confidential or Privileged:  This communication contains information intended only for the use of the individuals to whom it is addressed and may contain information that is privileged, confidential, or exempt from other disclosure under applicable law.  If you are not the intended recipient, you are notified that any disclosure, printing, copying, distribution, or use of the contents is prohibited.  If you have received this in error, please notify the sender immediately by telephone or by returning it by reply mail and then permanently delete the communication from your system.  Thank you.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, January 12, 2015 1:47 PM
To: Turner, Courtney (CMS/OHI)
Cc: Burwell, Sylvia M. (HHS/OS); Cavanaugh, Sean (CMS/CM)
Subject: "A decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services."

Dear Courtney,

We wish you and your family a very Happy, Healthy, Peaceful and Prosperous New Year.

I would appreciate if you could help me by sending to me a copy of the document of the recent DAB decision relating to VNS Therapy or if you could cite a link containing the decision for me to download.  To date I have been unable to find the information and/or document.

The only indication of the decision is contained in the press release from Cyberonics.

As always, thank you on behalf of Joyce and the other patients for the help and the compassion you’ve shown too many of us in desperate need.  What is now left for me to accomplish is to obtain and correct the continuing oversight and denial by the insurance carriers for their private pay patients who wish to continue with the VNS Therapy for Depression who were also implanted prior to May 4, 2007.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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

Message for Stephen J. Hemsley - CEO, United Healthcare

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, January 12, 2015 4:06 AM
To: Stephen J. Hemsley - CEO, United Healthcare; Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director
Subject: VNS Therapy for Depression...

Dear Mr. Hemsley,

I had to get this quick note off to you because I just received this past evening an email from a husband seeking information and help from me for his wife.  In his brief note to me he says,

“As I said earlier she had the VNS implanted and the changes in her were amazing, she went from a person unable to hold down a job to a person able to achieve anything she has attempted.  She decided she felt well enough to attempt returning to college and has since received her degree has a Registered Nurse.”

I haven’t yet made contact with the gentlemen as I didn’t read his message until a little while ago but I certainly know who to write to and who could quickly remedy this couples problems.

Maybe you didn’t read the latest news although I informed you in a previous communication. 

Cyberonics Provides Update On Departmental Appeals Board Decision Regarding Coverage Of VNS Therapy® System In Treatment-Resistant Depression

HHS and CMS are going to cover all the Medicare/Medicaid patients implanted prior to May 4, 2007.  You guys are quick to have denied coverage based upon that decision so why is it that your company is not complying with this newer decision.  Don’t you have a conscience?  Don’t you think it is the morally correct thing to do that is to take care of your insured?  Those patients wishing to continue the therapy are benefiting from the therapy by maintaining their wellness and reducing the costs to you and the other insurers.  This therapy long ago is no longer “experimental” for these people.  It is truly an effective therapy like no other.  I’m sure as CEO you’re capable and/or your voluminous staff of crunching numbers.  These patients are saving your company money.  Contrary to your hack consultant’s opinion, Dr. Amy Schneider, whose name could easily be substituted for Dr. Tim Jack in Correspondent Scott Pelley’s reporting of December 14, 2014 entitled “Denied”.  Your consultant doesn’t know what the hell she’s talking about as I’m sure she’s never examined any of these patients.  Also of interest she writes opinions on cancer treatments.  What a sad joke in my opinion and a practice Pelley rightfully exposed in his reporting.

Don’t you think it time to have some compassion and finally do the right thing and approve care and replacement therapy for your private pay patients too?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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

NOTICE OF CONFIDENTIALITY / Disclaimer

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

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

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