"Joyce, please wait. I'm expecting an important call and then we'll go shopping."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, January 31, 2014 11:00 AM
To: Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: "Joyce, please wait. I'm expecting an important call and then we'll go shopping."

To Joyce’s fellow VNS Therapy patients et al,

Apparently and once again my efforts, advocacy as well as my emails are not going unread nor unheeded.  

"Joyce, please wait.  I'm expecting an important call and then we'll go shopping," was my response to Joyce as I shared quick emails (see below) with Mr. Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services.

In my “off-the-record” telephone conversation yesterday at about 3:00 PM with Jonathan he wanted to let me know my messages are all being read as well as some additional information he wanted to share.

Once again I can only share my understanding and interpretation of what was discussed without quoting directly. 

I feel strongly based upon Jonathan’s word and what his agency have already effectively done for a number of the VNS Medicare/Medicaid patients that they are endeavoring to somehow continue by also assisting the private pay patients.  I gathered from the conversation what I’ve come to know that these are very large government agencies guided by rules, regulations and protocols and that it may take a little time to reach our objective.  As an analogy I would liken it to steering a huge oil tanker; they can’t turn on a dime and it takes considerable advanced planning and preparation to steer left or right.  In my opinion, hopefully we shall get there but I’m unable to put a frame on the matter.

In the meantime I shall continue my advocacy and focus toward the two current CEO’s where I’ve been told by the patients that have communicated with me that their companies have declined private payer(s).  I do so in the hope these executives will come to understand the seriousness and potentially deadly consequences of inaction and/or denial and the need for compassion, humanism and doing the right thing.  As a former CEO of a considerably smaller business enterprise I had the authority and ability to make things happen quickly as I am sure so do Mr. Stephen Hemsley, CEO, United Healthcare and Mr. Chet Burrell, President & CEO CareFirst BlueCross BlueShield.

I ask these gentlemen to please make things favorably happen for your existing VNS patients who require replacement without having to wait for any formal government document and/or communication to effectuate this process and/or policy within your organizations.  Inaction or denial may well prove fatal to some of these patients who otherwise were doing well.

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: Blum, Jonathan D. (CMS/CM) [mailto:Jonathan.Blum@cms.hhs.gov]
Sent: Thursday, January 30, 2014 2:44 PM
To: Herbert Stein
Subject: RE: What is it that you and your agency doesn't understand?

I will call you in a few minutes.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 2:42 PM
To: Blum, Jonathan D. (CMS/CM)
Subject: RE: What is it that you and your agency doesn't understand?

Jonathan,

Any chance of calling right now?  Home 954-349-8733

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: Blum, Jonathan D. (CMS/CM) [mailto:Jonathan.Blum@cms.hhs.gov]
Sent: Thursday, January 30, 2014 2:39 PM
To: Herbert Stein
Subject: RE: What is it that you and your agency doesn't understand?

Mr. Stein: is there a good time to give you a call today?  If so, let me know the right number.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 12:12 PM
To: Sebelius, Kathleen (HHS/OS)
Cc: Blum, Jonathan D. (CMS/CM); Larrick, Amy (CMS/CM); Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: What is it that you and your agency doesn't understand?

Dear Madam Secretary Sebelius,

Are you so beyond reproach that after numerous emails to you that you lack the common decency and courtesy of an acknowledgement or response from either you or one of your subordinates?  Is such a response also beyond your humanism and the scope of your position, agency or mission?

I write to you not asking anything for myself but I do so on behalf of seriously ill patients.  I do so because CMS, one of the agencies under your domain seriously screwed up.  I do so because their screw up was egregious, unconscionable, immoral and obviously lacking much wisdom and foresight.

The FDA, approves a therapy.  Then two years later another agency under your dominion, CMS, denies medical coverage for an FDA approved therapy and from my understanding the first time such an event took place.  The health insurance industries follows CMS lead and denies coverage to their subscribers.  We are then left with implanted medical devices in volunteer study subjects and patients who obtained the therapy as study subjects or by way of their insurance coverage during the two year gap between FDA approval and CMS denial.  Absolutely brilliant thinking on the part of our convoluted government agencies and its voluminous staff of administrators and so called expert personnel (stated sarcastically).

It is almost 7 years from the date CMS first denied coverage.  To correct this blatant oversight CMS has apparently understood the gravity and seriousness of this error and/or oversight and has partially corrected the situation by issuing a “Stealth Decision”.  CMS has acted responsibly and is caring for these patients but the private health insurers have not followed suit.

I did learn from CMS that they have no authority over the private health insurance carriers.  I can understand and accept the scope of their authority.  What I can’t accept is the fact I requested CMS, Ms. Amy Larrick, to please call the private health insurance carriers or to write to them explaining their recent reversal decision to care for all the Medicare/Medicaid patients needing help for all those implanted on or prior to their previous denial date of May 4, 2007.  It was further explained to me that a meeting was held within CMS and the decision was made that they would not call or write.  What I also cannot accept or fathom, i.e. United Healthcare managed Medicare programs have paid for patient replacement and care and the same company has denied care to private payers?  How is that possible and not a violation of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)? Does this not smack of discrimination?

Is there not anyone within your various agencies that can fully grasp the seriousness of what is transpiring?

What you also may be lacking in your knowledge and wisdom is the fact these patients responded and obtained efficacy from VNS Therapy for multiple years and now that their pulse generators (batteries) are depleting they are returning to the abyss of depression, despair and agony and suicidal ideations.  How in good conscience can you or anyone reading my missives still sit by and do nothing when we know there is an effective treatment being denied these patients.  Too boot, there is a substantial cost savings not only to the government but the insurance carriers as well in maintaining their long-term wellness.  Add to the fact a number of these patients have been able to maintain employment, pay taxes and are now facing losing both their wellness and employment.

Therefore, my goal of having health insurers change their policy toward these patients has only partially been achieved and my reason for hounding you and your agency to act responsibly and now!

“HHS Operating Divisions are responsible for implementing programs that touch the lives of all Americans. Whether it’s providing millions of children, families, and seniors with access to high-quality health care, helping people find jobs and parents find quality child care, keeping the food on Americans’ shelves safe and infectious diseases at bay, or exploring new frontiers of biomedical research, we are working every day to give Americans the building blocks they need to live healthy, successful lives.”

You “are working every day to give Americans the building blocks they need to live healthy, successful lives.”  Oh really, you’ve fooled me.  I couldn’t tell by your total lack of response, concern or effort for this small group of seriously ill patients.

I know little about the bureaucracy of your agency or for that matter the workings of any government agency other than to opine that I am truly amazed that anything worthwhile or effective ever seems to be accomplished.  I also question whether you or any of your staff take the time to read what you publish on your webpages.  If so then you would know and understand that I am not asking for anything outrageous or beyond the scope of your agencies capabilities.

I am again asking you to please notify the private health insurance carriers of CMS policy change in their “Stealth Decision” as it relates to this unique group of seriously ill patients.  Do what is right only do it now!

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.

What is it that you and your agency doesn't understand?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 30, 2014 12:12 PM
To: Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: What is it that you and your agency doesn't understand?

Dear Madam Secretary Sebelius,

Are you so beyond reproach that after numerous emails to you that you lack the common decency and courtesy of an acknowledgement or response from either you or one of your subordinates?  Is such a response also beyond your humanism and the scope of your position, agency or mission?

I write to you not asking anything for myself but I do so on behalf of seriously ill patients.  I do so because CMS, one of the agencies under your domain seriously screwed up.  I do so because their screw up was egregious, unconscionable, immoral and obviously lacking much wisdom and foresight.

The FDA, approves a therapy.  Then two years later another agency under your dominion, CMS, denies medical coverage for an FDA approved therapy and from my understanding the first time such an event took place.  The health insurance industries follows CMS lead and denies coverage to their subscribers.  We are then left with implanted medical devices in volunteer study subjects and patients who obtained the therapy as study subjects or by way of their insurance coverage during the two year gap between FDA approval and CMS denial.  Absolutely brilliant thinking on the part of our convoluted government agencies and its voluminous staff of administrators and so called expert personnel (stated sarcastically).

It is almost 7 years from the date CMS first denied coverage.  To correct this blatant oversight CMS has apparently understood the gravity and seriousness of this error and/or oversight and has partially corrected the situation by issuing a “Stealth Decision”.  CMS has acted responsibly and is caring for these patients but the private health insurers have not followed suit.

I did learn from CMS that they have no authority over the private health insurance carriers.  I can understand and accept the scope of their authority.  What I can’t accept is the fact I requested CMS, Ms. Amy Larrick, to please call the private health insurance carriers or to write to them explaining their recent reversal decision to care for all the Medicare/Medicaid patients needing help for all those implanted on or prior to their previous denial date of May 4, 2007.  It was further explained to me that a meeting was held within CMS and the decision was made that they would not call or write.  What I also cannot accept or fathom, i.e. United Healthcare managed Medicare programs have paid for patient replacement and care and the same company has denied care to private payers?  How is that possible and not a violation of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA)? Does this not smack of discrimination?

Is there not anyone within your various agencies that can fully grasp the seriousness of what is transpiring?

What you also may be lacking in your knowledge and wisdom is the fact these patients responded and obtained efficacy from VNS Therapy for multiple years and now that their pulse generators (batteries) are depleting they are returning to the abyss of depression, despair and agony and suicidal ideations.  How in good conscience can you or anyone reading my missives still sit by and do nothing when we know there is an effective treatment being denied these patients.  Too boot, there is a substantial cost savings not only to the government but the insurance carriers as well in maintaining their long-term wellness.  Add to the fact a number of these patients have been able to maintain employment, pay taxes and are now facing losing both their wellness and employment.

Therefore, my goal of having health insurers change their policy toward these patients has only partially been achieved and my reason for hounding you and your agency to act responsibly and now!

“HHS Operating Divisions are responsible for implementing programs that touch the lives of all Americans. Whether it’s providing millions of children, families, and seniors with access to high-quality health care, helping people find jobs and parents find quality child care, keeping the food on Americans’ shelves safe and infectious diseases at bay, or exploring new frontiers of biomedical research, we are working every day to give Americans the building blocks they need to live healthy, successful lives.”

You “are working every day to give Americans the building blocks they need to live healthy, successful lives.”  Oh really, you’ve fooled me.  I couldn’t tell by your total lack of response, concern or effort for this small group of seriously ill patients.

I know little about the bureaucracy of your agency or for that matter the workings of any government agency other than to opine that I am truly amazed that anything worthwhile or effective ever seems to be accomplished.  I also question whether you or any of your staff take the time to read what you publish on your webpages.  If so then you would know and understand that I am not asking for anything outrageous or beyond the scope of your agencies capabilities.

I am again asking you to please notify the private health insurance carriers of CMS policy change in their “Stealth Decision” as it relates to this unique group of seriously ill patients.  Do what is right only do it now!

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.

"It was once said that the moral test of government is how that government treats...those who are in the shadows of life, the sick, the needy and the handicapped."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, January 29, 2014 7:47 AM
To: Madam Secretary Kathleen Sebelius, United States Secretary of Health and Human Services
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: "It was once said that the moral test of government is how that government treats...those who are in the shadows of life, the sick, the needy and the handicapped."

Dear Madam Secretary Sebelius,

Yesterday I received an email response from my son-in-law in regards to the previous email I sent to you entitled “The Buck Stops here!” in which he said,

 

“When are you throwing your hat into the Gubernatorial race?

I'll move down there to vote for you. ”

 

I in turn replied to my son-in-law,

 

“I thought I was done with this until the last two weeks when I got four requests for help both from patients and doctors.

The bureaucracy and crap that goes on in DC is unfathomable.  It is truly amazing anything ever gets done in this country.

I’d just like to retire to some peace and quiet.”

 

I should have properly stated “I’d just like to retire once again to some peace and quiet”.

The advocating for the VNS Therapy depression volunteer study subjects  expanded to include all the implanted VNS depression medical device patients who were short changed by the sponsor (Cyberonics), the FDA, CMS and all the medical professionals who established the original protocols for these studies and through subsequent implants after the FDA approval through their oversight to provide medical care for these patients.  Honestly Madam Secretary while you did look resplendent in your blue suit this past evening I would like to retire once again knowing you took proper care of these patients.

What started as a self-serving cause for me to obtain health insurance coverage for my spouse grew into an advocacy for a small group of VNS Therapy depression patients.  These patients are responding and obtaining efficacy, as is my spouse, as never before while also achieving a reasonable quality of life for themselves.  The FDA approved this therapy for both Epilepsy and Depression.  CMS early on only approved the therapy for epilepsy while denying coverage for depression and only up until recently in their “Stealth decision” have they issued an approval for depression.  What remains is to overcome the denials and discrimination on the part of a number health insurance carriers and the reason I am looking to you to rectify the balance of this outrageous injustice.

Next to your mission statement on your webpage is a quote: 

http://www.hhs.gov/about/

The patients for whom I advocate are “…those who are in the shadows of life, the sick, the needy and the handicapped.”

I truly hope this quote and the words contained therein, you and your agency adhere to and act upon and is not posted on your site to look pretty and simply fill space on a webpage.  Your fellow Americans need your help; now!

It is time for you to respond and finally act responsibly and exhibit leadership on behalf of these sick patients.  Please issue a communication (mandate, directive and/or some piece of paper) to all the health insurance industry to morally and rightfully cover these patient subscribers and not discriminate in any manner against this mental health group in their dire need for care.

Please truly treat these patients (your fellow Americans) with respect and care that they deserve and in doing so allow me to return to my retirement, once again, so that I may better care for my spouse.

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.

“The Buck Stops here!”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, January 28, 2014 12:09 PM
To: Madam Secretary Kathleen Sebelius - HHS
Cc: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Subject: The Buck Stops here!

Dear Madam Secretary Sebelius,

Is there not someone in all of the bureaucracy within your domain who remembers former President Harry Truman’s desk sign   and who comprehends the intent of the message the sign was meant to convey.  Well I do remember the sign, intent and meaning and hopefully so will you.

After numerous past emails to both you and Mr. Jonathan Blum and his staff, Jonathan took the moral and rightful high ground in assuring medical coverage for the small group of VNS Therapy depression volunteer study subjects and patients.  These patients were egregiously, immorally, unconscionably and/or by oversight or stupidity on the part of CMS in their earlier decision of 2007 to not grandfather care.  These patients were implanted with medical devices and subsequently denied health insurance coverage which Jonathan recently understood and acted upon to do the morally correct thing by covering these patients; although it has only partially been successful.

In CMS more recent decision, which I now refer to as a “Stealth Decision”, a significant number of Medicare/Medicaid subscribers and 1 or 2 private insurance subscribers that I am aware of have obtained replacements and care covered by their health insurance.  Unfortunately the message and intent of the “Stealth Decision” has not reached all the health insurance carriers who at first were quick to jump upon the bandwagon of coverage denial based upon the earlier CMS 2007 decision.  Now that CMS has changed their position as indicated in the “Stealth Decision” it is now being brought to my attention that a number of private health insurance companies have been denying VNS patients their replacements and proper care.

Hopefully “The Buck Stops here!” will finally take effect with your understanding and that a message (mandate) goes forth from your agency to all the health insurance industry that this small group of VNS Therapy depression patients should rightfully be covered by their medical insurance carriers if they and their attending physicians choose to continue the therapy, care and/or explant.

I also think it incumbent upon you and your agency to also stress that non-compliance is both discriminatory and in violation of the intent of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

I have advocated vociferously this past year not to just see that only some of these VNS Therapy depression patients are cared for.  Instead all who were previously implanted and have responded and obtained efficacy from the therapy should rightfully be able to continue with the therapy if they so choose and not be outright discriminated against and/or denied by any health insurance company.

May I also take the liberty of reminding you and those who read my messages that “The mission of the Department of Health and Human Services is to help provide the building blocks that Americans need to live healthy, successful lives…The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.”  Mr. Jonathan Blum and his agency have done their part and it is now your responsibility and that of your agency to execute your mission statement and mandate that all the health insurance companies follow CMS revised decision and immediately fulfill your mission statement to our fellow Americans to live healthy, successful lives.  It is your responsibility to not only protect the health of these Americans but to maintain and continue the wellness they’ve already achieved through their VNS Therapy.

Madam Secretary, it is time that you no longer sit back but rightfully vocalize and champion CMS newer decision for these patients.  Please inform all the health insurance carriers to comply and allow care to these patients, now! 

I am available 365/24/7 should you have any questions of me regarding this very urgent matter.

“The Buck Stops here!” with you and now!

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.

Once again another life hangs in the balance...

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, January 27, 2014 2:27 PM
To: Chet Burrell, President & CEO CareFirst BlueCross BlueShield
Cc: Madam Secretary Kathleen Sebelius - HHS; Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid; Stephen J. Hemsley - CEO, United Healthcare
Subject: Once again another life hangs in the balance...

Dear Mr. Burrell,

Apparently you and your company are also unaware of a recent informal decision rendered by CMS to insure that all VNS Therapy depression patients implanted on or before May 4, 2007, the date CMS rendered a determination to not cover VNS Therapy for the depression indication, would receive medical care, replacement and/or explant.  CMS egregiously, immorally, unconscionably and/or by oversight or stupidity rendered that 2007 decision without grandfathering care for these volunteer study subjects and patients now implanted with a medical device. 

In their more recent decision CMS conscionably is trying to rectify this oversight as they’ve come to learn that those patients wishing to continue with the therapy are long-term responders obtaining efficacy over multiple years and from the standpoint of economics saving considerable sums of monies for the government (Medicare/Medicaid) as these patients no longer require very costly multiple-yearly hospitalizations, numerous doctor visits and exorbitant sums of money for ineffective and refractory psychotropic medications and other therapies.

To which I also add that in all likelihood your company is discriminating and in violation of the intent of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

More specifically, I am a very, very long-time mental health advocate and activist for my spouse and others and currently advocating on behalf of one of your subscribers.

Kimberly Elizabeth Meek

618 Lexington Place NE

Washington, DC 20002

Cell: 202-340-5766

Fax: 202-478-2679

k.meek@mac.com

Insurance: 

CareFirst Blue Choice POS Open Access

Mail Administrator

PO Box 14115

Lexington, KY 40512-4115

Member ID: GOM830 17 4726

Group #: 5800049-DC10

Ms. Kimberly Meek requires an immediate favorable decision from your company to obtain surgery for the replacement of her depleted pulse generator and a re-implant of her VNS prosthesis in order to maintain her previous wellness and to prevent her possible death.

I ask that you and/or your appropriate subordinate(s) immediately contact Mr. Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services at either of his two offices [(202) 690-6301 DC or (410) 786-4164 Baltimore)] or Ms. Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid at either of her two offices [(202) 690-5742 DC or (410) 786-2585 Baltimore] to validate that which I have presented to you.

More importantly, your immediate assistance and cooperation in trying to save Ms. Kimberly Meek’s life is a matter of grave urgency easily rectified by your company’s prompt authorization and approval of her rightful surgery.

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.

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"The death of common sense"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Saturday, January 25, 2014 2:52 PM
To: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: "The death of common sense"

Dear Jonathan,

As a very, very long-time mental health advocate and activist I have been blessed and fortunate to maintain long-time correspondences and collaborations with many lay-people and medical professionals seeking the same goals.  Some of these people are unfortunately challenged and disabled by serious depressive illnesses while others either care give and/or support those challenged and otherwise live rather normal lives as well as a considerable number of very compassionate and caring medical professionals who I include in my advocacy and email distributions.

I just today received an interesting response to one of my recent emails.  A friend responded and simply hit the nail on the head.  “The death of common sense” (please see the email dated “Saturday, January 25, 2014 10:59 AM” reply to me which I’ve copied, cut and pasted below).  You issued an informal decision to rightfully cover the VNS Therapy depression volunteer study subjects and all those other patients implanted on or before your national decision to deny coverage.  As you already know, my spouse Joyce and a number of other Medicare/Medicaid patients and one or two health insurance private pay patients I am aware of are truly appreciative of your (CMS) informal decision of September 26, 2013 as they were finally able to obtain replacement and medical coverage for their depleted pulse generators.

As it was explained to me by Ms. Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid  that your change in policy would not be covered by a formal document and that a procedure would be instituted by way of those depression patients running into obstacles from their insurance carriers would be able to call directly to Amy who would assist in obtaining medical coverage.  Amy made a point of also explaining that she (CMS) had no control or authority over the private health insurance carriers.  What Amy and/or CMS was remiss in explaining to me at the time was that she (CMS) would not call, write, explain and/or share information regarding the change in policy by CMS to the private health insurance carriers and what I shall now refer to as your (CMS) “Stealth Decision” of September 26, 2013 to try to overcome the egregious, immoral, and discriminatory oversight in your past decision by not grandfathering care for this unique patient group for medical coverage.

Your (CMS) “Stealth Decision” has only been partially successful.  What about these other patients who are also not at fault being left with an implanted medical device that no one wants to care for?  How in good conscience, once again, can you (CMS) not advise the private health insurance carriers of your recent change in policy?  This is not experimental as some of the private health insurance carriers have determined based upon your May 4, 2007.  This is in fact a demonstrated beneficial therapy (encompassing multiple years of successful use) to these patients who want to continue the therapy and are irrationally being denied coverage and are being forced back into the abyss of the devastating “Black Hole” of depression and suicidal ideations.

“The death of common sense” more than aptly describes and covers the lunacy I read, see and hear once again in denying these unique and seriously ill patients replacement coverage and the fact your agency will do no nothing to inform these private carriers.  Am I truly hearing correctly?

Doesn’t anyone think these ramifications through to a clear and logical conclusion anymore?

The private health insurance carriers quickly denied coverage with your 2007 decision.  How can they possibly reconsider altering and/or changing their policy if you fail to update and inform them of your recent policy change?

Jonathan, I know you care and are compassionate.  You told me so.  I believed you.  You and your agency have already demonstrated your sincerity in wanting to help.  Then do something to overcome this additional idiocy and obstacle!

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

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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.

 

 

From: (redacted) [mailto:(redacted)]
Sent: Saturday, January 25, 2014 10:59 AM
To: Herbert Stein
Subject: Re: *RECALL MESSAGE: VNS Therapy...the egregious, immoral, unconscionable and discriminatory acts by private health insurance companies.

One day last week, the death of common sense came home to me in the local section of the Miami Herald - mandatory life sentences for 14-year-olds, a controversy over a school grade that was clearly an administrative error which they refused to correct, where released sex offenders can live (as contrasted to where they may go), and others of the same ilk.

Your latest diatribe smacks of this royally.

(redacted)

On Jan 22, 2014, at 12:12 PM, Herbert Stein wrote:

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, January 22, 2014 10:02 AM
To: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: *RECALL MESSAGE: VNS Therapy...the egregious, immoral, unconscionable and discriminatory acts by private health insurance companies.

Dear Jonathan,

*(The email information previously sent to you on Wed 1/22/2014 1:54 AM was sent in error.  Please properly dispose of that document.)

I have within these past two weeks received telephone calls from four (4) patients and/or their support persons referred to me for information and/or guidance in trying to obtain health insurance coverage from their private carriers for the replacement and care of their VNS devices.  All four patients have been denied medical coverage by their respective private insurance carriers for the replacement of their prosthesis.

I am once again returning to you and at the same time asking you and all the physicians and parties in my blind copy distribution of this message to help and suggest to me how we can jointly overcome the very serious and egregious problem(s) your agency had initially created for these patients.  While you and Ms. Amy Larrick have certainly done well by the Medicare/Medicaid patients requesting replacement of their depleted prosthesis, for which I am sincerely appreciative, you are apparently failing miserably by those who are covered by private health insurers.

Your agency’s decision of May 4, 2007 ineptly, ill advised, intentionally, stupidly or whatever you prefer to call it, overlooked grandfathering in the care for the volunteer study subjects and all those implanted patients prior to your national determination to not cover the depression patients.  Therefore medical coverage was denied this unique patient population with implanted medical devices through absolutely no fault of their own.  In turn, the private health insurers followed your lead and they too have denied health insurance coverage to this unique and seriously ill small population of patients.  Yet this exact same therapy, as you well know, is an approved treatment for Epilepsy patients paid for by both Medicare/Medicaid and the private health insurance carriers who also followed your early national determination to approve the therapy for the treatment of Epilepsy.

I am strongly led to believe that my fervent and sincere advocacy to correct this unconscionable and unjust situation was finally understood by you and your agency people as per my telephone conversation with Amy Larrick on Thursday, September 26, 2013.  You and your agency compassionately and sincerely attempted to rectify and correct this egregious oversight.  What I am now learning is that you have only partially succeeded.  The job is not done. The private health care insurance carriers are not following your informal decision to cover the medical needs of some of these patients or do they seem to be aware of your newest decision.  In that same conversation, in September, Amy made it clear to me your agency has no authority over the private health insurance carriers.  What you do have is the ability to get the message out whether formally or informal of the newer decision your department has rendered.  I requested Amy to please call Mr. Stephen Hemsley, CEO of United Healthcare to inform him of your more recent decision on behalf of one of their patient subscribers.  Amy advised me that in her discussion with you a decision was made not to call Mr. Hemsley.  How can these private insurers possibly follow your lead if they have no knowledge of your changes and/or decisions made informally or otherwise? 

I’m a retired executive of a multi-million dollar sales enterprise which often faced various challenges.  A meeting amongst partners was held often to discuss various issues.  Decisions were made quickly based upon available current information and decisions were rendered and executed.  Our decisions did not require lengthy or protracted deliberations.  Most often the decisions were correct and profitable.  As explained to you previously I’m unfamiliar with the bureaucracy and internal workings of government (your agency) or those of large health care carriers but I do know it is unacceptable and immoral the way these study subjects and patients are not being treated and cared for as well as and in my opinion discriminatory acts contrary to and against the intent of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

Again, I am not asking for a change of the May 4, 2007 national decision.  That onus and responsibility belongs to Cyberonics, the sponsor of the therapy.  I am requesting that which I originally set out to accomplish that all the VNS Therapy patients implanted for depression on or prior to the May 4, 2007 be rightfully covered for their medical needs no differently than the epilepsy patients.  I feel strongly it is incumbent and rightfully your agency’s responsibility to rectify this travesty and injustice and to not only inform the Medicare/Medicaid agencies within each state but the health insurance industry as a whole to bring them into similar compliance.

As I also explained to you previously from a unique statistical and financial standpoint; 100% of the VNS Therapy depression patients who have chosen to continue with their therapy are responders and obtaining efficacy long-term.  This is a statistic unheard of and truly amazing in the treatment of seriously ill depression patients.  It is also a statistic few if any number crunchers are aware of.  This equates to a benefit for both CMS and the private health insurance carrier who have been obviously too blinded in their bureaucratic fervor to understand the multiple yearly decrease and/or elimination of expenses for multiple hospitalizations, numerous doctor office visits, reduced or eliminated expensive psychotropic medications (as all demonstrated in Joyce’s case history) as well as expensive ECT therapy etc., etc. which in turn computes as a significant reduction and savings in patient costs while increasing profits on the part of the private insurer.

I have also attached to this email a letter of appeal to United Healthcare from a very compassionate and understanding physician on behalf of his patient which is more than self-explanatory.  It goes to the very heart of humanism contrary to the propensity of these various private health care organizations strict and sole focus on profits.

I am asking you to please reconsider and come up with some kind of plan or approach, whether formal or in formal, to make the private health insurance industry aware of your newer decision and determination in the hope that they too will amend their policy toward the existing VNS depression patients.  You cannot conscionably abandon these VNS Therapy depression patients simply because they are private insurance payers in their darkest of needs and not covered by Medicare/Medicaid.

Please let me know as soon as possible what you propose as there are currently four patients that I am aware of in desperate need of replacement surgery looking toward me and/or their attending physicians or support persons for further 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.

New era for migraine treatment as NICE backs TMS

New era for migraine treatment as NICE backs TMS

World News | January 22, 2014

Selina McKee

 

Six million migraine sufferers living in the UK have today been given a new treatment hope with National Institute for Health and Care Evidence (NICE) backing for a new magnetic pulse procedure.

Following a review of available evidence, which it notes remains limited, NICE’s Interventional Procedures Advisory Committee has concluded that Transcranial Magnetic Stimulation (TMS) - a non-invasive procedure designed to treat or prevent migraine episodes in people with acute or chronic migraine - is safe and effective.

The Institute has not, however, made any recommendations on funding for the procedure, effectively leaving that decision to local clinical commissioning groups, as its interventional procedures guidance only covers the safety of the procedure, whether it works well enough for routine use, and whether any special arrangements are needed for patient consent.

Along these lines, NICE has stressed that doctors should put “special arrangements” in place for clinical governance, patient consent and audit or research if they want to use TMS, which means that they should take "extra care to explain the risks to patients and put in place extra steps to record and review what happens," a spokesperson told PharmaTimes World News.

TMS is administered via a tabletop or handheld device that delivers a predetermined, variable level of magnetic pulse or pulses to the head.

Pain benefit

In one clinical trial data involving 164 patients, those treated for at least one attack of migraine with aura with a handheld sTMS device experienced significantly better pain-free rates two hours after the procedure than those receiving a 'sham' stimulation (39% versus 22%, respectively).

A significantly greater number of patients were also found to be pain-free (with no recurrence and no rescue drug use) at 24 hours (29% vs 16%, respectively) following treatment. 

And on the safety side, no device-related serious adverse events were reported in the trial, NICE noted.

Migraine affects around 10% of adults, but despite the availability of current treatments - such as painkillers, antiemetics, tritons, nerve blocks, Botox and acupuncture - there still remains a significant unmet need for patients.

According to The Migraine Trust, in Britain there are around190,000 migraine attacks every day and 25 million days lost from work or school each year, and it notes that the device may prove particularly appropriate for patients who find other treatments ineffective, or unsuitable, such as during pregnancy.

“This is a breakthrough treatment for those who cannot tolerate or do not respond to current treatment, and opens the door for a new era in treating migraine headaches," noted Consultant neurologist Fayyaz Ahmed, a trustee of The Migraine Trust.

Nevertheless, given the limited amount of long-term safety data available for the procedure, NICE has recognised the need for more research on magnetic stimulation of the brain to prevent and treat migraine.

Read more at: http://www.pharmatimes.com/Article/14-01-22/New_era_for_migraine_treatment_as_NICE_backs_TMS.aspx#ixzz2rIZG8JR9
Follow us: @PharmaTimes on Twitter

The battle for health care coverage continues…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, January 22, 2014 10:02 AM
To: Jonathan Blum, Deputy Administrator and Director for the Center of Medicare at the Centers for Medicare and Medicaid Services; Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid
Subject: *RECALL MESSAGE: VNS Therapy...the egregious, immoral, unconscionable and discriminatory acts by private health insurance companies.

Dear Jonathan,

*(The email information previously sent to you on Wed 1/22/2014 1:54 AM was sent in error.  Please properly dispose of that document.)

I have within these past two weeks received telephone calls from four (4) patients and/or their support persons referred to me for information and/or guidance in trying to obtain health insurance coverage from their private carriers for the replacement and care of their VNS devices.  All four patients have been denied medical coverage by their respective private insurance carriers for the replacement of their prosthesis.

I am once again returning to you and at the same time asking you and all the physicians and parties in my blind copy distribution of this message to help and suggest to me how we can jointly overcome the very serious and egregious problem(s) your agency had initially created for these patients.  While you and Ms. Amy Larrick have certainly done well by the Medicare/Medicaid patients requesting replacement of their depleted prosthesis, for which I am sincerely appreciative, you are apparently failing miserably by those who are covered by private health insurers.

Your agency’s decision of May 4, 2007 ineptly, ill advised, intentionally, stupidly or whatever you prefer to call it, overlooked grandfathering in the care for the volunteer study subjects and all those implanted patients prior to your national determination to not cover the depression patients.  Therefore medical coverage was denied this unique patient population with implanted medical devices through absolutely no fault of their own.  In turn, the private health insurers followed your lead and they too have denied health insurance coverage to this unique and seriously ill small population of patients.  Yet this exact same therapy, as you well know, is an approved treatment for Epilepsy patients paid for by both Medicare/Medicaid and the private health insurance carriers who also followed your early national determination to approve the therapy for the treatment of Epilepsy.

I am strongly led to believe that my fervent and sincere advocacy to correct this unconscionable and unjust situation was finally understood by you and your agency people as per my telephone conversation with Amy Larrick on Thursday, September 26, 2013.  You and your agency compassionately and sincerely attempted to rectify and correct this egregious oversight.  What I am now learning is that you have only partially succeeded.  The job is not done. The private health care insurance carriers are not following your informal decision to cover the medical needs of some of these patients or do they seem to be aware of your newest decision.  In that same conversation, in September, Amy made it clear to me your agency has no authority over the private health insurance carriers.  What you do have is the ability to get the message out whether formally or informal of the newer decision your department has rendered.  I requested Amy to please call Mr. Stephen Hemsley, CEO of United Healthcare to inform him of your more recent decision on behalf of one of their patient subscribers.  Amy advised me that in her discussion with you a decision was made not to call Mr. Hemsley.  How can these private insurers possibly follow your lead if they have no knowledge of your changes and/or decisions made informally or otherwise? 

I’m a retired executive of a multi-million dollar sales enterprise which often faced various challenges.  A meeting amongst partners was held often to discuss various issues.  Decisions were made quickly based upon available current information and decisions were rendered and executed.  Our decisions did not require lengthy or protracted deliberations.  Most often the decisions were correct and profitable.  As explained to you previously I’m unfamiliar with the bureaucracy and internal workings of government (your agency) or those of large health care carriers but I do know it is unacceptable and immoral the way these study subjects and patients are not being treated and cared for as well as and in my opinion discriminatory acts contrary to and against the intent of the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA).

Again, I am not asking for a change of the May 4, 2007 national decision.  That onus and responsibility belongs to Cyberonics, the sponsor of the therapy.  I am requesting that which I originally set out to accomplish that all the VNS Therapy patients implanted for depression on or prior to the May 4, 2007 be rightfully covered for their medical needs no differently than the epilepsy patients.  I feel strongly it is incumbent and rightfully your agency’s responsibility to rectify this travesty and injustice and to not only inform the Medicare/Medicaid agencies within each state but the health insurance industry as a whole to bring them into similar compliance.

As I also explained to you previously from a unique statistical and financial standpoint; 100% of the VNS Therapy depression patients who have chosen to continue with their therapy are responders and obtaining efficacy long-term.  This is a statistic unheard of and truly amazing in the treatment of seriously ill depression patients.  It is also a statistic few if any number crunchers are aware of.  This equates to a benefit for both CMS and the private health insurance carrier who have been obviously too blinded in their bureaucratic fervor to understand the multiple yearly decrease and/or elimination of expenses for multiple hospitalizations, numerous doctor office visits, reduced or eliminated expensive psychotropic medications (as all demonstrated in Joyce’s case history) as well as expensive ECT therapy etc., etc. which in turn computes as a significant reduction and savings in patient costs while increasing profits on the part of the private insurer.

I have also attached to this email a letter of appeal to United Healthcare from a very compassionate and understanding physician on behalf of his patient which is more than self-explanatory.  It goes to the very heart of humanism contrary to the propensity of these various private health care organizations strict and sole focus on profits.

I am asking you to please reconsider and come up with some kind of plan or approach, whether formal or in formal, to make the private health insurance industry aware of your newer decision and determination in the hope that they too will amend their policy toward the existing VNS depression patients.  You cannot conscionably abandon these VNS Therapy depression patients simply because they are private insurance payers in their darkest of needs and not covered by Medicare/Medicaid.

Please let me know as soon as possible what you propose as there are currently four patients that I am aware of in desperate need of replacement surgery looking toward me and/or their attending physicians or support persons for further 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.

It gives one something to sadly chuckle about.

I was just alerted by one of the VNS depression patients, still trying to obtain health insurance approval as a private subscriber for her replacement surgery, of this slide presentation from Cyberonics recent J.P. Morgan Conference of January 15, 2014.

It gives one something to sadly chuckle about. That is Cyberonics leading one to think that they are truly “Supporting appeals” for the depression patient.  In my opinion and based upon what I’ve recently learned from a couple of patients in a similar predicament, that is being insured by a private health insurance carrier but unable to get approval for replacement surgery despite CMS modified decision, Cyberonics appears to be anything but helpful.

Nutrition tip of the week: Are supplements a waste of money?

By Anita Marlay

January 18. 2014 1:00PM

Nutrition tip of the week: Are supplements a waste of money?

PHOTO/ Wikimedia photo

Supplements benefits can usually be met with food. Spinach, for example, is rich in iron and vitamins A, C, E and K.

Looking for a way to save money? Maybe it’s time to stop spending money on vitamin, mineral and herbal supplements. About 53 percent of American adults take some kind of supplement on a regular basis. This is an increase from 30 percent 20 years ago. Americans currently spend $30 billion a year on supplements.

Three new studies published in the Annals of Internal Medicine have failed to prove any benefit associated with taking supplements. They studied the effect of supplements on mortality, cardiovascular disease, cancer and cognitive decline, and found no difference in the groups who took the vitamin supplements and those that did not. The conclusion was that the general population who have no clear evidence of a deficiency do not benefit from vitamin supplementation.

Our bodies can use only so much vitamins and minerals. Once we’ve reached the limit, excess water-soluble vitamins are simply excreted in our urine. Excess fat-soluble vitamins get stored in our fat, and can become harmful to us. Too much beta-carotene has been linked to an increased risk of lung cancer in smokers. Too much vitamin E increases the risk of prostate cancer. Too much vitamin A can increase the risk of osteoporosis and hip fracture.

Vitamin supplements do not make up for a bad diet. They are not a substitute for food. Supplements simply cannot replicate all the nutrients and benefits that we get from food. Take an orange, for example. Not only are you getting vitamin C, but also beta-carotene, calcium, fiber, phytochemicals and antioxidants. A pill just can’t compete with that, no matter how much you pay for it.

People sometimes turn to herbal supplements as a means to avoid taking prescription drugs or to improve their health. Half of all Americans take herbal supplements, and it has become a $5 billion a year industry.

Most people believe that herbal supplements are safe to use because they are advertised as “natural” or “organic” and are legally sold and readily available. There are an estimated 50,000 adverse effects reported annually associated with the use of herbal supplements. Herbal supplements may contain unlabeled toxic or allergenic ingredients as part of their fillers. They may interact with prescription drugs you take.

Did you know that herbal supplement manufacturers are not regulated by any government agency? These supplements are not FDA approved and are not required to go through any testing for quality, truthfulness or accuracy in labeling. You can’t even be sure you are getting the dosage that the label says.

There are a few exceptions with supplement recommendations, namely folic acid for women of childbearing age. Calcium, vitamin D and B12 supplements commonly are recommended because it can be difficult to get adequate amounts of these solely from your diet.

Food is always the best source to meet all of our nutritional needs. Eating a balanced diet and including a variety of foods is ideal. Adding specific foods with high targeted nutrients can help if you think you may be lacking in certain vitamins. For example, spinach is rich in iron, potassium, vitamins A, C, E and K and magnesium. Sweet potatoes are an excellent source of vitamins A, B6, and C, fiber, potassium, and carotene. Salmon and tuna are rich in omega 3 fatty acids. Avocados are very rich in B vitamins, vitamins E and K, as well as healthy monounsaturated fats. Many common foods, like cereals, beverages and granola bars are now fortified with vitamins and minerals.

Here are some questions you should ask yourself if you still think you need to take vitamin supplements:

Do you eat fewer than two meals a day or consume fewer than 1,500 calories daily?

Is your diet restricted? Or, do you eliminate an entire food group, like meat or dairy?

Have you unintentionally lost more than 10 pounds in the past six months?

Do you have three or more alcoholic drinks daily?

Are you pregnant or trying to get pregnant?

Do you have a medical condition that affects how your body absorbs food? Examples might be chronic diarrhea, food allergies or intolerances, or diseases of the liver, gallbladder, intestines or pancreas.

If you can answer yes to any of these questions, you should ask your health provider discuss whether you need vitamin supplements.

Should you opt to take vitamin, mineral or herbal supplements, consider these factors.

Avoid mega doses. In general, do not exceed 100 percent of the recommended daily allowance, unless recommended by your health provider.

Check expiration dates. Dietary supplements lose potency throughout time, especially when stored in warm, humid environments like a bathroom. Discard any past the expiration date.

Ideally, take supplements with food and water. This ensures there is liquid to help dissolve the pill and fat to help absorb the vitamins.

Inform your doctor or pharmacist of all supplements you take if you are on any prescription medicines. Some supplements, especially herbal supplements, can interact dangerously with prescription drugs.

Read labels carefully to determine what dosage is recommended. Choose reputable brands with a seal of approval from ConsumerLab, NSF or United States Pharmacopeia.

Use caution with any herbal supplements. Remember that their claims have not been tested or proven, there is no regulation to ensure you are getting what is on the label, and there is a danger of adverse reactions.

Anita Marlay, R.D., L.D., is a dietitian in the cardiac rehab department at Lake Regional Health System in Osage Beach, Mo.

http://www.hannibal.net/article/20140118/LIFESTYLE/140119398/0/FRONTPAGE

Deep Brain Stimulation & Depression: A Decade of Progress with Helen S. Mayberg, M.D.

To the readership of this blog site:

The other day I sat in on a Brain & Behavior Research Foundation webinar presentation that I thought you might find of interest, if you have some time I’ve listed the link below.

Deep Brain Stimulation & Depression: A Decade of Progress with Helen S. Mayberg, M.D.

Sincerely,

Herb

UT Dallas study: Initial success for new tinnitus treatment

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Health

UT Dallas study: Initial success for new tinnitus treatment

by PressRelease • January 10, 2014 • 0 Comments

UT Dallas researchers have demonstrated that treating tinnitus, or ringing in the ears, using vagus nerve stimulation-tone therapy is safe and brought significant improvement to some of the participants in a small clinical trial.

Drs. Sven Vanneste and Michael Kilgard of the School of Behavioral and Brain Sciences used a new method pairing vagus nerve stimulation (VNS) with auditory tones to alleviate the symptoms of chronic tinnitus. Their results were published in the journal Neuromodulation: Technology at the Neural Interface.

VNS is an FDA-approved method for treating various illnesses, including depression and epilepsy. It involves sending a mild electric pulse through the vagus nerve, which relays information about the state of the body to the brain.

“The primary goal of the study was to evaluate safety of VNS-tone therapy in tinnitus patients,” Vanneste said. “VNS-tone therapy was expected to be safe because it requires less than 1 percent of the VNS approved by the FDA for the treatment of intractable epilepsy and depression. There were no significant adverse events in our study.”

According to Vanneste, more than 12 million Americans have tinnitus severe enough to seek medical attention, of which 2 million are so disabled that they cannot function normally. He said there has been no consistently effective treatment.

The study, which took place in Antwerp, Belgium, involved implanting 10 tinnitus sufferers with a stimulation electrode directly on the vagus nerve. They received two and a half hours of daily treatment for 20 days. The participants had lived with tinnitus for at least a year prior to participating in the study, and showed no benefit from previous audiological, drug or neuromodulation treatments. Electrical pulses were generated from an external device for this study, but future work could involve using implanted generators eliminating the need for clinical visits.

Half of the participants demonstrated large decreases in their tinnitus symptoms, with three of them showing a 44-percent reduction in the impact of tinnitus on their daily lives. Four people demonstrated clinically meaningful reductions in the perceived loudness of their tinnitus by 26 decibels.

Five participants, all of whom were on medications for other problems, did not show significant changes. However, the four participants who benefited from the therapy were not using any medications. The report attributes drug interactions as blocking the effects of the VNS-tone therapy.

“In all, four of the ten patients showed relevant decreases on tinnitus questionaires and audiological measures,” Vanneste said. “The observation that these improvements were stable for more than two months after the end of the one month therapy is encouraging.”

Researchers at the University Hospital Antwerp, Belgium, and MicroTransponder Inc. also contributed to the study.

A larger study involving four different centers will soon begin in the United States.

http://yottafire.com/2014/01/ut-dallas-study-initial-success-new-tinnitus-treatment/

Lead revision surgery for vagus nerve stimulation in epilepsy: Outcomes and efficacy.

Epilepsy Behav. 2014 Jan 2;31C:110-113. doi: 10.1016/j.yebeh.2013.12.002. [Epub ahead of print]

Lead revision surgery for vagus nerve stimulation in epilepsy: Outcomes and efficacy.

Waseem H¹, Raffa SJ², Benbadis SR³, Vale FL⁴.

Author information

• ¹Department of Neurosurgery and Brain Repair, Morsani College of Medicine, University of South Florida, 2 Tampa General Circle, USF Health, 7th Floor, Tampa, FL 33606, USA. Electronic address: hwaseem@health.usf.edu.
• ²Department of Neurosurgery and Brain Repair, Morsani College of Medicine, University of South Florida, 2 Tampa General Circle, USF Health, 7th Floor, Tampa, FL 33606, USA. Electronic address: sraffa@health.usf.edu.
• ³Department of Neurology, Morsani College of Medicine, University of South Florida, 2 Tampa General Circle, USF Health, 6th Floor, Tampa, FL 33606, USA. Electronic address: sbenbadi@health.usf.edu.
• ⁴Department of Neurosurgery and Brain Repair, Morsani College of Medicine, University of South Florida, 2 Tampa General Circle, USF Health, 7th Floor, Tampa, FL 33606, USA. Electronic address: fvale@health.usf.edu.

Abstract

We present, to our knowledge, the first published analysis of vagus nerve stimulation (VNS) lead revisions to incorporate quality of life, clinical response, and antiepileptic drug (AED) burden in postrevision clinical outcomes. Ten patients were followed and had no postoperative complications. Seven patients had improvement in quality of life, and three experienced no change. Eight patients noted a restoration of clinical response comparable with initial VNS implantation. Seven patients reported 30-60% improvement in seizure reduction, two experienced >60%, and one noted <30%. Six patients had no change in AED burden. Vagus nerve stimulation lead revision should be considered a safe option for patients with VNS lead failure and medically intractable epilepsy.

Copyright © 2013 Elsevier Inc. All rights reserved.

KEYWORDS:

AED, Epilepsy surgery, Intractable epilepsy, Lead revision, Seizure disorder, VNS, Vagus nerve stimulation, antiepileptic drug, vagus nerve stimulation

PMID:

24389021

[PubMed - as supplied by publisher]

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Lead revision surgery for vagus nerve stimulation in epilepsy: Outcomes and effi...

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  Epilepsy Behav. 2014 Jan 2;31C:110-113. doi: 10.1016/j.yebeh.2013.12.002. [Epub ahead of print]

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http://www.ncbi.nlm.nih.gov/pubmed/24389021

 

Magnets attract attention in fight against depression

Magnets attract attention in fight against depression

By Paul Sisson7:45 p.m.Jan. 4, 2014

Dr. Philip Botkiss demonstrates transcranial magnetic stimulation on Tamara Petersson of La Jolla using a therapy system made by Neuronetics, Inc. Alex Fuller

 

Dr. Philip Botkiss demonstrates transcranial magnetic stimulation on Tamara Petersson of La Jolla using a therapy system made by Neuronetics, Inc.

Tamara Petersson just celebrated her second Christmas without depression, a fact that sometimes seems impossible.

“To have a year of being depression-free, it’s a miracle,” she said.

Petersson is one of a growing number of patients turning to a new therapy that can reduce, or even eliminate, severe depression that has resisted traditional medication.

Called Transcranial Magnetic Stimulation, it targets a part of the brain behind the left side of a patient’s forehead called the prefrontal cortex. Studies have shown that depressed patients have less electric activity in this brain region than the average person.

“Those neurons are in hibernation. They’re just not functioning well, and what you’re doing is waking them up,” said Dr. Philip Botkiss, Petersson’s doctor.

Medical literature shows that magnetic stimulation is effective in patients who have seen no results after taking antidepressant medication. The U.S. Food and Drug Administration approved the treatment in 2008 after several double-blind studies showed that 70 to 75 percent of patients showed some improvement after undergoing stimulation, and other studies showed that 30 to 40 percent went into remission, meaning their depression was no longer detectable.

The procedure exposes the prefrontal cortex to a pulsing magnetic field delivered by a transmitter pressed to the left side of the forehead. The pulses induce an electrical current to move across the neurons, causing them to fire as they would in a patient who isn’t depressed.

Treatments last 37 minutes with four-second bursts of 40 pulses followed by 26 seconds of rest. The magnetic field is strong enough to make a staccato clicking sound and usually causes a patient’s face to twitch rapidly.

Petersson said the sensation of receiving the pulses is like a vibration. The sound is more pronounced.

“Some people are saying it feels like a woodpecker,” Petersson said.

Four to six weeks of therapy, administered five days a week, is necessary in order for patients to see results.

Petersson said she had struggled since 1986 with suicidal thoughts, lethargy and a perpetually gloomy mood.

For 7½ years, she said, she tried a different form of brain stimulation called electroconvulsive therapy, which passes an electric current through the brain and produces a seizure. But that technique never truly cleared away the depression. And electroconvulsion is a serious medical procedure requiring sedation and muscle relaxants.

“When you’re finished, you have to go into recovery until the anesthesia wears off. You have to have someone drive you home. It’s very invasive,” she said.

Dr. David Feifel, director of the neuropsychiatry and behavioral medicine program at UC San Diego, said these factors make the noninvasive nature of magnetic stimulation appealing for patients even though electroconvulsive therapy is still the standard of care.

“We have patients who come for treatment during their lunch break and go back to work. You couldn’t do that with ECT,” Feifel said.

Doctors also use another technique called deep brain stimulation to treat depression. That technique involves inserting electrical probes into the brain to deliver shocks to targeted areas. While inserting probes allows doctors to stimulate parts of the brain that cannot be reached with the current crop of magnetic stimulators, Feifel said that is changing.

“New machines that are just coming onto the market are able to go much deeper,” he said, adding that magnetism could soon be used to treat seizures and other brain conditions.

“I believe this is where brain medicine is going to be moving. I think the era of medication has probably reached its high-water mark, and this technology is probably going to become the standard,” Feifel said.

Today the treatment costs between $10,000 and $12,000. Several major health insurance companies, including Blue Cross, Blue Shield and Health Net, have started covering the procedure.

Petersson, 56, said her policy with Health Net covered her treatment in 2012. Before her depression diagnosis, she said she was a San Diego firefighter for 17 years. She said she hopes to go back to school and become a registered nurse.

http://www.utsandiego.com/news/2014/Jan/04/transcranial-magnetic-stimulation/2/?#article-copy