VNS Therapy (Vagus Nerve Stimulation)

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NOTICE OF CONFIDENTIALITY / Disclaimer

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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

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

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Monday, January 12, 2015

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.

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

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Thursday, January 8, 2015

"...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 08, 2015 3:36 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director
Subject: "...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007."

Dear Madam Secretary Burwell et al,

I would first like to wish you and yours and all those reading this message a very Happy, Healthy, Peaceful and Prosperous New Year and with that said it is back to business.

That is back to the business of VNS Therapy for Depression and what I consider the continuing ineptitude and oversight of our various government agencies as it relates to the study subjects and patients implanted with a beneficial medical device seeking care and replacement for those who were implanted prior to the National Coverage Determination (NCD) of May 4, 2007.

We now have another government agency Departmental Appeals Board (DAB) of the Department of Health and Human Services rendering a decision partially favorable to the Medicare/Medicaid insured but completely ignoring and/or overlooking a group of patients who are covered by private health insurance carriers who were also implanted prior to the National Coverage Determination (NCD) of May 4, 2007.

Don’t any of you folks really look into or think about the whole picture and the ramifications of your actions? The private health insurance carriers such as United Healthcare jumped on the bandwagon of denying coverage to patients implanted prior to May 4, 2007 while also calling the therapy “experimental”. The fact is for this unique population of patients wanting to continue their therapy it is no longer experimental but it is in fact a multi-year tried, true, beneficial and lifesaving therapy for some.

I do thank the Departmental Appeals Board for some judgmental common sense and logic in understanding there are study subjects and patients greatly benefiting from VNS Therapy for Depression as is my spouse Joyce and for finally acknowledging somewhere in writing (I have yet to read the official decision and document) that my spouse and others covered by Medicare/Medicaid could now be assured of their continued medical coverage for this therapy. But as I intimated previously, just what does it take to convince you folks to also care for those with private insurance? They too have been medically, immorally and irresponsibly left to their own means to find care through the negligence of your various agencies.

I simply am not knowledgeable of the inner workings of your bureaucracy and how anything gets done. I do know “A federal judge ordered Health and Human Services Secretary Kathleen Sebelius to allow a 10-year-old girl to receive a lung transplant sooner than required.” Your predecessor Kathleen Sebelius quickly issued a “Compassionate Use” document to insure the judge’s order was complied with.

Why aren’t you doing the same to insure all the VNS Therapy for Depression patients implanted prior to May 4, 2007 are similarly covered for their care and replacement?

It would only take a moment of your time to insure all these study subjects and patients are rightly cared for. Can’t you finally right the wrong and injustice perpetrated against this group and set them all back on the track to wellness?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733