VNS Therapy (Vagus Nerve Stimulation)

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NOTICE OF CONFIDENTIALITY / Disclaimer

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From: Julie Ottaviani [mailto:julieottaviani@aim.com]
Sent: Friday, August 21, 2015 6:59 AM
To: fabrik@bellsouth.net
Subject: Re: VNS Therapy for Depression - Implementation and Enforcement of the Law.

Dear Herb and Joyce,

I just wanted to let you know how much I appreciate all that you are doing for our cause. I am doing very well health wise and hope the same is true for you both. Herb, your tireless efforts do not go unnoticed. I read each and every email you send and save them to a file. I hope Madam Secretary Burwell does the same and more. It is unfortunate that the pace of our leaders in Government Health as well as most areas is slow and slower. But we are strong and VNS has made us so. We stand with you in this fight and we will be persistent

Keep the Faith

Julie Ottaviani

You may use this email in any way you deem useful..

Julie Ottaviani
julieottaviani@aim.com

-----Original Message-----
From: Herbert Stein <fabrik@bellsouth.net>
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services <sylvia.burwell@hhs.gov>
Cc: President of the United States <president@whitehouse.gov>
Sent: Thu, Aug 20, 2015 5:51 pm
Subject: VNS Therapy for Depression - Implementation and Enforcement of the Law.

Dear Madam Secretary Burwell,

I’m terribly sorry to have to once again bore you with the fact that either you and/or your subordinates are not carrying out the duties, obligations and/or law with which you are entrusted.

December 30, 2014 an appeal was adjudicated rendering the NCD of May 4, 2007 not applicable to all the patients implanted prior to May 4, 2007. Depression patients with Vagus Nerve Stimulators, a medical device implant, are rightfully entitled, Doctrine of Continuity of Care, to medical care and replacement when necessary without having to be denied and/or responsible to appeal any denials.

The issue I now bring to your attention is the “implementation” and “enforcement” of the law and apparent lack of distribution of this law and acknowledgement by MAC, Regional agencies, State agencies, contractors etc. under your authority as evidenced by the communications I’ve received from various members of your staff and agencies that I have already shared with you and others.

The individual, with whom I chatted with today, a member of your agencies, confirmed “the left hand not knowing what the right hand is doing.”

I would finally and once and for all appreciate your getting your agencies on the same page. I would also appreciate a communication from your office that all agencies, contractors etc. on down the line acknowledge and will implement and enforce the law.

As always, I wish all those reading my missives good health and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

Thursday, August 20, 2015

VNS Therapy for Depression - Implementation and Enforcement of the Law.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 20, 2015 5:51 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Cc: President of the United States
Subject: VNS Therapy for Depression - Implementation and Enforcement of the Law.

Dear Madam Secretary Burwell,

I’m terribly sorry to have to once again bore you with the fact that either you and/or your subordinates are not carrying out the duties, obligations and/or law with which you are entrusted.

The individual, with whom I chatted with today, a member of your agencies, confirmed “the left hand not knowing what the right hand is doing.”

As always, I wish all those reading my missives good health and all the good you’d wish for yourselves.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

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

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NOTICE OF CONFIDENTIALITY / Disclaimer

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test document 08/20/2015 7:55 PM

test document

Monday, August 10, 2015

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

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

Dear Ms. Perry,

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

In your letter you stated:

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

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

Receive that treatment, please visit:

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

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

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

[Proposed Rules]

[Pages 40835-40890]

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

[FR Doc No: 2013-16107]

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

Department of Health and Human Services

DEPARTMENTAL APPEALS BOARD

Appellate Division

NCD 160.18, Vagus Nerve Stimulation

Docket No. A-14-3

Decision No. 2613

December 30, 2014

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

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

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

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

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

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733