"I don’t understand…please explain it to me?" VNS Therapy for depression.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, May 20, 2015 5:01 AM
Subject: “I don’t understand…please explain it to me?” VNS Therapy for depression.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, May 20, 2015 4:53 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director; Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer
Subject: “I don’t understand…please explain it to me?” VNS Therapy for depression.

Dear Madam Secretary Burwell,

Obama Admin Makes Insurance Companies Obey HHS Mandate, Offer Abortion Drugs for Free

“I don’t understand…please explain it to me?”  Why is it that the President and Federal Government can mandate and tell the health insurers they “must” follow suit and offer abortion drugs for free and yet you and your CMS agency, for the two (2) years I’ve been writing to your predecessor and you advocating for the VNS Therapy depression patients, can’t tell all your Medicare contractors in writing to rightfully cover the care once and for all for these study subjects and patients?

While we’re on the subject of “must” how is it that the Government can tell the private health insurers what they must do when CMS tells me they have no control over private health insurers when it comes to the care of these very same VNS Therapy patients?

I constantly stand in wonderment how anything in our convoluted and bloated government bureaucracy ever gets accomplished.

Once again, please read the slogans listed below taken from your own home pages.  Is there not anyone with authority and common sense within your agencies to notify all CMS contractors and private health insurance carriers of the doctrine of “Continuity of care” and the fact this doctrine was reaffirmed for these patients in your agency’s December 30, 2014 decision?

Just what does it take to get through to you people to take effective action?

clip_image001

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, May 11, 2015 2:14 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director; Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer; Courtney Turner; Nancy Conn – DMOA Acting Deputy Director
Subject: Medicare/Medicaid coverage for VNS Therapy depression patients implanted prior to May 4, 2007.

Dear Madam Secretary Burwell,

clip_image001

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

So exactly when does your agency/bureaucracy actually do something helpful and effective “for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves”?

It has been two (2) years now that I’ve been on this project advocating and writing to former Secretary Kathleen Sebelius and you.  My original pleas were for “Compassionate Use” only to learn all along your CMS agency incorporates the doctrine of “Continuity of care” which rightfully should have insured medical coverage for this unique population of patients implanted with a medical device being denied care and/or replacement by your various contractors. 

The decision of December 30, 2014 reiterates this fact of “Continuity of care”.

What does it take to get any of you people to understand that it is rightfully your responsibility to care for these patients (read you’re agencies statement at the beginning of this communication) and you folks are failing?  Why can’t you add an addendum to the NCD of May 4, 2007 noting the fact that all VNS Therapy depression patients implanted prior to that date are rightfully to be covered?  Why can’t any formal message, document or piece of paper be sent to all your Medicare/Medicaid contractors to inform them what should have properly been included in the original decision but was egregiously or negligently and/or intentionally overlooked and/or omitted?

Why can’t anyone in the multitude of your agencies personnel get the message out to all your contractors?  Why must the patient, “least able to help themselves” be forced to appeal? 

“Please note, that if a particular Medicare claim is not paid, the Medicare beneficiary has the right to appeal.” — Dr. Patrick Conway, CMS Chief Medical Officer.

Why it is your own people don’t understand the true realities of life/procedures from the patient viewpoint?  The hospitals will not proceed unless they get the okay from MAC.  The hospitals will not perform surgery for replacement of the prosthesis for a depression patient although they will perform the exact same surgery for an epilepsy patient.  Obviously your own people don’t know it is not a question of appealing non-payment but first obtaining approval for the surgery and/or care in the first place.

It is truly, truly sad and maddening situation as I sit here writing to you for the umpteenth time to tell you, in my opinion, of the ineptness and what I consider the incredible incompetence within your agency based upon some of the answers and/or communications that I receive based upon patient pleas asking for my assistance to overcome your contractor’s denials.

Why can’t you in writing or one of your subordinates inform all your Medicare/Medicaid contractors in one document submission that these VNS Therapy depression patients are to be covered and treated exactly the same as the VNS Therapy epilepsy patient?  Is that too difficult for anyone to comprehend?

I no longer have to beg for “Compassionate use”.  I now ask that you only do what are rightfully your job and that of all your subordinates and that which has been adjudicated within your own agency. 

Medicare/Medicaid coverage is rightfully to be covered for all VNS Therapy depression patients implanted prior to May 4, 2007.

The next letter I would truly hope to receive from either you or any of your subordinates is one informing me that all the Medicare/Medicaid contractors have rightfully been informed and acknowledge that all VNS Therapy depression patients implanted prior to May 4, 2007 are to be covered for both care and replacement of their medical devices without any further need or discussion for any appeals.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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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.

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UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke

UT Southwestern Among Sites to Test Implant Device’s Ability to Restore Arm Function Post-Stroke

Published on May 8, 2015

ut

A recent university news release from UT Southwestern Medical Center reports that the center will be one of three national sites to pioneer US testing for an implant device designed to stimulate the vagus nerve in stroke patients; the aim is to determine whether the technology can help restore lost arm function.

The release states that the device, known as the Vivistim System, was developed by Dallas-based company MicroTransponder Inc with a license from UT Dallas. The technology is engineered to stimulate the neck’s vagus nerve. It is implanted under the collarbone and is about the size of a pacemaker. According to the release, it sends painless, half-second electrical pulses up the vagus nerve, causing neruomodulators to be released in various parts of the brain. There are also alternate forms of vagus nerve stimulation therapy already approved for use by the FDA for treating other illnesses, such as depression and epilepsy, the release adds.

The neuromodulators “appear to facilitate the creation of new neuron pathways in the brain, which play a key role in restoring muscle movement,” says Ty Shang, MD, PhD, in the release.

Shang is an assistant professor of Neurology and Neurotherapeutics, UT Southwestern, and is heading the UT Southwestern arm of the trial.

A stroke deprives brain cells of oxygen, and without oxygen, brain cells die and can no longer perform the function for which they were intended, Shang points out.

“There has been no known way to regenerate new brain cells to replace them, but in early tests with this device, the brain appears to ‘rewire’ other cells to perform the function,” he adds.

The Vivistim System is built to improve motor function in the more involved arm of a patient post-stroke. The technology was studied beginning in 2013 for efficacy and safety in a small study in Glasgow, Scotland, the release says. Individuals in the Glasgow study reportedly experienced meaningful, functional improvements in their more involved arm.

Shang theorizes that VNS therapy may serve as the stimulus for motor relearning with the more involved arm for individuals post-stroke. While gaining functional improvement in the impaired arm can be a challenge, Shang says, “VNS therapy might make achieving functional gains easier.”

The release notes that currently, UT Southwestern researchers are seeking individuals in the Dallas-Fort Worth metroplex who sustained a stroke 4 months to 5 years ago to participate in the trial.

Once participants have undergone outpatient surgery to implant the device, the release says they will be scheduled for 18, 90-minute sessions of intensive, task-specific therapy during a 6-week period, with quarterly follow-up evaluations for the next year.

Interested participants can visit www.vnsstroketrial.com or contact the Department of Physical Therapy at (214) 648-1533.

[Photo Credit: UT Southwestern Medical Center]

[Source(s): Newswise, UT Southwestern Medical Center]

http://www.ptproductsonline.com/2015/05/ut-southwestern-one-sites-test-implant-device-designed-restore-arm-function-post-stroke/#sthash.flR5WI14.dpuf

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VNS Therapy for Depression – "to hang on their individual desks and walls so that they finally get the message"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, April 24, 2015 2:56 AM
To: Dr. Patrick Conway – Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer
Cc: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director
Subject: VNS Therapy for Depression – “to hang on their individual desks and walls so that they finally get the message”

Dear Dr. Conway,

On the Internet about page of HHS.gov you’ll find the following quotations:

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First, thank you for taking your valuable time to respond to my recent email to Madam Secretary Sylvia Burwell.  For purposes of this response I shall not at the moment address “Medicare has no jurisdiction over coverage decisions of a private insurance company.”  What I would like to address is that I have been cited and admonished in my two (2) years of advocacy and correspondence for this unique VNS Therapy depression patient population for my sometime harsh rhetoric in addressing/responding to those who work for the bureaucracy of HHS/CMS.  I therefore wish to point out that which follows may be harsh and is not a personal indictment of you.

I have spent two (2) years advocating and battling with HHS/CMS only to find out that your own agency acknowledges the doctrine of “Continuity of care” and these patients should have rightfully been attended to and cared for from the onset.  And yet, there are still obstacles being thrown in our way as evidenced by your letter whether through lack of knowledge, incompetence or bureaucratic sludge.

Please read those quotations listed above real carefully once again and then tell me the contents of your letter to me adhere to those principles.  My father-in-law, may he rest in peace, used to use spoonerisms at times to raise attention and/or get his point across.  One such spoonerism is the fact that you’ve got this matter “backasswards”.  I’m well aware of NCD of May 4, 2007, which incidentally only applies to depression patients, but you totally omit addressing your own agencies recent decision of December 30, 2014 and the doctrine of “Continuity of case as I quote:

VII. The AGGRIEVED PARTIES’ CONTENTIONS REGARDING MEDICARE BENEFITS WHO WERE IMPLANTED WITH THE VNS DEVICE PRIOR TO MAY 4, 2007 PROVIDE NO BASIS FOR INVALIDATING NCD 160.18(C).

The Aggrieved Parties suggest that NCD 160.18(C) is invalid because it does not address the needs of Medicare beneficiaries with TRD who were implanted with the VNS device and received Medicare coverage for VNS prior to the issuance of NCD 160.18(C) on May 4, 2007. Statement ¶¶ 38-43; Complaint ¶¶ 90-95. With respect to those beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for: (1) “the interrogation and calibration of a VNS therapy device implanted and deemed to be reasonable and medically necessary when implanted for TRD”; or (2) “for the replacement of the implanted pulse generator device upon battery expiration, when required[.]” AP Statement ¶ 43. According to the Aggrieved Parties, those omissions conflict with: (1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).

Why any of these seriously ill depression patients must be challenged by your bureaucracy to have to file an appeal is anything but effective management in my opinion or in line with “Continuity of care” as cited in the above quotation from the December 30, 2014 decision.  Is there no one in all of your agencies with the authority or capability to issue a formal document of notification to any and all of your “local Medicare Administrative Contractors” to hang on their individual desks and walls so that they finally get the message?  These patients are to be covered by Medicare/Medicaid period.

With all due respect to you and the fact I’ve been a mental health advocate/activist and support person over a half century, your letter to me is one which I refer to as “bureaucratic speak”.  It sounds good but effectively accomplishes nothing.  How’s about also getting the message out to MAC (Medicare Appeals Council)?  So when the hospital applies for patient coverage for replacement surgery MAC can expeditiously approve the request because they would already have the “Continuity of care” decision of December 30, 2014 to guide them thereby significantly lessening the stress and anxiety on an already ill patient in line with the precepts noted early on in this message?  How’s about finally producing some effective and productive document to put these issues to bed?

The former Deputy Administrator Director, Jonathan Blum, put in place a contact individual within your organization to expedite and lessen the stress on the patient in order to obtain their replacement prosthesis.  In view of the fact that CMS acknowledges the doctrine of “Continuity of care” and the rightful medical coverage for these patients why is it seemingly so difficult to get the damn message out to your bureaucracy and get them all on the same page at the same time?  Send me a new letter telling me these issues have been resolved and then I can feel you and your agency have finally accomplished something and become effective.  Until that time I’ll consider these various replies as the normal “bureaucratic speak” that comes from DC.

Once again, thank you for taking the time to respond to my advocacy for the VNS Depression patients.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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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.

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Device-based autonomic modulation in arrhythmia patients: the role of vagal nerve stimulation.

Device-based autonomic modulation in arrhythmia patients: the role of vagal nerve stimulation.

Huang WA1, Shivkumar K, Vaseghi M.

Author information
  • 1UCLA Cardiac Arrhythmia Center, University of California, 100 Medical Plaza, Suite 660, Los Angeles, CA, 90095, USA.
Abstract
OPINION STATEMENT:

Vagal nerve stimulation (VNS) has shown promise as an adjunctive therapy for management of cardiac arrhythmias by targeting the cardiac parasympathetic nervous system. VNS has been evaluated in the setting of ischemia-driven ventricular arrhythmias and atrial arrhythmias, as well as a treatment option for heart failure. As better understanding of the complexities of the cardiac autonomic nervous system is obtained, vagal nerve stimulation will likely become a powerful tool in the current cardiovascular therapeutic armamentarium.

PMID:
25894588
[PubMed]

http://www.ncbi.nlm.nih.gov/pubmed/25894588

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Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.

J Neurosurg. 2015 Mar;122(3):532-5. doi: 10.3171/2014.10.JNS14640. Epub 2014 Dec 19.

Relationship of vocal cord paralysis to the coil diameter of vagus nerve stimulator leads.

Robinson LC1, Winston KR.

Author information
  • 1Department of Neurosurgery, University of Colorado School of Medicine, Aurora;
Abstract
OBJECT:

This investigation was done to examine, following implantation of vagus nerve stimulators, the relationship of vocal cord paralysis to the inner diameter of the coils used to attach the stimulator lead to the nerve.

METHODS:

All data in this investigation were collected, as mandated by the FDA, by the manufacturer of vagus nerve stimulators and were made available without restrictions for analysis by the authors. The data reflect all initial device implantations in the United States for the period from 1997 through 2012.

RESULTS:

Vocal cord paralysis was reported in 193 of 51,882 implantations. In patients aged 18 years and older, the incidence of paralysis was 0.26% when the stimulator leads had coil diameters of 3 mm and 0.51% when the leads had 2-mm-diameter coils (p < 0.05). Across all age groups, the incidence of vocal cord paralysis increased with age at implantation for leads having 2-mm-diameter coils.

CONCLUSIONS:

In patients aged 18 years and older, vocal cord paralysis occurred at almost twice the rate with the implantation of vagus nerve stimulator leads having 2-mm-diameter coils than with leads having 3-mm-diameter coils. The incidence of vocal cord paralysis increases with patient age at implantation.

KEYWORDS:

VNS = vagus nerve stimulation; complications; epilepsy; vagus nerve injury; vagus nerve stimulator lead; vocal cord paralysis

PMID:
25526267
[PubMed – indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/25526267

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VNS Therapy for Depression – Another taste of governmental bureaucracy and its ineptitude…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, April 21, 2015 11:02 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS – Deputy Administrator & Director; Courtney Turner; Davonda Roberts – Nurse Consultant, HHS/CMS
Subject: VNS Therapy for Depression – Another taste of governmental bureaucracy and its ineptitude…

Dear Madam Secretary Burwell et al,

This early morning I received a lovely and caring telephone call from Ms. Davonda Roberts, Nurse Consultant out of your Atlanta, Ga Medicare office following up on an email I sent you and others on January 8, 2015.  I expressed my appreciation for her telephone call and for seeking to assist me this morning.  The fact is and the reality is someone in the executive offices of HHS/CMS in the Washington DC bureaucracy took my email message and simply shoved the message on down the line to this lovely woman who had no idea of my struggles and advocacy these past two years or the events surrounding the VNS Therapy for Depression and the issues.

A simple analysis from my viewpoint after some two (2) years of advocacy to obtain medical coverage for VNS Depression Patients implanted prior to the CMS determination of May 4, 2007 is that our health care bureaucracy is so voluminous that literally “One hand does not know what the other hand is doing” and that no one and I do mean no one is really knowledgeable how to promptly and effectively assist our citizen patients.

Almost two (2) years into this struggle I learn about the doctrine of “Continuity of Care.” Yet no one but no one in all of HHS/CMS acknowledged or cited the doctrine of “Continuity of Care” to insure the medical coverage for these patients.  I have appealed to you and your predecessor Kathleen Sebelius numerous times for “Compassionate Use” of this therapy for these patients when all this time the doctrine of “Continuity of Care” existed in your records which should have promptly insured coverage and care for these patients.

I am truly embarrassed for you and for all the agencies you direct.

Worse yet is the fact I received another communication recently from a woman having Medicare coverage and difficulty obtaining replacement surgery for her depleted device.  She called Courtney Turner without receiving a return call.

Doesn’t anyone within the bureaucracy comprehend the urgency of these health care matters?

Lastly, I am also truly flabbergasted by the fact that another individual also contacted me that he was covered by Florida Blue, a private health insurance carrier. and they too have continued to deny him replacement therapy.  I realize and have heard it numerous times that CMS has no control over private health insurance companies.  What about “Continuity of Care”?  Is there not anyone in all of the HHS bureaucracy with enough authority, intelligence and moxie to call Patrick J. Geraghty, CEO of Blue Cross and Blue Shield of Florida (Florida Blue) to inform him of “Continuity of Care” to assist this patient in rightfully obtaining replacement prosthesis?

How much longer do these ineptitude, immoral and egregious acts have to continue?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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NOTICE OF CONFIDENTIALITY / Disclaimer

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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.

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