VNS Therapy (Vagus Nerve Stimulation)

Joyce, my spouse was one of the earliest study subjects for VNS Therapy for Depression (December 13, 1999). I am her long time support person and health care advocate/activist of 5 decades. The intent of the blog is not to promote any therapy, product or treatment but to continue sharing our experiences and knowledge as it relates to VNS. I endorse patient education in collaboration with a caring, knowledgeable and licensed health care professional while also encouraging hope and persistence.

Wednesday, May 20, 2015

"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?

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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Monday, May 11, 2015

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,

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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Saturday, May 9, 2015

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

Published on May 8, 2015

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