Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Sunday, January 25, 2015

RE: Response to Your January 12, 2015 Email

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, January 25, 2015 6:33 PM
To: 'Turner, Courtney (CMS/OHI)'
Cc: 'Burwell, Sylvia M. (HHS/OS)'; 'Cavanaugh, Sean (CMS/CM)'
Subject: RE: Response to Your January 12, 2015 Email

Dear Courtney,

Thank you as always for responding to my communications.  I am tardy in reply to you as we were away cruising and just returned home today.

I have been carefully following the DAB website for any announcement relating to their recent decision on VNS Therapy for Depression.  I was just trying to touch all bases in the event I may have missed and/or overlooked any issuance of a formal document.

I am, as you know, also very disappointed in that once again any wording that I’ve read so far does not encompass all the patients implanted prior to May 4, 2007.  What I’ve read appears to leave out the patients that were previously covered by private insurers (i.e. United Healthcare) who wish to continue with the therapy and that again are a moral and unconscionable oversight on the part of DAB and our voluminous government agencies.  It is as if our government bureaucracy can’t get anything right on the first go-round or the second for that matter.

As always, I wish to thank you for your outstanding efforts and help on behalf of Joyce and the other VNS patients formerly suffering Major Depressive Disorder who have been able to obtain replacement devices and care so that they may continue enjoying lives either free of depression or greatly improved mental state.

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.

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

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.

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. 

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

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

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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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.

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

vnsdepression@gmail.com

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

http://www.vnstherapy.wordpress.com

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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: Burwell, Sylvia M. (HHS/OS) [mailto:Sylvia.Burwell@hhs.gov]
Sent: Thursday, January 08, 2015 3:37 PM
To: Herbert Stein
Subject: RE: "...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007. "

Thank you very much for your e-mail.  Our ability to deliver impact depends on your input.  I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review. 

This Department belongs to the American people, and what you have to say matters to all of us.   As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose sight of the fact that ultimately, you are “the boss” – and everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

Thank you again for your message.

Sylvia Burwell

Secretary

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

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

HOUSTON, Jan. 5, 2015 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services.

The decision concludes that the record regarding the VNS Therapy System for treatment-resistant depression is complete and adequate to support the 2007 National Coverage Determination (NCD).  The Centers for Medicare & Medicaid Services (CMS) concluded in the 2007 NCD that coverage for the treatment-resistant depression indication is not reasonable and necessary.  The decision also clarifies that CMS and its contractors will allow coverage of maintenance services – including replacement of the implanted VNS Therapy device upon battery expiration – for beneficiaries who began receiving VNS Therapy prior to May 4, 2007.

"While we acknowledge the importance of clarity for beneficiaries already benefiting from VNS Therapy, we are disappointed with this decision and disagree with the position taken by CMS.  We believe that the total body of evidence presents a compelling rationale for access to the VNS Therapy System in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics' President and Chief Executive Officer.  "The company is evaluating options for challenging the DAB decision."

About Cyberonics, Inc. and the VNS Therapy System

Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation.  The company develops and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Safe harbor statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words.  Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable.  We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable.  Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning a challenge to the DAB decision and CMS reimbursement for the treatment-resistant depression indication.  Important factors that may cause actual results to differ include, but are not limited to:  continued market acceptance of the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC).  For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 25, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.

Additional information about Cyberonics and the VNS Therapy System is available at www.cyberonics.com

Contact information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332
ir@cyberonics.com

SOURCE Cyberonics, Inc.

http://www.prnewswire.com/news-releases/cyberonics-provides-update-on-departmental-appeals-board-decision-regarding-coverage-of-vns-therapy-system-in-treatment-resistant-depression-300015832.html

Departmental Appeals Board (DAB)

Legal images collage

The title Departmental Appeals Board (“DAB”) refers both to the Board Members (collectively the “Board”) that the Secretary appoints and to the larger staff organization. The DAB provides impartial, independent review of disputed decisions in a wide range of Department programs under more than 60 statutory provisions.

The DAB includes the Board itself (supported by the Appellate Division), Administrative Law Judges (“ALJs”) (supported by the Civil Remedies Division), and the Medicare Appeals Council (supported by the Medicare Operations Division). Thus, the DAB has three adjudicatory divisions, each with its own set of judges and staff, as well as its own areas of jurisdiction. The DAB also has a leadership role in implementing Alternative Dispute Resolution (“ADR”) across the Department, since the DAB Chair is the designated Dispute Resolution Specialist under the Administrative Dispute Resolution Act of 1996.

DAB Divisions

Alternative Dispute Resolution Division
The Alternative Dispute Resolution Division provides alternative dispute resolution (“ADR”) services in appeals filed with the Board’s other three Divisions. ADR in Board cases typically involves either mediation or ombudsman services.

Appellate Division
The Appellate Division provides staff support for the Board Members, who are career civil servants appointed by the Secretary to provide an impartial, independent review of disputes arising in a wide range of HHS programs. The Board also provides appellate review of certain types of Administrative Law Judge decisions. In most cases, the Board decision is the final administrative decision of HHS.

Civil Remedies Division
The Civil Remedies Division (“CRD”) provides staff support for the Administrative Law Judges (“ALJs”) assigned to the DAB. The ALJs are qualified under the Federal Administrative Procedure Act to conduct hearings on the record. Generally, the ALJ decision is an initial decision that may be appealed to the Board. If the ALJ decision is not appealed, it represents the final administrative decision.

Medicare Operations Division
The Medicare Operations Division provides staff support to the Administrative Appeals Judges and Appeals Officers on the Medicare Appeals Council. The Council provides the final administrative review of claims for entitlement to Medicare and individual claims for Medicare coverage and payment filed by beneficiaries or health care providers/suppliers.

http://www.hhs.gov/dab/

Saturday, December 20, 2014

Transcranial Magnetic Stimulation: What Is It and Who Needs It?

Transcranial Magnetic Stimulation: What Is It and Who Needs It?

TMS uses magnetic pulses to electrically stimulate nerve cells in the brain and relieve symptoms of depression.

A silhouetted sad person is pictured.

Though TMS can help to lessen the symptoms of depression, not all patients respond to the treatment.

By Kirstin Fawcett Dec. 15, 2014 | 11:58 a.m. EST + More

 

By the time she was 61, Martha Rhodes had spent decades battling intractable depression. Diagnosis: treatment-resistant major depressive disorder. She’d tried a variety of medications to no avail; most were ineffective or caused nausea, diarrhea, weight gain and mood swings. During one particularly low evening in 2009, she attempted suicide. And every morning when she awoke, she experienced what she describes as “an emotional nausea – it was like this feeling of, ‘Why am I still here? Why do I have to be alive?’” 

But four years ago, Rhodes, now 65, of Danbury, Connecticut, underwent a procedure she says saved her life: repetitive transcranial magnetic stimulation, which uses magnetic pulses to electrically stimulate nerve cells in the brain and is used by doctors to relieve symptoms of depression

“My feelings of hopelessness, wishing I were dead and that life wasn’t worth living – all of that went away,” recalls Rhodes, who chronicled her experience with TMS in her 2013 book “3,000 Pulses Later.” Rhodes says she shares her story with others to demystify the treatment – which is often misunderstood by both patients and doctors, though it's increasingly used by medical practitioners nationwide.

What Is TMS?

TMS was first developed in the early 1980s, but it was only approved by the Food and Drug Administration in 2008 for patients like Rhodes, who’ve unsuccessfully tried one or more medications for their treatment-resistant depression and want to explore other options. That's according to Mark George, a professor at the Medical University of South Carolina in Charleston.

Depression, George says, is a disease that stems from a lack of activity in certain parts of the brain – specifically the prefrontal cortex, the region  right above the eyes that helps regulate emotions. TMS is a technology that allows doctors to noninvasively stimulate that part of the brain and “exercise it back into health.” 

During TMS, George says, a doctor takes a hand-held electromagnetic coil and holds it up to the front left side of the patient’s skull for nearly 40 minutes. The electricity creates a powerful magnetic field, which passes into the brain and causes neurons to fire electrical impulses. In turn, the electrical impulses encourage a chemical reaction that, over time, helps lift mood.

TMS is different from other brain-stimulation therapies, like electroconvulsive therapy. During ECT, patients receive anesthesia and are stimulated across the scalp with a very small electrical current. The current induces a short brain seizure, which produces changes in the brain’s functioning and chemistry. TMS, on the other hand, is a nonconvulsive procedure; patients don’t have a seizure, and they are awake and alert the entire time. There are also no cognitive side effects or memory loss in TMS, which physicians say are common – although benign – in patients who undergo ECT. 

“But in some ways, the two procedures are similar,” George says. “We're trying to reset and wake up connections in the brain that aren't really working well.” 

What Is It Like?

Five days a week, Rhodes, a former advertising executive, traveled to Hartford Hospital’s Institute of Living in Hartford, Connecticut, where she sat in a comfortable reclining chair with a magnetic coil affixed to the side of her head delivering 3,000 pulses to her prefrontal cortex. She was able to watch TV, read, receive visitors and relax. After the day’s procedure was finished, she drove herself home. This lasted six weeks, with a total of 30 sessions – a standard duration, doctors say, for a course of TMS. (Some patients decide to get TMS for shorter or longer periods – say, four or seven weeks – depending on their needs.)

Rhodes compared the sensation of having electrical pulses delivered to the side of her head in the form of four, 10-pulse bursts in a row (with a rest period of 26 seconds between each interval) to a woodpecker pecking her skull. She also had to wear earplugs to drown out the noise of the machine, which makes a loud tapping sound.

The treatment was “jarring” at first, but eventually Rhodes got used to it. Then about four weeks in, after her 19th or 20th daily session, she “felt this lightness,” she remembers. “All of the sudden, this cloud was gone.” Her depression had finally lifted – and right on schedule, according to doctors, who say that patients often experience relief from TMS within two to four weeks. 

What Are the Side Effects?

There’s a very low risk of patients experiencing a seizure in TMS, says Irving Reti, an associate professor of psychiatry at Johns Hopkins University School of Medicine and director of the Brain Stimulation Program at Johns Hopkins Hospital. Side effects typically include a minor headache and localized pain underneath the magnetic coil. 

Another possible side effect, says Lindsey Carpenter, chief of the Mood Disorders Program and the Neuromodulation Clinic at Butler Hospital in Providence, Rhode Island, is a twitching or vibrating sensation around the face, cheek or scalp.

Rhodes says she didn’t experience any of the above symptoms, although she did occasionally take Tylenol to ward off potential pain. 

Who Gets TMS?

Research suggests ECT is a more effective treatment than TMS for relieving severe depression. Therefore, many patients choose ECT over TMS if they’ve tried multiple medications or therapies to no avail, or if they’re suicidal, psychotic or catatonic.

However, George says, some patients with treatment-resistant depression are reluctant to receive ECT – typically administered three times a week until a patient's depression is relieved, which can take anywhere from six to 12 sessions. They worry about memory loss, or they don’t want to invest the time. (Since ECT requires anesthesia, patients are generally out of commission on treatment days, and must rely on rides to and from appointments.) TMS, George points out, is also time-consuming, but it can be integrated into a daily routine. A person with depression that’s bad but not life-threatening might be a good candidate for TMS if they’ve already explored pharmaceutical options. If TMS doesn’t work, they might opt for ECT later down the line – a decision Rhodes says she might've made had the former treatment not worked for her.

Additionally, Carpenter points out, many psychiatric patients have multiple conditions or disorders, and therefore aren't good candidates for anesthesia. “We use TMS for a lot of patients that otherwise would’ve gone straight to ECT if they were healthier,” she says. 

On the other side, there are people who aren’t eligible to receive TMS, Reti says. Those with a history of seizures shouldn’t have it, as well as individuals who have metal in and around their head – say, a metal plate. (Braces and fillings are OK.)

Does TMS Work for Everyone?

Unlike Rhodes, not everyone in the medical community is convinced of TMS’s effectiveness. The National Institute of Mental Health calls the results of past clinical studies “mixed,” and the American Psychiatric Association says TMS offers patients “relatively small to moderate benefits.” Until recently, many insurance companies wouldn’t cover TMS. However, newer studies are showing promising remission and response rates among patients, as well as prolonged periods of improvement post-procedure.

George estimates that TMS can help up to one-third of patients achieve remission. And about 50 to 60 percent of patients show some response, he adds, meaning their depression symptoms have lessened. “It’s a pretty effective treatment,” he says.

But physicians warn that not all patients respond to TMS – nor can anyone predict who will respond. And although many insurance companies now cover TMS, some still don’t, and others require prior authorization. Medical assistance programs like Medicaid don't always pay for TMS. And out-of-pocket expenses for six weeks of TMS can total up to $10,000 – a lot for a procedure that might not work. “Unfortunately, that's the case with all our treatments in psychiatry,” Carpenter says. “It's one of the most pressing research questions: Who's going to benefit from a certain type of treatment so you can spare people the time, money and energy?”

Such was the question for Christy Moceri, a 31-year-old grant writer from Gainesville, Florida, who underwent TMS in July 2011. Like Rhodes, Moceri was a prime candidate for TMS – she’d experienced depression for years and encountered numerous side effects with medications.

“There isn’t a ton of research on TMS, but what my husband and I found was promising, and we could see that insurance companies were becoming more likely to cover it,” Moceri says. “We knew about the firmly established effectiveness of treatments like ECT and this seemed to be based on a similar theory. So we decided to take a gamble.” 

Initially, Moceri says, TMS made her feel better almost immediately. “Significantly, markedly better, with no side effects,” she says. “Everyone on staff [at the clinic] was very encouraged by my progress.” 

But her success didn’t last: Moceri once again slipped into depression and didn’t want to pay for follow-up treatments.

Additionally, doctors note, TMS patients often need a “top off” of sorts – brief booster treatments in case depressive symptoms return. Fortunately, Carpenter says, most TMS patients respond well to these maintenance TMS sessions. “If it got you better once, it’s extremely likely to get you better again,” she says, and much more quickly than the first go-around. Nevertheless, researchers still don’t know how to predict how long the benefits of TMS will last until a patient gets sick again.           

Rhodes doesn’t take antidepressants anymore, but she receives maintenance TMS once a month. Although it helps manage her depression, she says, serious depressive illnesses like hers are lifelong and recurring. “TMS is a tool, not a cure,” she says. The year following her first TMS treatment, Rhodes had several “tune up” treatments. She later experienced a depressive relapse and countered it with another 10 TMS sessions. If she goes too long without receiving it, she says, she experiences obsessive thought patterns, weepiness and agitation.

Overall, Rhodes says her life has been restored – even if her depression never quite leaves her side. “What I have achieved with this therapy,” she says, “is a sense of vitality – a sense of wanting to be alive.”

http://health.usnews.com/health-news/patient-advice/articles/2014/12/15/transcranial-magnetic-stimulation-what-is-it-and-who-needs-it

Wednesday, December 17, 2014

An electrical cause of stridor: Pediatric vagal nerve stimulators.

Int J Pediatr Otorhinolaryngol. 2014 Nov 21. pii: S0165-5876(14)00592-8. doi: 10.1016/j.ijporl.2014.10.037. [Epub ahead of print]

An electrical cause of stridor: Pediatric vagal nerve stimulators.

Kelts G1, O'Connor PD2, Hussey RW3, Maturo S4.

Author information
  • 1San Antonio Uniformed Services Health Education Consortium, Otolaryngology, United States. Electronic address: gregory.i.kelts.mil@mail.mil.
  • 2San Antonio Uniformed Services Health Education Consortium Center, Otolaryngology, United States.
  • 3San Antonio Uniformed Services Health Education Consortium, Pediatric Neurology, United States.
  • 4San Antonio Uniformed Services Health Education Consortium, Otolaryngology, United States.
Abstract

Vagal nerve stimulators (VNS) are surgically implantable medical devices which are approved by the food and drug administration (FDA) for treatment of medically refractory epilepsy in children. Two children with seizures disorders presented to the pediatric otolaryngology clinic with complaints of stridor and sleep apnea following implantation of VNS devices. Both children were evaluated with flexible laryngoscopy, direct laryngoscopy and bronchoscopy. The children were noted to have contraction of their vocal folds and supraglottis and the settings of their VNS were adjusted until no further contractions were noted. Each child had resolution of their symptoms following adjustment.

Published by Elsevier Ireland Ltd.

KEYWORDS:

Direct laryngoscopy; Sleep apnea; Stridor; Vagal nerve stimulator

PMID:
25500186
[PubMed - as supplied by publisher]
 
 http://www.ncbi.nlm.nih.gov/pubmed/25500186
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Vagus nerve stimulation could increase cardiac stability and reduce risk of SUDEP

Epilepsy

Vagus nerve stimulation could increase cardiac stability and reduce risk of SUDEP

Journal name:
Nature Reviews Neurology
Year published:
(2014)
DOI:
doi:10.1038/nrneurol.2014.243
Published online
16 December 2014

Article tools

An ECG study of individuals receiving vagus nerve stimulation (VNS) for drug-resistant focal epilepsy has demonstrated that VNS induces favourable changes in T-wave alternans, possibly reflecting improved balance between sympathetic and parasympathetic activity. T-wave alternans is an established noninvasive marker for risk of sudden cardiac death; the study finding, therefore,…

http://www.nature.com/nrneurol/journal/vaop/ncurrent/full/nrneurol.2014.243.html