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

Tuesday, November 25, 2014

“there is a major case happening within HHS/CMS regarding VNS Therapy for Depression”

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, November 25, 2014 1:06 PM
To: Courtney Turner
Subject: Follow-Up To Your Voicemail (11/24)

Dear Courtney,

I wish you and your family a very Happy and Peaceful Thanksgiving and as always thank you for the courtesy of your prompt replies.

For some time now I’ve sensed there is a major case happening within HHS/CMS regarding VNS Therapy for Depression.  It wasn’t until just recently that I was able to pin down the case without being able to obtain additional pertinent information.  What I found is the following:

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http://www.hhs.gov/dab/divisions/appellate/ncdappeals/complaints.html

I was wondering whether you could direct me to some Internet link and/or if you could explain as well as elaborate upon the aforementioned NCD Number and Board Docket Number as to the participants and the nature of this legal action.  Normally in a legal action one is able to research the docket number and read the nature of the plaintiff’s complaint/action.

At the moment, I’m stymied.

As always, thank you for the important help you’ve lent to some of these seriously ill patients who are most importantly continuing to do well through you’re assistance in obtaining replacement devices.

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

---------------------------------------------------------------

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: Tuesday, November 25, 2014 12:19 PM
To: Herbert Stein
Cc: Turner, Courtney (CMS/OHI)
Subject: Follow-Up To Your Voicemail (11/24)

Good Afternoon Mr. Stein,

I hope this e-mail finds you well.

I received your voicemail this morning. I apologize for not being able to call.  This is a short week and lots of activity is going on in the office. Everyone working to complete assignment and assist beneficiaries prior to the holiday. Unfortunately, I will not have the opportunity to return your call. However, I did want to reach out and ask you if you could send me your question via e-mail? This way, I can read, work and respond faster to your inquiry.

If I don’t hear from you prior to the holiday, have a great Thanksgiving. J

Sincerely,

COURTNEY

Friday, November 21, 2014

Need to see a psychiatrist? Call your insurance company first

21 November 2014, 9.24pm AEDT

Need to see a psychiatrist? Call your insurance company first

Author
  1. Tara F Bishop

    Assistant Professor of Healthcare Policy and Research, Assistant Professor of Medicine at Cornell University

Disclosure Statement

Tara F Bishop receives funding from the National Institute on Aging, the Commonwealth Fund, the Robert Wood Johnson Foundation, and the Physician's Foundation.

The Conversation is funded by CSIRO, Melbourne, Monash, RMIT, UTS, UWA, ACU, ANU, ASB, Baker IDI, Canberra, CDU, Curtin, Deakin, Flinders, Griffith, the Harry Perkins Institute, JCU, La Trobe, Massey, Murdoch, Newcastle, UQ, QUT, SAHMRI, Swinburne, Sydney, UNDA, UNE, UniSA, USC, USQ, UTAS, UWS, VU and Wollongong.

 

Not everyone can pay out of pocket. Stock image of counseling session via Monkey Business Images/Shutterstock

Last week, a patient contacted me to find a psychiatrist because his anxiety was beginning to get out of control. He wanted to see someone who could do therapy and prescribe medications if he needed them. I gave him some names but warned him that none of them took insurance. If he wanted to find a psychiatrist that took his insurance, he’d need to call his insurance company to find one.

And this situation is not uncommon in my primary care practice. I can treat simple psychiatric conditions like depression and anxiety but, like many internists, I do not have the training to provide therapy or treat more severe psychiatric conditions. If a patients needs psychiatric care, the best I can do is to offer them some recommendations and tell them to contact their insurance company. As you can imagine, this poses a barrier for patients trying to access the psychiatric care they need.

Half of psychiatrists do not take insurance

This motivated me to study psychiatrists and insurance. Last year, a team of researchers and I published a study using data from a national survey of doctors examining this issue.

We found that almost half of psychiatrists take don’t take health insurance – whether it’s private health insurance, Medicare (insurance for the elderly), or Medicaid (insurance for the poor).

Specifically, we found that in 2009 to 2010, only 55% of psychiatrists took private health insurance, 55% took Medicare and 43% took Medicaid. This presents a significant barrier for patients who need to see psychiatrists.

It’s important to emphasize that this was a sharp contrast to every other type of doctor. For example, 94% of cardiologists took private health insurance during that same time period and 95% of general internists took Medicare. When pooled together, 88% of physicians all specialties other than psychiatry took private health insurance and 86% took Medicare. Acceptance rates for Medicaid were low overall because reimbursement rates are low. Nevertheless, psychiatrists had some of the lowest Medicaid acceptance rates of all specialties.

The results shocked us and when our study was published last year, we learned that the results also shocked the general public.

Doctors, patients and reporters corroborated our findings. I started to hear more and more stories of patients who struggled to find a psychiatrist who took their insurance.

Less money for more work

So why is this the case? First, low reimbursement may be a problem. Medicare pays US$130 to US$140 for a new visit to a psychiatrist. Although that rate is not much different from a visit to a primary care doctor, visits to psychiatrists may be longer because they involve counseling and therapy.

Second, a shortage of psychiatrists may also be factor. From 2000 to 2008, 14% fewer medical students chose to pursue careers in psychiatry and 55% of psychiatrists are over 55 and close to retirement age. As a result, many psychiatrists may have so much demand for their services that they do not need to accept insurance.

Finally, psychiatrists may not have or need the administrative capacity that other doctors need. A psychiatrist may be able to function without a lot of staff like nurses, medical assistants, and administrative assistants. Because of this some psychiatrists may not be motivated to hire that staff just to interact with insurance companies.

Possible solutions

Since the time of our study, our team has been developing ways to further study the problem but also to explore solutions.

One obvious step is to increase reimbursement for mental health-care. But such changes can be difficult. Medicare relies on a review panel of physicians to change reimbursement and it is unclear whether that panel will suggest increased reimbursement for psychiatrists.

But there are other promising options that make it easier for patients to access mental health care. For example, the New York City Department of Health and Mental Hygiene runs a program called Lifenet which patients can call to find a psychiatrist or other mental health provider in New York City who takes their insurance.

Another very effective program, called Impact, was developed by faculty at the University of Washington and helps primary care physicians treat depression. A nurse, social worker or psychologist works closely with patients in the primary care doctor’s office and has a designated psychiatrist to help with patients who are not improving.

These are good starts but much more needs to be done in order to ensure access to psychiatrists across the board. For now, I have told my patient that he will probably have to pay for his psychiatric care even though he has insurance or will have to find someone who takes his insurance without my help.

Hopefully in the future, we will have more options for him.

http://theconversation.com/need-to-see-a-psychiatrist-call-your-insurance-company-first-33874

Thursday, November 20, 2014

11/20/2014 - Tidbits from Cyberonics' (CYBX) CEO Dan Moore on Q2 2015 Results - Earnings Call Transcript

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, November 20, 2014 10:02 PM


Subject: Tidbits from Cyberonics' (CYBX) CEO Dan Moore on Q2 2015 Results - Earnings Call Transcript

To all those concerned with VNS Therapy for Depression:

This morning’s conference call on Cyberonics yielded some cursory and interesting tidbits relating to VNS Therapy for Depression.  First item of interest was the fact an “estimated 35 implants” for depression in the past quarter.  The figure presented did not breakout new or replacement implants:

 

Rohan J. Hoare - Senior Vice President & Chief Operating Officer - Cyberonics

Thank you, Dan. First, the U.S. epilepsy market. The second quarter showed some improvement from the first quarter of fiscal 2015. First the good news: we estimate that a record number of patients were implanted with VNS in the U.S. during this quarter, including new patients, replacements, and an estimated 35 depression patients. However, U.S. sales fell short of our expectations. Although the comparative quarter last year was very strong, we expect more robust growth in an underpenetrated epilepsy market.

http://seekingalpha.com/article/2700285-cyberonics-cybx-ceo-dan-moore-on-q2-2015-results-earnings-call-transcript?part=single

 

In several of my previous collaborations there was a hint of something legal going on within CMS which was hush, hush?  No one cared to elaborate.  I’ve gleaned from today’s conference call the following information for whatever it is worth.  My opinion on the subject based upon today’s market reaction and an approximate 13% upswing in price despite what I would opine as lack-luster performance for the quarter is that something big is going on and there may have been some leakage of information that I feel could potentially be favorable to the VNS Therapy Depression patients.  Let’s put it like this; I certainly hope so.

 

Charles Haff-Craig - Hallum Capital Group LLC

Okay. Great. And then in terms of depression, and the tribunal for HHS, and the appeal process that's being done by the patient, do you have any update on this tribunal, or anything you can give us there?

Rohan J. Hoare - Senior Vice President & Chief Operating Officer - Cyberonics

No. I mean there are patient appeals in process and we've said we would continue to support both physician and patient appeals. Those just need to run their course through the normal justice system.

http://seekingalpha.com/article/2700285-cyberonics-cybx-ceo-dan-moore-on-q2-2015-results-earnings-call-transcript?part=single

 

Anyone’s thoughtful responses with information on this subject that I could also share publicly with fellow patients would be appreciated.

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

Wednesday, November 19, 2014

Challenges For People With Disabilities Within The Health Care Safety Net

Challenges For People With Disabilities Within The Health Care Safety Net



November 18th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7

Medicare and Medicaid were passed to serve as safety nets for the country’s most vulnerable populations, a point that has been reemphasized by the expansion of the populations they serve, especially with regards to Medicaid.  Yet, even after 50 years, the disabled population continues to be one whose health care needs are not being met.  This community is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that cover the population as a whole and their acute and long-term needs.

Nearly 57 million Americans had disabilities in 2010, and this number is likely to grow due to an aging population, advances in technology, and negative health trends such as obesity.  While the diversity of the group’s demographics and health issues can make it difficult to define “disabled,” how it is defined in policy can have significant implications for benefits, as well as stigma.  For example, the Social Security Administration narrowly defines disability as “the inability to engage in substantial gainful activity due to a medically determinable physical or mental impairment,” which disregards those who work in spite of their disabilities.  Meanwhile, the Americans with Disabilities Act (ADA) defines disability as “a physical or mental impairment that substantially limits one or more major life activities,” focusing on the condition rather than what a person can and cannot do.

The disparities for the disabled community are abundant: In comparison to nondisabled Americans, those with disabilities are more likely to be unemployed, impoverished, have less than a high school education, and have higher levels of risk factors such as obesity, smoking, and being physically inactive.  Moreover, disability prevalence is higher in minority groups such as blacks, American Indians, and Alaska Natives. However, the vulnerability of the disabled population does not stem simply from having a disability; more importantly, like other vulnerable populations, they are not well integrated into the health care system because of certain characteristics.  It is this inability to integrate the disabled into the health care system, and in turn society at large, that must be a focus of policymaking, including the Medicare and Medicaid programs, moving forward.

The Affordable Care Act (ACA) has taken steps that should help, such as expanding coverage, but disparities arise from health status and access to care as well.  To illustrate, one study looked at disparities between the disabled and nondisabled within Medicare to minimize the effect of coverage.  Nearly 50 percent of the disabled population reported putting off or not seeking care due to cost concerns, and they were more likely to have negative consequences as compared to nondisabled Medicare beneficiaries who delayed care due to costs.  Furthermore, disabled beneficiaries were three times as likely to have difficulties finding a doctor who accepted Medicare than nondisabled, and for the lucky that did 15 percent had difficulties finding doctors who actually understood their disability or how to treat it — not to mention obstacles arising from inadequate equipment and facilities, and insufficient communication, which is critical to patients’ rights of informed consent and bodily integrity.

The ACA contains provisions aimed at tackling some of these barriers to care, including standards for accessible medical diagnostic equipment, and developing trainings to provide culturally competent care to the disabled.  Proper training is critical as many of the health disparities that the disabled suffer are due to the fact that the health care system is not designed to care for this population effectively. The disabled suffer from others’ belief that they lack the ability to achieve high-functioning lifestyles, which is illustrated by the fact that health care staff rarely, if ever, emphasize health promotion.

This is not to insinuate that the issue of coverage, or coverage of the needs of the disabled, has been rectified.  A combination of states’ right to implement eligibility criteria, Medicaid being a target for budget cuts, and the disabled costing more than any other group has left many in the disabled community without much needed coverage.  The ACA originally expanded Medicaid to anyone at 133 percent of the federal poverty line (FPL), but the Supreme Court made this optional.  With 23 states still not moving forward on expansion, there is a need for advocacy and persuasion to try to limit the force of partisan politics.  While other safety net features are available, Medicaid can offer assistance to the disabled through long-term care as well as standard necessities.  Medicare on the other hand requires nonelderly disabled individuals receive SSDI benefits for at least 24 months — they must be unable to engage in gainful activity for at least 12 months to qualify for SSDI — and long-term institutional or community-based services are uncovered.

This perverse incentive to avoid work, or punish those that do work, is an issue the disabled community faces all too often.  Expanding employment options for the disabled is important not only monetarily, but also to enhance their ability to live independently and interact with their social environment.  Too often they are cut off from large parts of society, which undoubtedly lead to their higher rates of depression and mental illnesses.  The Community Living Assistance Services and Supports (CLASS) Act aimed to help alleviate some of the concerns over long-term care, but it was ultimately deemed unsustainable.  Nevertheless, with the disabled population growing, leaving their long-term medical needs to linger until they become more costly is not an economically efficient solution.

The safety net that Medicare and Medicaid aimed to create 50 years ago is still filled with far too many gaps when it comes to the disabled.  The ACA has taken some important steps, but more needs to be done to ensure the health care system, including Medicare and Medicaid, reduces its barriers to health.  Coupling policy changes with better information and training should also contribute to a much needed normative change, so that we no longer perceive those with disabilities as having something wrong with them or being unable to function “normally.”  It is essential that as a country we recognize that health disparities for the disabled are associated less with their disability and more with our inability to structure the societal and health care framework to allow them to function optimally.

http://healthaffairs.org/blog/2014/11/18/challenges-for-people-with-disabilities-within-the-health-care-safety-net/

It's not about patient care and wellness. It's not about experimental treatments. It's all about money and profits (Part 1)

 

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, November 19, 2014 3:15 AM


To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director; Stephen J. Hemsley - CEO, United Healthcare; Chet Burrell, President & CEO CareFirst BlueCross BlueShield


Subject: It's not about patient care and wellness. It's not about experimental treatments. It's all about money and profits (Part 1)

Dear Madam Secretary Burwell,

Nope, you haven’t heard the last from me.  I’ve just been busy caring for my spouse Joyce and taking a little break from my advocacy/activism to recharge my batteries.  Although this past week or so has proven interesting as I’ve received two (2) emails one of which I am awaiting permission to share publicly.

One of those emails was from another VNS study subject who advised me that her health insurance company, BlueShield and BlueCross of South Carolina has denied her replacement surgery for her VNS prosthesis.  Cyberonics who guaranteed replacement for all the study subjects, of which she is one, has also denied her replacement coverage.  Despite the fact that she is doing well these past 14 or so years and game fully employed as a professional her health insurance company, both from a medical and financial standpoint, exhibit their stupidity in not understanding they’ve been saving money.  That is until she lapses back into depression and the medical expenses begin to mount.  And you Madam Secretary and your bureaucracy continue to sit there without understanding or aiding these patients.  Nor does it seem you’ll understand that if and when she lapses back into depression and is unable to work she’ll eventually end up on Medicaid and/or social security disability while being treated with the same ineffective treatment regimens and medications that cost our country trillions of dollars when all that need be done is for her to continue her current VNS treatment regimen and wellness as well as a taxpaying citizen.

I truly hope you’re proud of the agencies you command and the injustices and medical and moral negligence and inhumanity your FDA and CMS agencies has perpetrated against innocent citizens.  Your agencies have truly victimized these patients despite having health insurance and being denied medical coverage.  Why have you not had CMS issue a formal document not only to your Medicare/Medicaid agencies but to the private health insurance carriers informing them that all patients implanted prior to National Coverage Analyses (NCA) of May 4, 2007 are to rightfully to be covered for their medical care?  How can you allow patients to be implanted with medical devices and have their health insurance carriers deny coverage?  How can the government standby and allow Cyberonics to issue a guarantee of medical care and allow them to renege on that very care?  Oh I forgot, our wonderful governmental bureaucracy and “it’s not my job”.  Maybe we should add several more agencies to our already bloated bureaucracy to correct the problem (joke; only it’s not funny).  It seems no one in government knows how to do “the right thing” other than to create more agencies and do nothing bureaucracies where one hand doesn’t know what the other hand is doing (i.e. “9/11” and CIA, FBI and local police departments, Federal fraudulent tax returns and IRS, FBI and local police departments and Pain Clinic Fraud and Medicare/Medicaid and VNS Therapy and FDA, Cyberonics and CMS all lacking effective communication) but to name a few.

The other item of interest came in another email regarding the name of Dr. Amy Schneider.  Her name first appeared to me as a medical authority who wrote a psychiatric medical opinion for United Healthcare as to why their private pay subscriber should not be allowed to have her VNS prosthesis replaced and paid for by her insurance.  Then oddly enough I just learned that the same Dr. Amy Schneider issued her medical opinion to United Healthcare once again in a different case as a medical authority on oncology.  It seems Dr. Schneider was denying a cancer patient the use of a less invasive and less damaging radiation treatment.  It seems to me that United Healthcare exhibits a lack of medical ethics in what appears to me to be a hired gun (hack) to justify denial of coverage.  I’d say to Stephen J. Hemsley - CEO, United Healthcare that you couldn’t care less and didn’t help your subscriber, the VNS patient that I wrote to you and advocated for, but in this case I think you and your company have got its nuts in a wringer and you’re going to be taken to task for your lack of humanity and ethics.  Bless the Internet.  These people came across my previous commentary to you about your Dr. Amy Schneider and it greatly raised their interest.  To you Mr. Hemsley I say both you and your company have been, “Penny wise and pound foolish”.

All the hoopla has passed regarding the death of Robin Williams and his suicide.  The media has finished their frenzy of 24/7 non-stop verbiage about the tragedy but the fact remains that those of us on the frontlines know the issues and the deaths will continue and the reason for our continuing advocacy and activism for newer treatments and the dissemination of needed information.

Dear Madam Secretary Burwell it’s truly disgusting for me to sit here and watch people suffer especially when you and others have the authority and ability to ease the pain, anguish and suffering by doing good and what is truly the right thing.

Is it not time for you too to provide and care for these 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

---------------------------------------------------------------

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.

Tuesday, November 18, 2014

Magnetic therapy gains favor in battling depression

Magnetic therapy gains favor in battling depression

Neuropsychiatrist Dami Salami (left), medical director of the repetitive transcranial magnetic stimulation program at Froedtert & the Medical College of Wisconsin, says rTMS has been successful in treating depression. With Salami is Yagna Pathak, an rTMS technologist and researcher.

Michael Sears
Neuropsychiatrist Dami Salami (left), medical director of the repetitive transcranial magnetic stimulation program at Froedtert & the Medical College of Wisconsin, says rTMS has been successful in treating depression. With Salami is Yagna Pathak, an rTMS technologist and researcher.

By John Keilman, Chicago Tribune

Nov. 18, 2014 10:07 a.m.

 

Chicago — A machine that sends magnetic pulses into a patient's brain has become the new frontier of depression treatment, promising to ease symptoms for those who have found little relief from medication or talk therapy.

The treatment, known as transcranial magnetic stimulation, or TMS, is part of a wave of technologies that attempt to jolt the brain back to health. It caught on quickly after the Food and Drug Administration approved its use six years ago.

A form of it called repetitive transcranial magnetic stimulation, or rTMS, is being used with success at Froedtert & the Medical College of Wisconsin, according to neuropsychiatrist Dami Salami, an assistant professor of psychiatry and behavioral medicine at the Medical College of Wisconsin. Salami is medical director of the Froedtert & Medical College rTMS program.

"It's very promising, and I suspect it's going to be a major tool going forward," he said, noting that there's "limited awareness of this new treatment option." It has been used at Froedtert & the Medical College since 2011.

Though some have questioned the technology's effectiveness, more insurance companies are starting to cover it, helping with a price tag that can reach $10,000 for six weeks of treatment. It's covered by Medicare, Salami noted.

"What this does is raises (your mood) up to normal," a 55-year-old woman from the western Chicago suburbs said after finishing a treatment session at Linden Oaks at Edward in Naperville, Ill. "You can operate."

Stimulative brain therapies have been around for decades, the best known being electroconvulsive therapy, a technique that uses an electric current to cause a seizure. It was portrayed as a mind-erasing menace in the movie "One Flew Over the Cuckoo's Nest," though psychiatrists say the procedure is safe today.

Other methods use implanted devices to send electrical pulses to the vagus nerve — a transmission line that carries messages to the brain's mood center — or to the brain itself. Some studies have found that these techniques help to elevate the moods of people with severe depression.

Mark George, a South Carolina psychiatrist who edits the medical journal Brain Stimulation, said TMS produces similar effects without the need for surgery.

A patient sits in a chair that resembles something from a dentist's office as a device containing the magnetic coil is placed on his head. When it's activated, George said, magnetic pulses penetrate the skull and stimulate nerve cells — the Linden Oaks patient described the sensation as "having a woodpecker sitting on your head" — provoking a therapeutic response.

George acknowledged that the technology doesn't work for everyone. Early studies, which relied on subjects who had been taken off their medications, found that only about 15% saw their depressive symptoms go away.

But later research that allowed subjects to stay on their meds, which George called a more true-to-life test, found that 40% had complete relief from their symptoms, while 60% got at least somewhat better.

Salami says the repetitive TMS he uses involves a brain MRI to identify a specific treatment site, is more targeted than traditional TMS and has been effective in 80% of cases. By contrast, he notes, the response rate for medication is 50% to 60%.

The treatment is especially helpful in what he called resistant cases of depression, defined as those who have not experienced remission of depressive symptoms after at least two treatment modalities — meaning medications and/or therapy.

"It uses magnetic field pulses over a specific period of time," he said of the method used at Froedtert & MCW. "The repetitive nature is key with treatment resistant cases. We can modify the way we deliver treatment, and the treatment parameters ... the strength of treatment parameters. ... We can increase the magnetic field current and frequency, and the band width."

It's not as effective as electroconvulsive therapy, which has full remission rates of around 60%, but George said that treatment requires patients to be anesthetized and is known to cause memory and cognitive problems in some.

TMS, by contrast, requires no sedation, and its biggest complication appears to be discomfort where the magnets are placed on the head.

Salami said rTMS doesn't carry with it the side effects of medications, and patients can return to work or other activities after a treatment session. The treatment has been used for patients with Parkinson's disease and for chronic pain at other centers, he said, and there are ongoing studies looking into its effectiveness in other disorders, including obsessive compulsive disorder.

"It's a highly effective treatment and has only trivial side effects," said physician Jesse Viner, medical director at north suburban Evanston's Yellowbrick psychiatric health care center. "There's no persistent adverse effect. You can have a little bit of a headache or facial pain, but that quickly subsides, and in our experience, by the time people have their third or fourth treatment, they're OK."

The effectiveness of TMS came into question in 2007 when the FDA was considering its use as a depression treatment. The Washington-based advocacy group Public Citizen, which often tangles with the agency over what it considers lax standards for medical devices, claimed the study the FDA relied on was unreliable.

The data at first showed that TMS was not significantly superior to a "sham treatment" that didn't subject patients to the magnetic pulses, the group said: Better results from TMS were evident only when some subjects were removed from the trial, and even then the difference was small.

What's more, the group said, patients receiving TMS knew they were getting something because unlike the sham treatment, the pulses produced a painful sensation.

"Given the small differences we were seeing, that could have been explained by the placebo effect," said physician Michael Carome, director of Public Citizen's health research group.

Physician David Brock of Neuronetics, the Pennsylvania-based company that sought FDA approval for its TMS machines, pointed to a rebuttal by the study's authors that defended their methodology and cited the improvement made by patients who received the treatment. Subsequent research, Brock said, has further demonstrated the effectiveness of the technology.

The FDA decided to allow TMS as a depression treatment, and many Medicare contractors have since covered the service. Though private insurance companies remain split, with companies such as Blue Cross and Blue Shield of Illinois paying for TMS and others declining to do so, more than 100 million people now have coverage for the treatment, Brock said

That has encouraged more health care providers to invest in the machines, which physicians say cost $75,000 to $90,000. But Rad Gharavi, a suburban Oak Park, Ill., psychiatrist who has offered the service for four years, said insurance problems remain.

Coverage begins only after a patient has failed to get better after trying antidepressants. Gharavi said that can force patients to endure the side effects of medications for months.

"That means we are essentially delaying treatment," he said. "TMS can literally take away all the symptoms in six weeks."

It was more complicated than that for the Linden Oaks patient, who has dealt with depression since she was a teenager. She first received the treatment four years ago but comes for follow-up treatments every three months or so when she "can feel the beast creeping up," she said.

"It's apparently very individualized," she said. "There's been a bit of fine-tuning in terms of knowing when to come back for a booster."

Philip Janicak, a psychiatrist who has researched and performed TMS and is now helping Linden Oaks set up its program, said a recent study to which he contributed found that, generally speaking, the effects of the treatment last for a year.

With TMS now firmly established as a depression treatment, Janicak said research is turning to other possible uses, from migraines to Parkinson's disease to post-traumatic stress disorder.

"I see us really at the opening of this era," he said. "There's a lot of things we can do with this technology to help people, and we're just starting to touch the surface of it with depression."

For information on repetitive TMS at Froedtert and the Medical College of Wisconsin, call (414) 955-8952.

Jan Uebelherr of the Journal Sentinel staff contributed to this report.

http://www.jsonline.com/news/health/magnetic-therapy-gains-favor-in-battling-depression-b99380178z1-283055921.html