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Saturday, March 31, 2012

Important Treatment Option for Depression Receives Medicare Coverage

Important Treatment Option for Depression Receives Medicare Coverage

3/30/12 11:16 AM
Providence, R.I. - Transcranial Magnetic Stimulation (TMS), an FDA approved treatment for depression that Butler Hospital began offering in 2008, is now covered by Medicare. Thanks to the work of advocates like Dr. Linda Carpenter, Butler’s Chief of Mood Disorders and the Neuromodulation, patients in New England with Medicare coverage are able to receive this innovative, effective treatment for acute depression.

Butler was one of the first hospitals in the region to offer TMS therapy three years ago. At the time, Dr. Carpenter was excited for the hope this treatment could bring to patients unable to find symptom relief through medication. What Dr. Carpenter didn’t anticipate was that in addition to providing treatment and care for her patients using TMS, she’d also spend months advocating on their behalf, writing countless appeals letters to insurance companies who were reluctant to pay for the treatment, and representing the patients in legal and community hearings to make the case for coverage of the new treatment.

“The initial FDA approval of TMS therapy gave hope to many psychiatrists who saw patients whose symptoms were not relieved through traditional medications,” states Dr. Carpenter, adding that it wasn’t until she began treating patients with TMS that she realized how difficult an obstacle she and her patients would face trying to convincing insurers that this was the best and only line of treatment that could relieve their symptoms.

Treatment with TMS is reserved for patients whose depression does not improve with antidepressant medication therapy. Unlike more invasive options after medication, like vagus nerve stimulation (VNS) which requires surgery, and electroconvulsive therapy (ECT) which requires anesthesia, TMS uses a noninvasive device that beams magnetic pulses through the skull of an awake patient, to stimulate the brain and induce electrical activity in circuits throughout the brain involved in major depression. During TMS Therapy, patients sit in a chair that resembles something one might find at a dentist office. An MRI-strength magnet is positioned near the patient’s scalp on the left side, aimed at the prefrontal cortex. The treatment sessions each take about 30 minutes and are recommended five times a week for up to six weeks.

“TMS is a game changer for the treatment of depression. And now that Medicare has approved coverage of TMS for the patients who need it, we’re hopeful that other insurers will follow,” said Dr. Carpenter. “Since it was approved by FDA in 2008, ongoing research has consistently shown the benefits of TMS for patients with depression. Medicare’s decision to cover the treatment really reflects how strong the science is, which will in turn help many clinicians and patients realize that TMS is safe and effective.”

Butler Hospital is the only private, nonprofit psychiatric and substance abuse hospital serving adults, adolescents and children in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The flagship hospital for the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research.,66462

3 comments on this story|Add your comment
Herbert wrote:
This article is seriously misleading in my opinion especially the following quotation:

"And now that Medicare has approved coverage of TMS for the patients who need it, we’re hopeful that other insurers will follow,”

I strongly feel Dr. Carpenter was probably misquoted and made no such statement. While maybe there have been instances of Medicare approving coverage on a case by case basis, upon additional investigation and several conversations, I've learned there is no formal CMS (Centers for Medicare/Medicaid Services) approval for this therapy option.

Had there been such an approval I'm certain the sponsor of the therapy would be all over the media promoting its formal approval.

I am an advocate for additional treatment options knowing that many of the conventional therapies have proven ineffective for this unique population of patients.


Yesterday at 4:10 AM

Severon wrote:
Herb, not hard to determine the motive for your blatant lies given your user name vns therapy (vagal nerve stimulation therapy- the surgical implantation of a electronic stimulator, a now defunct treatment not longer covered by insurance companies or Medicare for depression)

TMS DOES HAVE MEDICARE COVERAGE IN NEW ENGLAND, please click below to read the press release from the company that makes the policy decisions for Medicare in New England, and the company, NHIC's own update to announce the coverage:

You are an advocate of your treatment, which requires a surgical procedure, and has been proven inneffective for depression.
You are either very ill-informed, malicious, or jealous. After posting your retraction, please do not speak for Medicare or their local coverage determinations, unless your intention is to mislead, which of course you seem very effective at when unchecked by the truth.

7 hours ago

Herbert wrote:
Hi Severon,

First, I say thank you for the informational links you’ve listed.

Secondly, I live and learn every day and most often from those who would politely take the time to share with me. As for my motives and any other personal assessment you may have of me, you’re grossly off base.

What is truly fascinating to me is the fact that there has been no national determination by CMS to the best of my knowledge as was the case with VNS Therapy for Depression. Those many years ago, being a total novice, I thought once the FDA approved a treatment that was it. Go know, I believe for the first time, a medical device treatment was FDA approved but CMS – National declined reimbursement and the rest is history along with a number of other issues.

Now, I learn from you by way of citing those two links that it appears each and every state or district can make their own Medicare determination. Again, thank you. I was not aware of that fact.

I am an advocate for patient education while encouraging hope and persistence. I also advocate for research into newer treatment options because the conventional therapies have proven ineffective for this seriously ill large population of patients. As a very, very long-time support person and health care advocate for my spouse I personally am happy to read about this decision as TMS would be an option I would consider before for ECT or VNS for a number of reasons.

I do not endorse or promote the use of any treatments, products and/or companies contrary to any of your beliefs.

Now I would like to see if in fact Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont actually follow through on this decision and if the private insurance carriers follow suit?

Since you are familiar with the situation and you do have my email address I’d appreciate your taking time, if you don't mind, to try to keep me updated as events unfold. I shall share this information with a number of others who do have interest in this and other alternative treatment options.

Thanks again, your reply was most appreciated.


12 minutes ago

Local Coverage Decision from Medicare Administrative Contractor Cites CEPAC in Coverage Policy  

-- Draft non-coverage policy changed, noting the role played by an adapted comparative effectiveness report from the Agency for Healthcare Quality and Research and the New England Council public votes --

Boston, Mass., January 30, 2012 –The Medicare Administrative Contractor for most of New England, NHIC, Corp, has issued a final local coverage decision granting first-in-the-nation Medicare coverage for repetitive transcranial magnetic stimulation (rTMS) for patients with treatment-resistant depression. The new coverage policy, which takes effect in March, reverses a non-coverage draft policy posted in November 2011, and represents the first positive local Medicare coverage policy for rTMS in the nation. In describing the factors considered for this policy change, the Medicare Contractor cited numerous comments and statements received from patients and clinicians, several of which cited the comparative effective review produced by the federal Agency for Healthcare Research and Quality (AHRQ), supplementary analyses of this report prepared for the New England Comparative Effectiveness Public Advisory Council (CEPAC), and the votes taken by the CEPAC as part of its public deliberation on the evidence.

CEPAC convened in Providence, Rhode Island in December 2011 to consider the evidence on the comparative clinical effectiveness and comparative value of a variety of nonpharmacologic interventions for patients with treatment-resistant depression. CEPAC is the central component of a project funded by AHRQ and directed by staff from the Institute for Clinical and Economic Review (ICER), a leading academic comparative effectiveness research group based at the Massachusetts General Hospital’s Institute for Technology Assessment in Boston.
“Our goal in creating CEPAC was to improve the application of good evidence to policy decisions by regional health insurers, and to encourage the use of evidence by clinicians and patients as well,” stated Steven D. Pearson, MD, MSc, President of ICER. “We are gratified that the AHRQ report, our supplemental analyses, and CEPAC’s deliberation and voting were all noted by stakeholders engaged in the coverage process, and ultimately cited by the Medicare Contractor as influential elements in his final coverage decision for the use of rTMS in treatment-resistant depression. Having an independent group of physicians and public representatives deliberate on these issues and render specific judgments about the evidence is an important step in reaping the benefits of comparative effectiveness research.”

The full coverage policy from the Medicare Administrative Contractor is available online. NHIC, Corp is the Medicare Administrative Contractor for Jurisdiction 14, which covers Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont, serving 1.3 million Medicare beneficiaries and more than 53,000 healthcare providers.

At its December 2011 meeting, CEPAC voted 10 to 5 that the evidence was adequate to demonstrate that for patients with treatment-resistant depression rTMS was as good, or better, than usual care (i.e. general supportive psychotherapy with or without continued use of antidepressant medication). CEPAC also voted 9 to 6 that the evidence was adequate to demonstrate equivalent or superior outcomes for rTMS compared to electroconvulsive therapy (ECT). CEPAC then reviewed evidence on the cost-effectiveness and potential budget impact of rTMS and the majority voted that, at current Medicare reimbursement rates, the use of TMS represents “reasonable value” when compared to usual care and a “low value” when compared to ECT. The final CEPAC meeting report includes supplementary analyses to augment the AHRQ review of nonpharmacologic interventions for treatment-resistant depression in adults. The report also reviews the results of all the votes taken by CEPAC on the adequacy of evidence to demonstrate the comparative clinical effectiveness and value of different approaches to treatment-resistant depression.

CEPAC is a regional body whose goal is to provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions across New England. Supported by a federal grant from the Agency for Healthcare Research and Quality (AHRQ), and with backing from a consortium of New England state health policy leaders, CEPAC holds public meetings to consider evidence reviews of medical tests and treatments and provide judgments regarding how the evidence can best be used across New England to improve the quality and value of health care services. CEPAC consists of practicing physicians with experience in evaluating and using evidence in the practice of healthcare, as well as patient/public members with experience in health policy, patient advocacy and public health.

ICER is managing the day-to-day operations of CEPAC as part of its federally funded RAPiD (Regional Adaptation for Payer Policy Decisions) initiative meant to develop and test new ways to adapt federal evidence reviews to improve their usefulness for patients, clinicians, and payers. Nominations are currently open for new members of CEPAC. A list of CEPAC members, information on nominations and other information about the project, is available online at

About ICER
The Institute for Clinical and Economic Review (ICER), based at the Massachusetts General Hospital’s Institute for Technology Assessment (ITA) and an affiliate of Harvard Medical School, provides independent evaluation of the clinical effectiveness and comparative value of new and emerging technologies. Structured as a fully transparent organization, ICER seeks to achieve its ultimate mission of informing public policy and spurring innovation in the use of evidence to improve the value of health care for all. For more information, please visit

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