National Coverage Analysis (NCA) View Public Comments

Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)

Public Comments

Commenter Comment Information
Counts, Nathaniel Title: Senior Policy Director
Organization: Mental Health America
Date: 12/19/2018
Comment:

Mental Health America (MHA) thanks the Centers for Medicare and Medicaid Services (CMS) for reconsidering the National Coverage Determination (NCD) for Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD).

MHA – founded in 1909 – is the nation's leading community-based nonprofit dedicated to addressing the needs of those living with mental illness and to promoting the overall mental health of all Americans. Our work is driven by our commitment to promote mental

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Monacelli, Carla Title: Vice President, Government Affairs and Market Acce
Organization: LivaNova
Date: 12/19/2018
Comment:

December 19, 2018

Tamara Syrek Jensen, Esq.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
The Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244

Re: LivaNova Comments on Proposed Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-00313R2)

Dear Ms. Syrek Jensen,

On behalf of this underserved and

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Sackeim, Harold Title: Professor, Psychiatry and Radiology
Organization: Columbia University
Date: 12/19/2018
Comment:

I am commenting on the Proposed Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD) (CAG-003113R2). I have considerable clinical and research experience with both VNS and TRD. I am a Professor in the Departments of Psychiatry and Radiology, Columbia University, and the Chief Emeritus of the Department of Biological Psychiatry, New York State Psychiatric Institute. I directed one of the four sites in the first trial of VNS in TRD (Rush et al., 2000),

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Venkataraman, Rashi Organization: AHIP
Date: 12/19/2018
Comment:

Thank you for the opportunity to provide comments on the Centers for Medicare and Medicaid Services (CMS) proposed national coverage determination of Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD).

AHIP is the national trade association whose members provide coverage for health care and related services to millions of Americans every day. Through these offerings, we improve and protect the health and financial security of consumers, families, businesses,

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Sperling, Andrew Title: Director of Legislative Advocacy
Organization: National Alliance on Mental Illness
Date: 12/19/2018
Comment:

The National Alliance on Mental Illness (NAMI) is pleased to submit the following comments on the proposed CMS Decision Memorandum on coverage under Medicare for Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD). As the nation’s largest organization representing people living with serious mental illness and their families, NAMI commends CMS for moving forward to expand coverage for treatment.

Depression carries an enormous public health burden for our nation

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Kutzer, Dennis J Title: MD
Organization: Sheppard Pratt Health Systems
Date: 12/19/2018
Comment:

Dennis J Kutzer, MD
Service Chief, Crisis Admissions Unit
Sheppard Pratt Health System
6501 N. Charles Street
Baltimore, MD 21204
410-938-5435
djkutzer@sheppardpratt.org

I am a front line psychiatrist with over 35 years of experience. I have focused my clinical care for individuals with difficult to treat Major Depressive Disorder, Bipolar Disorder Type I and II and Schizophrenia. I am currently following six patients all with Bipolar Disorder who were part

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Timmons, MD, PhD, Shelly D. Title: President
Organization: American Association of Neurological Surgeons
Date: 12/19/2018
Comment:

December 19, 2018

Tamara Syrek Jensen, Esq.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
7500 Security Blvd. Baltimore, MD 21244

Subject:    CMS Proposed Decision Memo for Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD) (CAG-00313R2)

Dear Ms. Jensen:

The American Association of Neurological Surgeons (AANS),

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Zajecka, MD, John Title: Professor of Psychiatry
Organization: Rush University
Date: 12/19/2018
Comment:

I am sending this comment after careful review of the CMS comments regarding Vagus Nerve Stimulation (VNS) for Medicare coverage of VNS for the FDA approved indication of treatment resistant depression (TRD). I appreciated the broad range of reviewers who apparently consolidated their comments in the review. However, as a psychiatrist for over 30 years doing both clinical research as well as managing the challenges of TRD daily, I cannot help but state that the comments are not consistent

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Capote, Horacio Title: Medical Director
Organization: Dent Neurologic Institute
Date: 12/18/2018
Comment:

Dear Dr. Susan Miller, Lead Medical Officer & David Dolan, MBA, Lead Analyst,

I am delighted to see that CMS is reconsidering its stand on Vagal Nerve Stimulation. I am the Medical Director of the Division of Neuropsychiatry at Dent Neurologic Institute in Buffalo, New York. This is America’s largest freestanding neurosciences institute. We have significant experience with treatment resistant depression and offer a wide variety of treatments. I currently have approximately 3

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Carpenter, Linda Title: Chief, Mood Disorders Program; Professor
Organization: Butler Hospital/Brown Department of Psychiatry& Human Behavior
Date: 12/18/2018
Comment:

Dr. Susan Miller, Lead Medical Officer
David Dolan, MBA, Lead Analyst.

Dear Dr. Miller and Mr. Dolan,

I appreciate this opportunity to provide comments about the proposed expansion of coverage for VNS to treat TRD. I am a clinical researcher with more than 2 decades of experience conducting TRD device-based clinical trials such as the one CMS is calling for with CED criteria, including several large multi-site VNS trials sponsored by Cyberonics. Additionally, I am a

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Lehman, Robert Title: M.D.
Organization: Pharmasite Research
Date: 12/18/2018
Comment:

I am very interested in the approval in the near future of vagal nerve stimulation for the treatment of Treatment resistant depression. This is a population that is very vulnerable in terms of suffering, and become a very significant burden to family and to society because of difficulty managing day-to-day life. Rates of family failure and unemployment are quite high. The cost of treatment for patients with treatment resistant depression is very significant both on an outpatient and

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Short, Baron Title: Medical Director of Brain Stimulation Service
Organization: Medical University of South Carolina
Date: 12/18/2018
Comment:
I am the medical director of the Brain Stimulation Service at the Medical University of South Carolina. Our division includes a variety of brain stimulation methods for treatment resistant psychiatric disorders. We employ electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS, and deep brain stimulation (DBS). We were one of the first centers to have VNS implanted for treatment resistant depression (TRD). Dr. Mark George, the division director,

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Horne, Linda Title: MD
Organization: Dr.
Date: 12/18/2018
Comment:
As a practicing clinician for 28 years who had a number of patients in the initial clinical trials, I can attest to the benefits of this treatment in patients who have failed all other options - patients who I had nothing left to offer. Given the positive clinical data, including long-term data, the mortality rate of Major Depression, and FDA approval for VNS for TRD, I am unable to understand why this life-saving treatment was not covered prior. As you are aware, your lack of coverage led to

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Leahey, Mark Title: President & CEO
Organization: Medical Device Manufacturers Association (MDMA)
Date: 12/18/2018
Comment:

December 18, 2018

Via Electronic Submission

Re: Public Comments in Response to the Reconsideration of National Coverage Determination (NCD) 160.18 for Vagus Nerve Stimulation (VNS) for Treatment of Resistant Depression (TRD)

Dear Dr. Susan Miller and Mr. David Dolan,

On behalf of the Medical Device Manufacturers Association (MDMA), a national trade association representing hundreds of innovative companies in the field of medical technology, I am pleased to

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Foxworth, Phyllis Title: Advocacy Vice President
Organization: Depression and Bipolar Support Alliance
Date: 12/18/2018
Comment:

December 17, 2018

Ms. Seema Verma
Administrator
Centers for Medicare & Medicaid Services

Re: Vagus Nerve Stimulation (VNS) for Treatment Resistant Depression (TRD)

I am writing on behalf of the Depression and Bipolar Support Alliance (DBSA) the leading peer-led organization for people with the lived experience of a mood disorder: depression or bipolar disorder. These serious, all-too-often life-threatening conditions combine to affect more than 21

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Kannan, MD, Hari D. Organization: Kannan Clinic, P.C.
Date: 12/18/2018
Comment:
I have been a practicing Psychiatrist for decades. As such, I recognize that Major Depression is a disease associated with significant morbidity and mortality despite the availability of a multitude of pharmacological, non-pharmacological and biological treatments. Even with all the advances that have been made in our therapeutic options, great challenges remain in achieving remission of disease for many patients with Major Depression. In this context of profound human suffering and less than

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Greenberg, Pamela Title: President and CEO
Organization: Association for Behavioral Health and Wellness
Date: 12/17/2018
Comment:

December 17, 2018

Tamara Syrek Jensen, JD
Centers for Medicare & Medicaid Services
Director, Coverage and Analysis Group
7500 Security Boulevard
Mail Stop S3-02-01
Baltimore, MD 21244-1850

Dear Ms. Jensen:

I am writing on behalf of the Association for Behavioral Health and Wellness (ABHW). ABHW is the national voice for payers that manage behavioral health insurance benefits. ABHW member companies provide coverage to approximately 200 million

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Williams, Nolan Title: Assistant Professor
Organization: Stanford University
Date: 12/17/2018
Comment:
VNS has been a lifesaver for a number of my patients.
Moreno, Francisco Title: Professor of Psychiatry, Associate Vice President
Organization: University of Arizona Health Sciences
Date: 12/17/2018
Comment:

Thanks for the opportunity to comment on the VNS for TRD proposed protocol.

I have served as PI of several protocols utilizing VNS for TRD and have overseen the treatment of dozens of individuals. Some of them I still provide treatment or consultation for. I have been impressed by three important observations:

1.- Individuals who have improved after treatment with VNS for TRD but did not approach or sustained remission, may have life changing benefit even when

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Aaronson, Scott Title: Director, Clinical Research Programs
Organization: Sheppard Pratt Health System
Date: 12/16/2018
Comment:

After many years working on the TRD registry trial, it is heartening to see some clear progress on making VNS available to patients with severe treatment resistant depression. I am however concerned about misperceptions of my paper in the American Journal of Psychiatry and how it is applied to the current recommendation for a randomized clinical trial. The cohort for the paper involves following patients over five years. Both the response and remission rates reported grow over time.

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Chandragiri, Satyanarayana Title: MD Psychiatrist
Organization: Chandras Clinic PC
Date: 12/16/2018
Comment:

Vagal Nerve stimulation
I am a practicing Board Certified Psychiatrist in Oregon. I have been practicing for 30 yrs. I had previously commented on why CMS should allow Medicare to cover V N S implantations, follow up, replacement of device for Treatment Resistant Depression. I would like CMS to reconsider the requirement of requiring an RCT study before considering VNS as a covered procedure for TRD.

I believe this requirement is going to place undue burden on those who

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Grove, M.D., Gary Title: Psychiatrist
Date: 12/15/2018
Comment:

I am a psychiatrist in private practice and on faculty at the Mayo Clinic School of Medicine in Arizona. I have treated numerous patients with TRD over the 26 years I have been in practice. I used VNS in 10 patients and would have treated more, except that Medicare withdrew funding, with private insurers following suit.

Of the 10 patients, who had failed nearly every treatment known, including ECT in some cases, 8 had a meaningful result and 5 achieved remission. Recently, a

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Conway, Charles Title: Professor of Psychiatry
Organization: Washington University School of Medicine
Date: 12/15/2018
Comment:

I am very pleased that CMS has decided to pursue a coverage with evidence randomized clinical trial for vagus nerve stimulation (VNS) in Treatment Refractory Depression (TRD).

I am a Professor of Psychiatry at Washington University Department of Psychiatry in St. Louis and have been working in the area of VNS for TRD for the past 17 years. I have been intimately involved in both the clinical trials assessing efficacy for this treatment, as well as the scientific studies

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Tendler, Aron Title: MD
Organization: Advanced Mental Health Care Inc.
Date: 12/15/2018
Comment:

Thank you for moving forward with this CED for VNS. TRD is an enormous issue which contributes to morbidity, disability and more options are essential. I am a board certified psychiatrist and sleep specialist. I am also the chief medical officer for Brainsway, (a deep TMS manufacturer) and I conduct clinical trials. I have been a PI on nine clinical trials. There are several comments I would like to make regarding the design of the current study.

VNS naturally is self selecting

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Canterbury, Randolph Date: 12/14/2018
Comment:
I provided VNS treatment for treatment resistant major depression early on. I had three patients who received VNS. One had no response. One had a partial response. One--perhaps the most severe--had a complete remission and has been in remission for over a decade. She has had two replacement devices that she paid for herself. She has returned to a normal life after many years of being nearly bed-ridden. While the number is patients is small, the positive impact on one of three patients

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Meyer, David Organization: No
Date: 12/13/2018
Comment:
I have followed a patient in my practice both before and after implantation of device. Before: chronic suicidal ideation. After, none. Now has chronic pain but coping well. Improvement was very gradual and took over a year to be apparent. In her case I feel VNS has been life-saving. I am an APA Lifetime Distinguished Fellow with forty years oyears of experience in the field. For hers and others sake please approve this procedure undr Medicare. Thank you. David Meyer, M.D.
Cusin, Cristina Title: Assistant Professor in Psychiatry
Organization: MGH/ Harvard Medical School
Date: 12/10/2018
Comment:

I am a clinician and researcher in the field of TRD and I have been conducting studies and clinical trials in depression using medications and devices for over 10 years. I follow clinically a large number of patients with severe TRD and I provide expert consultation for colleagues and patients.

I have two comments in regard to the proposed approval of VNS.
First, I profoundly disagree with the use of "remission". The use of “remission” in a population of patients with severe

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CARROLL, BRENDAN Title: MD
Organization: THE NEUROSCIENCE ALLIANCE, LLC
Date: 12/09/2018
Comment:
I have worked in the Federal System for 25 years.
I have used VNS for TRD.
It is very effective when other treatments do not work.
I am making comment because this is an important treatment option for patients with TRD.
Abderholden, Sue Organization: NAMI Minnesota
Date: 12/09/2018
Comment:
We urge CMS to cover VNS. We have had people contact the NAMI Minnesota office who have been helped by VNS when nothing else worked. One person turned 65 and then couldn't get the treatment that helped him be well and be a part of the community. Do not deny treatment to the people who are having such a difficult time with finding effective treatment for their depression.
Pardo, Jose Title: Professor
Organization: U Minnesota
Date: 12/04/2018
Comment:
I work in the front line of clinical medicine. As soon as VNS was FDA approved, one of my patients with very severe treatment-resistant depression underwent adjunctive implantation. It took over 1 year to stop her suicidal ideation. Whereas I was seeing her weekly to every 2 weeks because of suicide risk, I have since been seeing her every 4 months. She is now about 17 years on VNS. At around 9 years, her battery ran out and over several months she relapsed. Upon getting a new device, she

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Schoenbachler, Ben Title: Associate professor
Organization: University of louisville
Date: 12/03/2018
Comment:
Anecdotally, VNS works well for TRD, with the data probably weak due to gradual benefits accruing over a lengthy period. I personally have had three patients have life-altering benefits.
Schwartz, Thomas Date: 12/03/2018
Comment:
I appreciate that CMS will pay for a small amount of devices for a study but I suggest CMS take this one step further. The US Govt Agency FDA approved this device. CMS as a Govt Agency of the US should approve VNS for TRD whole scale. There is no other TRD treatment in the literature that can deliver a 1/6 remission rate that lasts 2+ years. If CMS can show another, better studied treatment exists, I would like to see it. Until that point I hope CMS actually increases coverage greater

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Dougherty, Darin Title: Director, Division of Neurotherapeutics
Organization: Massachusetts General Hospital/Harvard Medical School
Date: 12/03/2018
Comment:

I am director of the Division of Neurotherapeutics in the Department of Psychiatry at Massachusetts General Hospital and an Associate Professor of Psychiatry at Harvard Medical School. The Division of Neurotherapeutics encompasses all surgical and/or device-related treatments for psychiatric illness and includes electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), ablative limbic system procedures (e.g., anterior cingulotomy), and deep

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Ashton, Adam Title: M.D., Clinical Professor of Psychiatry
Organization: Jacobs School of Medicine
Date: 11/27/2018
Comment:
I have had 8 treatment resistant patients get implanted with VNS and 7 of them improved, some tremendously. I had many other patients turned away by insurers who declined to approve this intervention on the basis that their interpretation of CMS's position was that it still was experimental. These folks were the sickest of the sick, having failed almost all available meds and ECT before being implanted. Their response was remarkable. As time passed and batteries died, benefit was lost as

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Mackey, Ian Date: 11/26/2018
Comment:
As a trained clinician who specializes in Treatment Resiistant Depression (TRD) I have see VNS change the lives of the majority of the 35+ patients I treat for TRD. This translates to reduced cost of medications and especially cost of inpatient hospitalizations.
Pubillones, Manuel Title: Medical Director
Organization: Noridian Healthcare System
Date: 11/19/2018
Comment:
The draft seems excellent. Nevertheless, from the Criteria I suggest deleting the word "atypical" and including the Schizoaffective Disorder under excluded conditions.