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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 []
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?



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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From: Burwell, Sylvia M. (HHS/OS) []
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


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