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CMS Says 'No' to Vagus Nerve Stimulation for Depression

Caroline Cassels

May 30, 2013

                                                                                               

Medicare patients with treatment-resistant depression will not have access to vagus nerve stimulation (VNS) therapy, according to a recent decision by the Centers of Medicare and Medicaid Services (CMS).

In a company release, the VNS device manufacturer, Cyberonics, Inc., announced that the CMS had declined its request for approval and stated it was "very disappointed in the position taken by CMS that new evidence accumulated over the past 5 years and recently published in 4 peer-reviewed journals does not support reconsideration of the non-coverage decision."

"We believe the total body of evidence that began appearing in the scientific literature in 1998 presents compelling rationale for access to VNS therapy in a very ill subpopulation of Medicare beneficiaries," Cyberonics' president and CEO Dan Moore said in the company release.

"The company plans to work with other interested parties to continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy, including carefully evaluating all options for appealing this decision," Moore added.

The VNS Therapy System has been approved by the US Food and Drug Administration for the treatment of refractory epilepsy and treatment-resistant depression.

 

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Cite this article: CMS Says 'No' to Vagus Nerve Stimulation for Depression. Medscape. May 30, 2013.

http://www.medscape.com/viewarticle/805010


Listed below is my email response to the above article I sent to  Medscape:

From: Joyce and Herbert Stein [mailto: Redacted]
Sent: Friday, May 31, 2013 2:30 AM
To: 'news@medscape.net'
Subject: CMS Says 'No' to Vagus Nerve Stimulation for Depression - Caroline Cassels - May 30, 2013 

To whom it may concern, 

I previously had commented to a recent article you folks published entitled “Vagus Nerve Stimulation Effective in Resistant Depression” – Frank Lowry – May 16, 2013 regarding Dr. Conway’s significant findings as to the effectiveness of this neuro-modulation therapy.

Now your Ms. Cassels reports in her article “'No' to Vagus Nerve Stimulation for Depression” that CMS and the health insurance industry are rejecting the therapy once again.   

Here’s a very interesting and significant story and fact being overlooked by your reporters and all the news media as well as doctors and the medical profession.  The story is very unique and should be brought to the attention of all concerned including the FDA, CMS and especially any study subject considering volunteering for any medical trials. 

Those VNS study subjects for depression who volunteered and have benefited from the therapy are left in a Catch-22, financial bind and out in the cold?  CMS will not authorize payment for the therapy.  Those study subjects who have benefitted cannot obtain medical coverage from CMS and/or the health insurance carriers for the replacement of the device and/or explant.  While the previous CEO publicly stated that Cyberonics would take care of all the depression study subjects the fact is Cyberonics current management has reneged and refused to pay for the replacement of the prosthesis when the battery expires for those study subjects who wish to continue with the therapy. 

How’s that for a very costly medical conundrum for these patients?  In the infinite wisdom or actual lack thereof by the FDA, CMS and the sponsor no one really gave any thought or gives a s!!t about the patient volunteers.  Those patients benefiting from the therapy are saving CMS and the health insurance companies significant sums of money as they require little to no yearly hospitalizations as in the past and in many instances have reduced and/or eliminated costly antidepressant medications as is my spouse’s case history. 

Also please keep in mind CMS and the health insurance industry will pay for the very same therapy for epilepsy patients. 

You want a news story; well I just gave it to you.  So do something about it!  Knowing that which I do today, anyone volunteering for a medical trial is out of their minds to sign on without getting in writing a determination as to who will care for them in the event the FDA approves and CMS rejects the therapy.   

Sincerely,

Herbert Stein

 

A very, very long-time caregiver and support person to my spouse of about 50 years, who was one of the earliest study subjects continuing to benefit from VNS therapy for the past 13 years.