From: Herbert Stein [mailto:firstname.lastname@example.org]
Sent: Monday, August 25, 2014 12:55 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression – Are we really going to break the bank?
Dear Madam Secretary Burwell,
I am always trying to piece together little tidbits of information as I collaborate with another reasonably informed patient to ascertain the enormity of my advocacy for the VNS Therapy volunteer study subjects and patients implanted for depression before the CMS denial of May 4, 2007 that seek to continue with their therapy. I’ve never received any answer to this question from the sponsor, Cyberonics, when I posed the question to them. So I keep on searching and recently began to re-extrapolate some figures from the information that’s come available.
This past week I received a telephone call from a representative of CMS in which I asked were they busy helping VNS patients obtain insurance coverage. The answer was “no”. Then I quickly listened into the recording of Cyberonics financial teleconference of August 21, 2014. With the help from this other VNS patient I learned there were two (2) occasions in the teleconference when the depression indication was mentioned. One mark was at 21:30 minutes into the recording and the other at 45:30 minutes. I learned there were 28 patients implanted with VNS Therapy for Depression in Cyberonics most recent reported financial quarter and in the prior quarter only 24 patients and as I vaguely recall in the quarter before that only 16. Furthermore it was stated in this teleconference by the CEO, Mr. Daniel Moore, that they believed most all of these were “replacements”. This slow increase may well correlate to or be attributed to my advocacy as patients learn that CMS has made some informal accommodations for the Medicare/Medicaid subscribers.
So if I used a number on the high-side such as 40 replacements a quarter that would represent about 160 patients that were benefiting from the therapy who want to continue with their therapy. Therefore where I previously referred to the “enormity” of my advocacy it may simply boil down to about 160 to 200 patients who have responded to the therapy and achieved a significant degree of wellness and wish to continue.
Why continue this policy of not formally recognizing and caring for this aggrieved patient group through absolutely no fault of their own? Recognize the serious error and oversight made by CMS and rightfully correct their mistake; now.
These very, very long-time suffering depression patients have benefited from the VNS Therapy and wish to continue as well as maintain their wellness. In the long-term it is a significant financial savings to CMS and the health insurers.
Once again, please issue a formal document (i.e. “Compassionate Use”) to insure their medical care now and into the future. It is the right, humane and honorable thing to do.
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
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