From: Joyce and Herbert Stein [mailto:firstname.lastname@example.org]
Sent: Friday, September 13, 2013 1:48 AM
To: Jonathan Blum, Deputy Administrator Director – CMS; Madam Secretary Kathleen Sebelius – HHS
Subject: Oh Herb do I dare have hope? Julie Ottaviani
10:49 PM (September 12, 2013)
Oh Herb do I dare have hope? I listened to your conversation with Jonathan and all I heard was the same old nonsense. I’ll get back to you. I received my denial letter from my insurance company Humana Advantage stating the CMS policy on coverage of patients implanted after May 2007 which doesn’t apply to me, I was implanted Jan. 12, 2006. And they also said I was denied because it was being used to diagnose which again does not apply to me because I am already implanted with 100% success for the last 7 years. When I called and questioned them they had no answer for me except that my doctor would have to call in and make a verbal appeal for medical necessity. I explained that they should be talking to me because my doctor was dead and the doctor making the request did not treat my illness for the past 15 years. Fell on deaf ears. The psychiatrist who is the partner of my doctor that passed away is Dr. Mathew Berger and quit frankly knows nothing about me. Just to fill you in Joyce’s history is severe and no one should suffer with this black cloud my suicide attempts totaled 12 and a few times my oldest son who was about 12 at the time was the person calling 911. Do you know that to this day even though I would not attempt suicide again because after being well for so long I realize the pain that it caused my family and my children, I still instinctively keep a full bottle of klonapin just in case I don’t get the battery. I swore I would never go back into the black hole of depression I would rather be dead. I mentioned my decline to Dr. Berger at my appointment on Sept. 12th and also about my conversation with you and your working with other doctor to convince CMS to pass the compassionate care issue. He did not seem to know anything about it. I feel more alone than ever. I mentioned to you in our conversation that I was going to consult my lawyer about the very issues you brought up in your telephone conversation with Blum and he told me it was pointless to file a suit against CMS it’s like banging your head against a brick wall. As I was listening to you tell Joyce’s story it was all so familiar to me, the endless medications
the ECT treatments that did more harm than good, but medicare will pay for them. It is because of too much shock therapy that I am on disability and costing the system money although a lot less since the VNS was put in. ECT wiped out most of my long term memory and damaged my short term memory. So much gone my whole lifetime. My talent and what earned me a living. I was somewhat of a child prodigy on the guitar classical. By the age of 12 my teachers told my parents they couldn’t teach me any more that I had learned everything they knew and more. So I began teaching. I planned on music being my life’s work. After the treatments I could not remember how to read a note. It was gone all gone. All I could remember were a few basic chords. I have never picked it up since that day. Hospital bills eventually ran us into bankruptcy. And when I finally got the implant in 2006 my improvement was just as quick as Joyce’s and very similar. I did get a little manic for a while but not bad it was a kind over happy manic and my very much missed Dr deSoto put it ” Your way too happy girl, we have to turn you down a notch”. Loved that man. So I’m going to be waiting to hear from you on Monday after you speak to Blum and I will be praying for a positive answer for Joyce, myself and all of us fighting this battle. Thank you for being our knight in shining armor.
11 Alexandria Drive
Blakely, Pa 18447
You have my permission to use any or all of this email in anyway you think will be useful in our fight.
What does it take to get through to all you folks that your department’s negligence and further delays are seriously harming the very folks that you should be caring for and that the multi-year wellness they’ve derived from VNS Therapy are also reducing health care costs.
After speaking with Dr. Daniel Schultz earlier in the day I’ve come to the conclusion it may well be both your “medical team” and his former so called “experts” appear to be out of touch with reality.
Today I was also reminded of my immediate thoughts and response after reading the contents of the May 4, 2007 national coverage denial document. I certainly was not happy to read the final determination. But what truly appalled me was some of the contents of which I read. Whoever composed the document, in my opinion, denigrated the physicians who practice psychiatry and the Art and Science of Psychiatry. If I were a Psychiatrist, I certainly would be appalled. There is no doubt in my mind that the authors of that document have no understanding of the difficult challenges these physicians face day in and day tending to this unique and seriously ill population of patients with whom conventional therapies are ineffective and very costly. How can these people who penned that document really have an understanding when amongst other statements they issue the below listed statement?
The well-designed, randomized controlled trial (D02) of 10 weeks (standard trial length for efficacy determination of an antidepressant medication)
failed to demonstrate statistically significantly superior outcomes greater than sham treatment (15% versus 10%, p = 0.31 (Fisher’s exact)).
“The well-designed, randomized controlled trial (D02) of 10 weeks…” sums up what little they knew and understood and what appears to continue to this very moment. Dr. Schultz in my conversation with him today cited that a study of such a short duration was a mistake from the start and doomed to failure. Amongst this and other points he, unlike his underlings, saw beyond their computer screens and as a practicing physicians he understood the need for the therapy. The study needed more time but why discuss this matter now as any reasonable minded individual knows it was a mistake. These patients for whom I advocate have not only responded but obtained long-term efficacy as you’ve read. Yet your department issued the absurd statement amongst other abominating statements.
The point being that it seems to me y’all still can’t comprehend what is being exhibited before your very eyes. Once again, 100% of these implanted patients wanting to continue this therapy are responders obtaining long-term efficacy. What can’t your “medical team” or any of you folks not comprehend or compute?
Your department issued the non-coverage statement on May 4, 2007. Now do the morally right and just thing and issue a favorable “Compassionate use” decision for all those patients implanted on or before May 4, 2007. At the same time it should put a smile on Dan Moore’s face as it will relieve Cyberonics of any responsibility or legal worry of violating “kickback statues” (joke).
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
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