Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Sunday, November 3, 2013

Moral responsibility belongs to all parties...

From: Herbert Stein []
Sent: Sunday, November 03, 2013 4:29 PM
To: Daniel Moore, CEO - Cyberonics
Subject: Moral responsibility belongs to all parties...

Dear Dan,

Now that things have calmed down I’ve had a chance to also think about and reflect on the lack of morals and the egregious nature that your company has demonstrated toward the depression patients implanted with your company’s medical device.

CMS has recognized and acted appropriately to correct their lack of grandfathering care to these very same patients as evidenced by Mr. Jonathan Blum’s decision to help insure medical coverage and care for all the implanted patients on or prior to the May 4, 2007 national decision to deny.  Yet and in my opinion your company and you as CEO have exhibited no such appropriate morals or humanist concerns.  In my opinion, you’ve treated the depression patients more as pariahs than patients and/or consumers utilizing your FDA approved medical device.

Yes, I’ve had conversation with your executives as well as patients and have learned that your representatives are now beginning to make calls on the physicians alerting them and that your nurse case managers are also aware of Mr. Blum’s – CMS recent decision benefiting the depression patients.  The fact still remains in all this time there is absent any information about the depression patients (pariahs) on both your Cyberonics Corporate website and social media site on Facebook.

The fact your company obtained FDA approval and was denied national coverage by CMS, in my opinion, was no reason to ignore your company’s moral and humanist responsibility to these patients.  The fact that your company reneged on its published statement of January 18, 2006 to promise “Lifetime Reimbursement Guarantee” to the depression study subjects is further evidence of the egregious lack of responsibility and moral character of your company not only to the study subjects but all the depression patients as well.  To add fuel to this subject of lack of moral judgment and responsibility you never replied to my retort to you that “kickback statues” which was truly a lame and irresponsible justification to not care for the study subjects, in my opinion.  As it turned out your actions or properly lack of effective action and failed second attempt at approval in May 2013 was the impetuous to start my campaign and advocacy to obtain coverage for the study subjects which then continued to grow as I received patient emails questioning “what about me”.  Finally I was able to obtain medical coverage for all the implanted patients prior to the cut-off date simply because it was a moral wrong and egregious negligent oversight not only on the part of CMS, but all those individuals at the FDA, Cyberonics etc. who established the study protocol and allowed for this egregious loophole.

I shall continue to advocate and make study subjects aware to not volunteer for any study unless they are guaranteed medical care by the sponsor up and until CMS approval.

I have a niece who works for Genentech who indicated to me this fiasco would never have been allowed by her company.  They care for their study subjects throughout and encourage patient and citizen advocacy groups.  I am aware of a couple of depression patients who advocated and were spokespersons on behalf of your company for the depression therapy and once the denial was issued by CMS not only were they dropped like a scolding iron in hand, Cyberonics did little or nothing to aid these advocates when they requested replacement surgery.  Need I say more as to the deplorable way your company has addressed this depression patient population; consumers of your product.  I have much respect for Dr. Daniel Schultz, Mr. Skip Cummins and Mr. Jonathan Blum for their understanding and moral responsibilities to do the right thing for these patients.

I have expressed numerous times my sincere admiration of your financial stewardship of Cyberonics to rescue the corporation from disaster but you, in my opinion, have failed miserably as it relates to social responsibility, humanism, morals and truly understanding the challenges of this severely ill depression population and the users of your product.  Your offering a free prosthesis to these patients so long as they put the rest of the package together for free, in my eyes, is sadly laughable and demonstrates your truly lacking understanding of the patient population your addressing.  I strongly believe CMS change of position was not so much governed by statistics and crunching numbers in a computer but moral responsibility to do the right thing.  On the other hand I also feel strongly that Cyberonics remains focused, with tunnel vision and a corporate mentality, solely about money and has failed miserably to understand the human equation and true suffering of these patients.  Your corporation could have done a lot better than it has.

I think it time to change the corporate mindset at Cyberonics and that these existing patients should be acknowledged with the same understanding and PR as you place toward the Epilepsy community.  The fact that your sales may not be significant for the depression indication as a result of the May 4, 2007 determination should not have diminished your responsibility to the existing patients.  You’ve now obtained an unforeseen and unexpected bonus in that you won’t have to offer free devices to those depression patients benefiting from the therapy as their costs will be covered by medical insurance and in turn you’ll profit.

I mentioned it previously when I responded to your email about citing “kickback issues” that the depression indication would never had made it to the FDA had not the study subject patients themselves presented a compelling and humanistic advocacy in terms of response, efficacy and improved quality of life to the FDA panel of experts who agreed with the patients and then voted favorably.

I think it time you acknowledged the fact these patients exist and should finally be included on your corporate and social media websites.  I also think, in the future, as I have recently learned the importance, strength and impact that can be exerted by citizenry advocacy groups that your company might better learn how to utilize this asset.

As always, I wish you and yours wellness and continued success.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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