From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, August 16, 2013 4:22 AM
To: Daniel Moore
Subject: FW: VNS Therapy for Treatment Resistant Depression
Dear Dan,
Please forgive me for my tardy response to you as I needed some time to read and research and to respectfully respond to the contents of your email. By way of this communication I have also blind copied a number of patients, physicians and media people who I have attempted to keep in the loop and up-to-date. I would suggest they first read this communication from the bottom up to establish a chronological order of dialog.
I see the predicament Joyce and I are in as an egregious oversight by CMS, FDA and all the involved responsible for establishing the protocols for the depression studies and now causing serious consequences those VNS patients for depression benefitting from and wishing to continue the treatment. This conundrum has evolved into a two-fold issue. One is to get CMS to grandfather care or whatever terminology they’d use for all the study subjects and patients whose implants were previously paid for by Medicare/Medicaid or their health insurance carriers or Cyberonics and who benefit from this therapy and wish to continue as does my spouse Joyce. The other issue is to get Cyberonics to honor their January 18, 2006 “Lifetime Reimbursement Guarantee”.
You mentioned in your email that your position is governed by “The federal anti-kickback statue” without citing the exact regulation. Please correct me if I am wrong but I shall presume you are referring to code “42 USC § 1320a–7b”.
I’ve read through the code and getting right to the point I believe Cyberonics is intentionally misinterpreting and hiding behind this code so as not honor their guarantee. In my research and understanding I also came across the following piece of information I’d like to share with you and the other involved parties:
In short, the anti-kickback statute applies to individuals or entities that knowingly and willfully (1) receive or solicit or
(2) offer or pay remuneration (anything of value) in exchange for
or as an inducement to: (a) refer an individual for the
furnishing of services or (b) purchase or lease items, services,
or facilities paid for by Medicare/Medicaid.
The purpose of the anti-kickback statute is to protect the Medicare and Medicaid programs from increased costs and abusive practices resulting from provider decisions that are based on self-interest rather that cost, quality of care or necessity of services. The law seeks to prevent overutilization, limit cost, preserve freedom of choice and preserve competition.
http://bphc.hrsa.gov/policiesregulations/policies/pal199510.html
After reading the law and the above opinion I find I am quite capable and I would believe so too are the patients and/or their support people of selecting any number of our own facilities and physicians to re-implant their prosthesis when the devices deplete. This would then absolve Cyberonics from any accusations of collusion or any sales and marketing schemes as this would be an arms-length transaction only requiring your company to pay the patient’s bill as was “guaranteed” back on January 18, 2006. Each transaction would not increase Medicare and Medicaid costs or would there be any provider decisions. Such a transaction in no way would violate the purpose and/or intent of the statue in my opinion. I am also strongly led to believe the Cyberonics legal beagles would never have issued the document in the first place had there been any concern about violating “The federal anti-kickback statue.”
Let me also add some additional comments as it relates to the intent of the law. Your company paying the full cost of the replacement “protect the Medicare and Medicaid programs from increased costs and practices”; there are no costs to the Medicare/Medicaid program as your company would pay the full tab. Further benefiting the Medicare/Medicaid programs is the fact these patients are benefiting from the VNS Therapy for Depression which means little or no yearly multiple hospitalizations, reduction in doctor visits and quite often reduction in medications. As is the case with Joyce I don’t remember the last time she was hospitalized for depression. She hasn’t been on any anti-depressant medications for years and instead of seeing her psychiatrist when she was severely depressed, as much as once a week, she sees her doctor quarterly for evaluation and interrogation of her prosthesis. So by your company paying for Joyce’s and the other patient replacement devices and maintaining their wellness you are actually benefiting and reducing costs for hospitalizations, medications, doctor visits etc. which would otherwise accrue to Medicare/Medicaid programs as well as improving the quality of care and reducing the necessity of services. I cannot fathom this to be a violation of the statue no matter how you might try to interpret it otherwise. I am also aware of a number of patients who have resumed employment, pay income taxes, add to the gross economy of this country and who otherwise would be bedridden and on the public dole which brings me to another topic.
I am currently working on trying to obtaining an opinion from the US Department of Health and Human Services, Office of Inspector General based upon the information I presented in my opinions listed above. I wonder if Cyberonics ever presented this information in a similar manner to the OIG for their opinion? I truly cannot conceive how Cyberonics can attempt to stand behind the kickback statue in the manner in which presented your facts.
I realize and respect that Cyberonics is a public profit making organization and as CEO you are responsible for not only maintaining shareholder value but increasing that value. As you stated, “Nonetheless, we continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy.” I feel strongly that your company’s statements, conversations and/or meetings with CMS are more focused on the depression indication to promote and obtain approval for new patients and less so for the concerns of the existing VNS patients for depression who are definitely benefiting and want to continue with the therapy. CMS has now declined your indication twice but I question how strongly have you really emphasized the predicament of those patients already implanted? I did ask one of your executive employees to please supply me with the names, addresses, telephone numbers and email addresses of the CMS people and/or any others you’ve been communicating with. I do so that I might advocate and enlighten these folks on my own and present the predicament we’ve unwillingly been forced into, lacking any fault of our own. I make this request in order to garner empathy and most importantly corrective results. I was advised my request for this information had to be presented to executive management. Since you’re “the man” may I obtain your cooperation and the information I’ve requested?
Thank you for sharing the fact “that everyone at Cyberonics shares your disappointment in the position taken by CMS…” Simply put, it doesn’t do it for me and represents no consolation as I have a mission and a distinct goal to achieve but anyway thanks for the thought. While you are trying to interpret for me the intent of the January 18, 2006 press release let me remind you of several points.
Prior to the FDA decision there was a meeting of an FDA advisory panel of experts in Washington D.C. some 10 years ago to decide the fate of VNS Therapy for Depression. A number of my friends (study subjects) attended and presented their very impassioned positions and pleas. Unfortunately, I could not attend but expressed my similar thoughts knowing Joyce’s remarkable response to the therapy. Just prior to the meeting I sent a letter to the panel to be entered into the records. VNS for Depression would have died right then and there if not for these patients and their heartfelt and determined efforts and advocacy. These patients conveyed to most of the advisory panel of experts the dire need that exists for newer alternative and/or adjunctive treatments as the conventional therapies were simply ineffective, refractory as well as costly for this unique and seriously ill patient population. These VNS study subjects were finally responding after decades of numerous other failed treatments and trials and multiple yearly hospitalizations.
In retrospect had the therapy been declined at that panel meeting the FDA would have definitively declined the indication and we would not be having this dialogue today, would we? Cyberonics then would be responsible for the care of these study subjects. But it did not happen. The panel was moved and understood and recognized the dire needs of this uniquely ill patient population and voted approval and eventually the FDA approved the indication as controversial as that decision was at the time. What also happened prior to these events is that Cyberonics, the FDA, all the doctors and professionals who established the protocols for the various depression studies as well as CMS all overlooked and omitted any contingency plans for what now is our very stressful and immoral Catch-22. We have implanted devices that are therapeutic with no one willing to care, pay or giving a damn for these patients. The circumstances being what they are is certainly not acceptable to me or any reasonably minded individual and the reason I strongly crusade for the exposure of these morally unjust circumstances caused by CMS as well as Cyberonics reneging on their guarantee.
Why did you not have any of the VNS depression patients attend your recent meetings with CMS? Personally they are in my opinion far better spokes persons, each with compelling stories of their own past illness, current wellness and the benefits that have accrued over the years from the VNS therapy as well as the cost savings to Medicare/Medicaid. I certainly would have availed myself and so too others capable of presenting reasoned justifications for caring for these patients. I have much to offer by way of information, observations and empirical data that would be beneficial and cost saving to CMS as a reasonably knowledgeable and active support person of 5 decades.
What you also are missing in your own interpretation and knowledge of the January 18, 2006 document is the fact I was extremely concerned and vocal as I was becoming aware of the potential loophole for these patients. What you were not a part of were my telephone discussions and concerns that I expressed to the former CEO, Skip Cummins. It was not about getting new patient coverage but about the existing study subjects and other implanted patients, my spouse Joyce included. Skip kept reassuring me “not to worry” in each of our conversations as I stated elsewhere. I told him “not to worry” didn’t do it for me. He promised me to wait a week or two and I’d have a satisfactory answer. As it turns out what appeared to be a satisfactory answer to my concerns at the time is now anything but as Cyberonics in my opinion is attempting to move the goal posts or massage away the original intent of the document by presenting some legal-ease which in my opinion is non-sense nor the true intent of “The federal anti-kickback statue” in this instance which brings me to another point.
You stated, “We have donated devices on hundreds of occasions and, in many instances, have provided assistance with finding the surgeon and facility willing to perform the procedure.” Since I do not have access to your records or the patients I’ll simply have to take your word. Of the hundreds of devices you’ve donated how many have actually been implanted pro bono and exactly how many depression patients in total are implanted and attempting to continue the therapy?
I am aware of one patient who sought replacement, was denied by the patient’s own health insurance company, who then came to Cyberonics only to be denied a second time. In what I now consider a bargaining chip or Cyberonics counter proposal to diffuse and not honor your guarantee, the patient was offered a free device with no further assistance from Cyberonics other than a stipulation all services had to be donated or no free device. It took the patient well over a year through the patient’s own efforts and initiative to finally put the package together to obtain a replacement pro bono which would contradict your alluding to Cyberonics helping the patients.
You intimate Cyberonics would like to help…why not then publish the names of the facilities and physicians who are willing to offer their services pro bono to patients as you claim? If you’re willing to offer the device for free why not consider making it easier for the patient to begin planning to put their own packages together before their devices deplete and they’re desperate, depressed and in crisis mode? Why must the patient be forced wait to the last minute? Your company is supposed to be knowledgeable about severe depression so why not respond as if you really understand? You should have a registry of existing patients continuing with VNS for Depression. Why not reach out and find those who are benefiting and wish to continue by offering some real help before their devices are depleted? What kind of help is it that you offer when the patient is severely depressed, has no support and/or advocate and has to navigate the mystical world of health care to obtain a replacement? Your company has a Facebook presence. Why not utilize the site as a means to help these patients? Why not establish a forum for existing VNS depression patients, direct them to the site to share information and dialog to help one another? Who at your company really thinks about these patients and the challenges they face being denied health insurance coverage? Why is it I get the feeling I’m getting lip service and a PR job from your organization when your company truly can do substantially more for the existing VNS depression patients than it does with little or no extra cost to your corporation?
Make no mistake about one point. VNS Therapy has truly been remarkable for Joyce and similarly for other patients with whom I converse. I vociferously expressed this fact in writing during the two comment periods to CMS; obviously to no avail. Joyce has been depression free almost 14 continuous years. We no longer discuss depression in our home. More importantly despite a recent diagnosis and diminishing abilities as a result of PSP (Progressive Supranuclear Palsy) she still is depression free. That is why I am extremely stressed facing the depletion of her 2nd and current prosthesis which will as of January 2014 be in service 9 years. From our past experiences and experimentations she will likely nosedive quickly upon depletion and therefore my immense concerns and fervent advocacy before we are in crisis mode.
I recently learned from a study subject who partook in a 5 patient VNS Bipolar study in Texas that her doctor sends the bills for interrogation services directly to Cyberonics for payment as the Bipolar indication was never FDA approved and her insurance would not pay. Since Cyberonics is paying where is there any reference to kickback laws. I could just as easily direct the facility of my choice to send Cyberonics the bill for replacement in compliance with your “Lifetime Reimbursement Guarantee” without Cyberonics violating and kickback legislation.
In my opinion, I think Cyberonics reneging on their “Lifetime Reimbursement Guarantee” and hiding behind the subterfuge of “The federal anti-kickback statue” is a truly a sham. I will continue my crusade to get CMS to grandfather care for the existing VNS Depression patients as well as battling to have Cyberonics honor their commitments and put some of their profits into morally responsible acts having nothing to do with kickback statues. Depression has been declined by CMS. CMS won’t pay. There is no reason or justification that Cyberonics can’t fund replacements. There are no kickback statues for an indication declined by CMS which you no longer promote. Your company would be donating funds for the care of these existing patients and honoring your previously stated lifetime guarantee as the patients make their own medical decisions and choices.
To the best of my knowledge when the guarantee was issued there was also an SEC 10K filing by Cyberonics noting the event. How is it that Cyberonics never established a contingent liability for the cost of those programs? Or was the company already planning on deceiving the public to never make good on their pronouncements?
You also stated, “We appreciate your support for VNS Therapy and look forward to improving access to this important therapy.”
Yes, knowing that which I do today I do agree VNS is a potentially important treatment option to be considered with the potential of improving the lives of some very seriously ill patients. Yet your closing statement, in my opinion, is all telling in that it indicates the continued mindset of the company to obtain that indication for new patients as opposed to really helping the existing patients who are benefiting and in a predicament; now! It’s about profits and less about the small number of patients caught up in this fiasco. For your company it’s less about righting an egregious wrong and oversight but getting some kind of approval for newer patients without taking care of the ones previously implanted. I support all treatment options that have the potential to alleviate suffering and pain that I’ve seen and had to endure in Joyce and others over 5 decades. Your statement clearly differentiates your continued corporate thinking as opposed to my immediate concerns and goals; health insurance coverage for the existing VNS depression patients being denied by CMS without forethought or concern to our plight.
At the moment it is not about additional access for an FDA approved indication but for the care of existing patients, in my opinion. The access is available to new patients who wish to pay out-of-pocket. It is all about who will or will not pay for replacement, care or ex-plantation costs for study subjects and existing patients; now!
Hopefully, my crusade will be pick up some momentum through the media, legal counsel and/or government representatives who are able to recognize the injustice being perpetrated against these patients through no fault of their own by bringing pressure to bear on CMS and your organization as well. I think it time to consider changing your corporate mindset and really helping these people. It certainly could be a significant and positive PR bonanza for Cyberonics as you have easier access to the media than I and hopefully justification down the road for CMS to reconsider another application for the depression indication. It is unconscionable, aggravating and stressful to me having a spouse who volunteered for a medical study, paying for her health insurance for an FDA approved treatment and being denied health care coverage. I think it would eat at you as it does for me and others caught up in this unbelievable mess.
I would additionally hope all the medical professionals, reporters, news media and government officials who have read my petition and our dialogue do not sit by idly in silence but rather take action to correct this egregious oversight and injustice.
I thank you for being attentive to my communications and concerns by always courteously responding and for now allowing me to share your response publicly as well. As you know my intent and advocacy has always been toward endorsing education, sharing information while encouraging hope and persistence. Bringing these matters out in the open and to the forefront will encourage a better understanding of the issues, constructive participation and hopefully mutually agreeable resolution(s).
Sincerely,
Herb
Joyce and Herbert Stein
1008 Trailmore Lane
Weston, FL 33326-2816
(954) 349-8733
http://www.vnstherapy-herb.blogspot.com
http://vnstherapy.wordpress.com/
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From: Dan Moore [mailto:Dan.Moore@cyberonics.com]
Sent: Wednesday, August 14, 2013 6:31 PM
To: Joyce and Herbert Stein
Subject: RE: VNS Therapy for Treatment Resistant Depression
Herb,
No problem sharing my communication from yesterday. Thanks for asking.
Best,
Dan
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From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, August 13, 2013 11:59 AM
To: Dan Moore
Subject: RE: VNS Therapy for Treatment Resistant Depression
Dear Dan,
As always I hope this note finds you and yours all doing well.
The purpose of this email is to acknowledge receipt of your email communication to me dated Tuesday, August 13, 2013 11:50 AM.
I need some time to properly digest the contents and then respond to your communication, so I ask your indulgence. I have also attached to this communication my original email correspondence to you dated June 7, 2013 that apparently you did not receive.
It is also important for me to point out to you that as well as advocating for Joyce I am also doing so for a number of other VNS Therapy patients who are in our same predicament and who are looking toward me for information to help advocate for themselves.
Therefore I am asking your permission to share your current correspondence with me publicly on my blog sites so that all may have a better understanding of the circumstances surrounding our predicament.
Sincerely,
Herb
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NOTICE OF CONFIDENTIALITY / Disclaimer
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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.
CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.
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From: Dan Moore [mailto:Dan.Moore@cyberonics.com]
Sent: Tuesday, August 13, 2013 11:50 AM
To: Joyce and Herbert Stein
Subject: VNS Therapy for Treatment Resistant Depression
Herb,
I understand that you may have tried to contact me regarding your petition related to coverage for VNS Therapy. I am aware of the petition, but to the best of my knowledge, I have not received correspondence or a phone call from you. If that is not the case, and you have tried to contact me, I apologize for having missed it.
Let me first say that everyone at Cyberonics shares your disappointment in the position taken by CMS that the new evidence accumulated over the past five years, including papers summarizing post-approval clinical studies and published recently in four peer-reviewed journals, did not convince CMS to reconsider their 2007 non-coverage decision. As I've said publicly, we continue to believe that the total body of evidence presents a compelling rationale for access to VNS Therapy for a select group of Medicare beneficiaries and others who are experiencing treatment-resistant depression. Unfortunately, CMS thus far disagrees, significantly limiting our ability to bring this therapy to patients, including those who are currently receiving and responding to VNS Therapy. To date, we have spent more than $150 million for clinical studies, regulatory filings, and company infrastructure to support the depression indication and yet reimbursement to support this important therapy is not readily available. Nonetheless, we continue to pursue access to this important therapeutic option for patients who could benefit from VNS Therapy.
In your petition, you reference a 2006 press release announcing a program to assist study patients in the event that their third-party payers denied coverage. At that time, VNS Therapy for depression was covered by some of the Medicare regional carriers, as well as a number of third-party private payers, and we believed that coverage would continue and expand over time. The program was intended to cover those patients whose insurers denied coverage that was otherwise available to other patients with treatment-resistant depression. It was not intended to be the only source of coverage for hundreds of patients.
Another important consideration is the law. Federal law prevents Cyberonics from paying the expenses of physicians or hospitals involved in prescribing or implanting our VNS Therapy System. The federal anti-kickback statue is a criminal law designed to protect government reimbursement programs, like Medicare and Medicaid, from fraud. If Cyberonics reimburses the expenses of physicians who prescribe or implant our devices, or hospitals that purchase our devices, we risk an accusation and potential prosecution by the government that we have violated the anti-kickback statute by inducing or encouraging the sale or implantation of our devices, which are reimbursed by government programs for the epilepsy indication. For this reason, our assistance to study patients has been and will continue to be limited to the donation of devices, which provides no benefit to healthcare providers.
To provide assistance to depression study patients, while addressing our compliance obligations, we include them in our VNS Therapy Access Program (VTAP). Under VTAP, we will donate a free-of-charge VNS Therapy System to any study patient as long as a surgeon and facility will also donate their services. We have donated devices on hundreds of occasions and, in many instances, have provided assistance with finding the surgeon and facility willing to perform the procedure. This is a robust program, and we are pleased to have been able to provide this level of support to many people. We will continue to support all patients with issues accessing VNS Therapy in an ethical and legally responsible manner.
We appreciate your support for VNS Therapy and look forward to improving access to this important therapy.
Sincerely,
Dan
PS Please confirm receipt so I know the email didn’t end up in your spam.
This e-mail message may contain confidential or privileged information, including sensitive patient-related information protected by state and federal laws. If you are not the intended recipient of this message, or an authorized representative of the intended recipient, you are prohibited from reviewing, copying, or distributing this message, its attachments, or any information contained in this message. If you received this message in error, please notify the sender immediately by replying to the message and delete this message from your system.
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