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Friday, April 24, 2015

VNS Therapy for Depression - "to hang on their individual desks and walls so that they finally get the message"

From: Herbert Stein []
Sent: Friday, April 24, 2015 2:56 AM
To: Dr. Patrick Conway - Acting Deputy Administrator for Innovation and Quality, CMS Chief Medical Officer
Cc: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director
Subject: VNS Therapy for Depression - "to hang on their individual desks and walls so that they finally get the message"

Dear Dr. Conway,

On the Internet about page of you’ll find the following quotations:


First, thank you for taking your valuable time to respond to my recent email to Madam Secretary Sylvia Burwell.  For purposes of this response I shall not at the moment address “Medicare has no jurisdiction over coverage decisions of a private insurance company.”  What I would like to address is that I have been cited and admonished in my two (2) years of advocacy and correspondence for this unique VNS Therapy depression patient population for my sometime harsh rhetoric in addressing/responding to those who work for the bureaucracy of HHS/CMS.  I therefore wish to point out that which follows may be harsh and is not a personal indictment of you.

I have spent two (2) years advocating and battling with HHS/CMS only to find out that your own agency acknowledges the doctrine of “Continuity of care” and these patients should have rightfully been attended to and cared for from the onset.  And yet, there are still obstacles being thrown in our way as evidenced by your letter whether through lack of knowledge, incompetence or bureaucratic sludge.

Please read those quotations listed above real carefully once again and then tell me the contents of your letter to me adhere to those principles.  My father-in-law, may he rest in peace, used to use spoonerisms at times to raise attention and/or get his point across.  One such spoonerism is the fact that you’ve got this matter “backasswards”.  I’m well aware of NCD of May 4, 2007, which incidentally only applies to depression patients, but you totally omit addressing your own agencies recent decision of December 30, 2014 and the doctrine of “Continuity of case as I quote:


The Aggrieved Parties suggest that NCD 160.18(C) is invalid because it does not address the needs of Medicare beneficiaries with TRD who were implanted with the VNS device and received Medicare coverage for VNS prior to the issuance of NCD 160.18(C) on May 4, 2007. Statement ¶¶ 38-43; Complaint ¶¶ 90-95. With respect to those beneficiaries, say the Aggrieved Parties, the NCD does not afford coverage for: (1) “the interrogation and calibration of a VNS therapy device implanted and deemed to be reasonable and medically necessary when implanted for TRD”; or (2) “for the replacement of the implanted pulse generator device upon battery expiration, when required[.]” AP Statement ¶ 43. According to the Aggrieved Parties, those omissions conflict with: (1) “continuity of care” standards that are “widely accepted within the medical community (i.e., a physician should not discontinue treatment that is effective for a patient)”; (2) “well-accepted medical standards of care that acknowledge that it is unsafe for beneficiaries to have an implanted medical device that is not properly calibrated, monitored, or is otherwise non-functional”; and (3) “CMS policy statements wherein CMS has recognized that continuing Medicare coverage for beneficiaries who received Medicare-covered durable medical equipment (DME) before it was non-covered ‘helps avoid disrupting the continuity of care for the beneficiaries . . . .’” Id. ¶¶ 40-42 (quoting 78 Fed. Reg. 40,836, 40,877 (July 8, 2013)).

Why any of these seriously ill depression patients must be challenged by your bureaucracy to have to file an appeal is anything but effective management in my opinion or in line with “Continuity of care” as cited in the above quotation from the December 30, 2014 decision.  Is there no one in all of your agencies with the authority or capability to issue a formal document of notification to any and all of your “local Medicare Administrative Contractors” to hang on their individual desks and walls so that they finally get the message?  These patients are to be covered by Medicare/Medicaid period.

With all due respect to you and the fact I’ve been a mental health advocate/activist and support person over a half century, your letter to me is one which I refer to as “bureaucratic speak”.  It sounds good but effectively accomplishes nothing.  How’s about also getting the message out to MAC (Medicare Appeals Council)?  So when the hospital applies for patient coverage for replacement surgery MAC can expeditiously approve the request because they would already have the “Continuity of care” decision of December 30, 2014 to guide them thereby significantly lessening the stress and anxiety on an already ill patient in line with the precepts noted early on in this message?  How’s about finally producing some effective and productive document to put these issues to bed?

The former Deputy Administrator Director, Jonathan Blum, put in place a contact individual within your organization to expedite and lessen the stress on the patient in order to obtain their replacement prosthesis.  In view of the fact that CMS acknowledges the doctrine of “Continuity of care” and the rightful medical coverage for these patients why is it seemingly so difficult to get the damn message out to your bureaucracy and get them all on the same page at the same time?  Send me a new letter telling me these issues have been resolved and then I can feel you and your agency have finally accomplished something and become effective.  Until that time I’ll consider these various replies as the normal “bureaucratic speak” that comes from DC.

Once again, thank you for taking the time to respond to my advocacy for the VNS Depression patients.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733





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