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Wednesday, July 29, 2015

VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

From: Herbert Stein []
Sent: Wednesday, July 29, 2015 4:48 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression - “HHS/CMS we have a failure to communicate!”

Dear Madam Secretary Burwell,

I’d like to take a moment to commend and compliment Ms. Gaetana Marshall, M.S. Health Insurance Specialist out of your Atlanta, GA regional office for the time and effort she put into listening to my explanations and researching the document(s) you folks in D.C. recently sent to her office relating to my supposed issue(s) that I have been advocating to resolve these past two years.  Ms. Marshall in turn forwarded the documents (copy and pasted below) for me to read and I in turn share for everyone’s perusal.  At the same time I would also like to acknowledge the concerted efforts on the part of Ms. Courtney S. Turner, MPH - Office of Hearings and Inquiries, Medicare Ombudsman Group, Division of Medicare Ombudsman Assistance who respectfully assisted in my advocacy and has helped several of the VNS Depression patients receive medical care these past couple of years and to Ms. Stephany Terry – CMS for following up on my telephone call to Ms. Lisa Spradlin – CMS yesterday in the absence of Ms. Courtney Turner. 

I’m sure Madam Secretary that you are familiar with these famous words, “Houston, we have a problem!”  And shortly thereafter the intellectual minds at another of our government agencies, NASA, effectively, efficiently and expeditiously went to work solving a life and death crisis in a matter of days.

Well Madam Secretary I’ve come to the conclusion the same is not true for your agencies handling and effectiveness as it relates to the health care for the implanted VNS Depression patients.

In fact what I discern in this instance is “HHS/CMS we have a failure to communicate!” as well as what appears to be a classic illustration of the Tower of Babel.

In absolutely none of my advocacy/activism these past two (2) years have I advocated for approval of the VNS Therapy for Depression or the reversal of the May 4, 2007 denial.  That is the responsibility of the sponsor, Cyberonics and yet the communications I constantly receive from your agency refer me to the CMS denial decision of May 4, 2007.  Believe me I’ve carefully read that decision a number of times and I am cognizant of its contents.

What I specifically and rightfully have advocated for is care and health insurance coverage which CMS egregiously, immorally and/or unconscionably omitted or overlooked in that decision whether through ineptitude, ignorance or failure to grandfather-in-care for all the study subjects and patients implanted with this medical device prior to May 4, 2007 in accordance with the doctrine of “Continuity of care” contained in several CMS documents.

Obviously not all your subordinates understand, comprehend or obtained any message that CMS recognizes and acknowledges the medical doctrine of “Continuity of Care” as was reiterated by CMS most recent DBA adjudicated decision of December 30, 2014. These patients are rightfully to be cared for and covered by medical insurance.  The CMS decision of May 4, 2007 does not apply to these previously implanted patients.  Is that too difficult for your people to read and comprehend?

Page 62

“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)).”

Page 63

“CMS states that it “leaves decisions

regarding the maintenance of already-implanted devices to contractor discretion” and that

such decisions “are, appropriately, made on an ad hoc basis after the local contractor’s

consideration of the applicable facts.”  Id. We understand from these representations that

CMS and its contractors do not, or will not in the future, apply NCD 160.18(C) to bar

coverage of maintenance services – including replacement of the implanted VNS device

upon battery expiration – for beneficiaries who received the VNS device prior to May 4,


Yet I continue to receive communications from your agency citing the May 4, 2007 decision.  Obviously the proper communications from your office in the words of former President Regan are not having a “trickle down” effect.  For the umpteenth time please have your agency and your subordinates notify MAC, Regional Agencies, State Agencies, contractors etc., etc. that based upon the reaffirmation of the DBA adjudicated decision of December 30, 2014 that all VNS Depression patients implanted prior to May 4, 2007 are to be covered for medical care and health insurance coverage and there should be absolutely no need for these patients to have go through an appeals process as a result of your agencies inability to communicate this fact with one another.

Why must I continue to receive communications citing denials and reference to the May 4, 2007 as was recently illustrated in a communication dated July 17, 2015 from Kristen Dixon - Health Insurance Specialist - Atlanta Division of Financial Management & Fee for Service Operations (see below) and an earlier letter dated April 17, 2015 from Patrick Conway, MD, MSc - Acting Principal Deputy Administrator - Deputy Administrator for Innovation and Quality – CMS Chief Medical Officer (see below).

Why not a letter, directive or whatever document you issue to your MAC agencies, Regional office agencies, State Agencies, contractors etc., etc. apprising them of the doctrine of “Continuity of Care” and the DBA adjudicated decision of December 30, 2014 favorably affecting the VNS Therapy patients for depression?  Stop all this negativity, denials, oversight and appeal non-sense being referenced to the May 4, 2007 denial decision when in fact the December 30, 2014 decision clearly indicates these medical device implanted patients have rights to medical care and health insurance coverage.

And to those private health insurance CEO’s I have also addressed and hounded you too have unjustly denied care and medical insurance coverage to these patients and similarly you should be issuing directives to your staff that these patients should be properly cared for and rightly insured.    

Take a positive approach to wellness.  Advise all your agencies and health insurance carriers that the previously implanted VNS patients for depression are rightfully entitled to medical care and coverage without need for any denials or subsequent appeals!

Lastly, I’ll also take the liberty to remind you and all those agency staffers who read this communication:




Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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From: Marshall, Gaetana (CMS/CMHPO) []
Sent: Tuesday, July 21, 2015 7:59 AM
To: Herbert Stein (
Subject: C1502484607 Re. Mr. H. Stein

Good morning Mr. Stein,

Since our telephone conversation on Friday I have had an opportunity to follow up from discussions we had and to speak with a few of my CMS colleagues who have responsibility for standard Medicare A/B policy decisions.  Notably, I have spoken to Courtney Turner who works with the CMS Ombudsman team and the management team for Medicare A/B policy decisions.

They have provided me with the following items for your records and information:

A. A Beneficiary Casework Call (August 2014) presentation regarding VNS coverage.

B. A Sept. 24, 2013 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to the Honorable Debbie Wasserman Schultz on behalf of your wife regarding health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

C. The CMS Ombudsman’s response from January 2015 regarding the Division of Appeal Board’s (DAB) decision.

D. The April 17, 2015 letter from the CMS Center for Clinical Standards and Quality formally responding to you (on behalf of Secretary of Health and Human Services) regarding the DAB decision.

E. A July 17, 2015 letter from the Atlanta Division of Financial Management Fee for Service Operations responding to you regarding the health insurance coverage of Vague Nerve Stimulation (VNS) for the treatment of depression.

The documents above are official CMS responses to your questions regarding Medicare Advantage plan coverage for VNS treatment for depression since MA coverage is established by standard A/B policy.  Additionally, the 2014/2015 DAB appeal decision attached upheld CMS’ policy. As such, the attached CMS letters are considered comprehensive and fully respond to questions regarding health insurance coverage of VNS for treatment of depression.

I would like to thank your patience and for the opportunity to speak with you and thank you for your advocacy regarding those suffering with depression and VNS therapy.

It was my pleasure to assist you.

Very truly,

Gaetana Marshall

Ms. Gaetana Marshall, M.S.

Health Insurance Specialist

US Department of Health and Human Services

Centers for Medicare and Medicaid Services

Division of Medicare Health Plans Operations

61 Forsyth Street, Suite 4T20

Atlanta,  Georgia  30303

Ofc:  404-562-3562

Fax: 443-380-5963


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