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Monday, July 7, 2014

U.S. Administrative Law Judge sides with VNS Depression Patient

From: Herbert Stein []
Sent: Monday, July 07, 2014 11:59 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Cc: 'Amy Larrick, Senior Advisor to the Principal Deputy Administrator Centers for Medicare & Medicaid'; 'Chet Burrell, President & CEO CareFirst BlueCross BlueShield'; 'Courtney Turner'; 'Daniel Moore, CEO - Cyberonics'; 'Daniel Schreiner, Acting Deputy Director - Office of Public Engagement'; 'Dr. Jeffrey A. Kelman (CMS/CM)'; 'Dr. Mark Bunker'; 'Lynda M. Gyles, Executive Assistant to the Secretary - HHS'; 'Marilyn Tavenner, Administrator - CMS'; 'Stephen J. Hemsley - CEO, United Healthcare'; 'Teresa NiƱo, Director - Office of Public Engagement'; Bryan Olin, Ph.d
Subject: U.S. Administrative Law Judge sides with VNS Depression Patient

Dear Madam Secretary Burwell,

Today is somewhat of an auspicious day for me.  First, I earlier in the day quickly introduced myself to you and my purpose for hounding and asserting myself upon you and your voluminous staff.  Now I’m about to tell you once again about your “fakakta (<Yiddish origin> A person or thing who is completely crazy/fucked up” organization, CMS, which in my opinion has perpetrated criminal and immoral acts against volunteer study subjects and patients implanted with VNS Therapy for Depression by grandfathering care.

To quickly recap for you and to put this matter into perspective:

1- Numerous volunteer study subjects were enrolled in studies and implanted with a VNS pulse generator.  Leads were then run from the generator and are connected to the left vagus nerve (starting in early 1999).

2- FDA approves VNS Therapy for Depression (July 15, 2005).

3- Upon FDA approval, the sponsor of the VNS Therapy, Cyberonics is no longer responsible for patient care.

4- Additional patients obtain VNS Therapy for Depression through Medicare/Medicaid and private insurance carriers upon the FDA approval from July 15, 2005 until May 4, 2007.

5- The then CEO of Cyberonics, Skip Cummins, issues a public statement of a “Lifetime Reimbursement Guarantee” at my request and insistence after I realized the potential loophole or Catch-22 in medical coverage for the study subjects (January 18, 2006).

6- CMS issues a NCD denying coverage for VNS Therapy for Depression (May 4, 2007).

7- Cyberonics changes their position, denies care and reneges on their “Lifetime Reimbursement Guarantee” citing kickback laws which in my opinion is bull-turd.

8- Cyberonics is shown the door by CMS and denied reconsideration for the Depression indication a second time (May 30, 2013).

9- I immediately begin my advocacy to obtain medical coverage for the volunteer study subjects and patients who wish to continue with their VNS Therapy for Depression (June 3, 2013).

10-I finally obtain some reasonable results after 4 month, 24/7 at my computer writing to anyone and everyone who would listen.  I receive a number of responses from individuals within your organization and then I hear from and speak with Mr. Jonathan Blum and Ms. Amy Larrick.  I am informally assured that Ms. Larrick would handle the matter directly with any Medicare/Medicaid patients needing assistance.  The informal system benefits a number of patients but leaves a lot to be desired.

11-In the meantime, Jonathan in an off-the-record telephone conversation where I requested formal documentation assures me they are working on something.

12-Ms. Kathleen Sebelius and Mr. Jonathan Blum resign and Ms. Amy Larrick is not heard from.

13-Now I’m hounding you Madam Secretary Burwell for results; nothing but results.

So just where does this leave me today.  Well, to tell you the truth I’m chuckling and appreciative of the information, input and support I’ve received from patients and their attending physicians who I blind copy on these emails.  Today I would like to cite one such instance of the outstanding courage of Ms. Amy Lasko who despite her debilitating depressive illness and personal challenges went to bat and advocated for herself and in doing so I believe will also benefit others as she shared the following information with me.

14-Amy Lasko wins an Administrative Law Judge Appeal.

I am not an attorney but I still am capable of reading English and if one carefully reads the decision rendered by Troy Smith, U.S. Administrative Law Judge he clearly indicates the CMS decision of May 4, 2007 applies to patients seeking VNS Therapy for Depression on or after May 4, 2007.  Therefore all the volunteer study subjects and patients implanted prior to May 4, 2007 should rightfully be covered by Medicare/Medicaid and/or private health insurance carriers.

I do not know the internal workings of your bureaucracy nor the various terminologies you may use.  I am once again asking for a written document for “Compassionate Use” for all those volunteer study subjects and patients who wish to continue with VNS Therapy for Depression and who were initially implanted prior to May 4, 2007.  I would like to read written directives sent to your various state agencies as well as communications sent to the various private health insurance carriers.  Based upon Judge Smith’s ruling all those private health insurance carriers such as United Healthcare are in violation of his ruling as United Healthcare and others have denied coverage to patients implanted prior to May 4, 2007.

To the patients and physicians reading my missive you might now have something to hang your hats upon to advocate for the health of your patients.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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