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

Friday, January 30, 2015

electroCore’s non-invasive vagus nerve stimulation therapy safe, effective across a variety of conditions

electroCore’s non-invasive vagus nerve stimulation therapy safe, effective across a variety of conditions

Published on January 29, 2015 at 8:44 AM ·

Non-invasive vagus nerve stimulation (nVNS) ‘improves the safety and tolerability of
VNS making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted VNS’ according to a review in the European Journal of Neurology. The review then went on to look at the efficacy of both surgically implanted VNS and non-invasive VNS including electroCore’s gammaCore device.

Professor Stephen Silberstein of Thomas Jefferson University – one of the authors of the paper – commented:

This review confirms that nVNS is safe and effective and because there is no surgery involved and because the costs are very competitive we believe it could open up a whole variety of conditions which we have responded to vagus nerve stimulation.

Related Stories

The Cyberonics VNS implant which has a licence in North America and Europe for refractory epilepsy and depression has been implanted in more than 70,000 patients over the last twenty years and has been found to be helpful to patients with several other conditions including headache, anxiety, gastric obesity and other conditions. However because of the high cost of treatment and the involvement of a surgical procedure these conditions were never researched in depth or brought to market.

JP Errico, CEO and founder of electroCore, commented:

This paper again validates how safe and effective VNS therapy is. It also shows how our gammaCore device can eliminate the surgical side effects and still provide effective stimulation. Our extensive pre-clinical and clinical program is already demonstrating how effective this treatment is across a variety of conditions.

electroCore has developed non-invasive Vagus Nerve Stimulation (nVNS) self-administered therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders that drive disproportionately large direct and indirect costs within the healthcare system and society.

Source:

http://www.electrocoremedical.com/

http://www.news-medical.net/news/20150129/electroCoree28099s-non-invasive-vagus-nerve-stimulation-therapy-safe-effective-across-a-variety-of-conditions.aspx

Safety of a dedicated brain MRI protocol in patients with a vagus nerve stimulator.

Epilepsia. 2014 Nov;55(11):e112-5. doi: 10.1111/epi.12774. Epub 2014 Sep 19.

Safety of a dedicated brain MRI protocol in patients with a vagus nerve stimulator.

de Jonge JC1, Melis GI, Gebbink TA, de Kort GA, Leijten FS.

Author information
  • 1Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Abstract

Although implanted metallic devices constitute a relative contraindication to magnetic resonance imaging (MRI) scanning, the safety of brain imaging in a patient with a vagus nerve stimulator (VNS) is classified as "conditional," provided that specific manufacturer guidelines are followed when a transmit and receive head coil is used at 1.5 or 3.0 Tesla. The aim of this study was to evaluate the safety of performing brain MRI scans in patients with the VNS. From September 2009 until November 2011, 101 scans were requested in 73 patients with the VNS in The Netherlands. Patients were scanned according to the manufacturer's guidelines. No patient reported any side effect, discomfort, or pain during or after the MRI scan. In one patient, a lead break was detected based on device diagnostics after the MRI-scan. However, because no system diagnostics had been performed prior to MR scanning in this patient, it is unclear whether MR scanning was responsible for the lead break. The indication for most scans was epilepsy related. Twenty-six scans (26%) were part of a (new) presurgical evaluation and could probably better have been performed prior to VNS implantation. Performing brain MRI scans in patients with an implanted VNS is safe when a modified MRI protocol is followed.

Wiley Periodicals, Inc. © 2014 International League Against Epilepsy.

KEYWORDS:

Epilepsy; Magnetic resonance imaging; Patient safety; Vagus nerve stimulator

PMID:
25244102
Related citations in PubMed

See reviews...See all
[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/25244102

Sunday, January 25, 2015

RE: Response to Your January 12, 2015 Email

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Sunday, January 25, 2015 6:33 PM
To: 'Turner, Courtney (CMS/OHI)'
Cc: 'Burwell, Sylvia M. (HHS/OS)'; 'Cavanaugh, Sean (CMS/CM)'
Subject: RE: Response to Your January 12, 2015 Email

Dear Courtney,

Thank you as always for responding to my communications.  I am tardy in reply to you as we were away cruising and just returned home today.

I have been carefully following the DAB website for any announcement relating to their recent decision on VNS Therapy for Depression.  I was just trying to touch all bases in the event I may have missed and/or overlooked any issuance of a formal document.

I am, as you know, also very disappointed in that once again any wording that I’ve read so far does not encompass all the patients implanted prior to May 4, 2007.  What I’ve read appears to leave out the patients that were previously covered by private insurers (i.e. United Healthcare) who wish to continue with the therapy and that again are a moral and unconscionable oversight on the part of DAB and our voluminous government agencies.  It is as if our government bureaucracy can’t get anything right on the first go-round or the second for that matter.

As always, I wish to thank you for your outstanding efforts and help on behalf of Joyce and the other VNS patients formerly suffering Major Depressive Disorder who have been able to obtain replacement devices and care so that they may continue enjoying lives either free of depression or greatly improved mental state.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

From: Turner, Courtney (CMS/OHI) [mailto:Courtney.Turner@cms.hhs.gov]
Sent: Wednesday, January 21, 2015 10:23 AM
To: Herbert Stein
Cc: Burwell, Sylvia M. (HHS/OS); Cavanaugh, Sean (CMS/CM)
Subject: Response to Your January 12, 2015 Email

Good Morning Mr. Stein,

Happy New Year! I hope you had a nice holiday season.

Thank you for your below inquiry.  I apologize for the delayed response.  Please see the attached letter regarding your concern.

Sincerely,

Courtney

Courtney S. Turner, MPH

Office of Hearings and Inquiries

Medicare Ombudsman Group

Division of Medicare Ombudsman Assistance

Office: 410-786-4593

Confidential or Privileged:  This communication contains information intended only for the use of the individuals to whom it is addressed and may contain information that is privileged, confidential, or exempt from other disclosure under applicable law.  If you are not the intended recipient, you are notified that any disclosure, printing, copying, distribution, or use of the contents is prohibited.  If you have received this in error, please notify the sender immediately by telephone or by returning it by reply mail and then permanently delete the communication from your system.  Thank you.

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, January 12, 2015 1:47 PM
To: Turner, Courtney (CMS/OHI)
Cc: Burwell, Sylvia M. (HHS/OS); Cavanaugh, Sean (CMS/CM)
Subject: "A decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services."

Dear Courtney,

We wish you and your family a very Happy, Healthy, Peaceful and Prosperous New Year.

I would appreciate if you could help me by sending to me a copy of the document of the recent DAB decision relating to VNS Therapy or if you could cite a link containing the decision for me to download.  To date I have been unable to find the information and/or document.

The only indication of the decision is contained in the press release from Cyberonics.

As always, thank you on behalf of Joyce and the other patients for the help and the compassion you’ve shown too many of us in desperate need.  What is now left for me to accomplish is to obtain and correct the continuing oversight and denial by the insurance carriers for their private pay patients who wish to continue with the VNS Therapy for Depression who were also implanted prior to May 4, 2007.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

Monday, January 12, 2015

Message for Stephen J. Hemsley - CEO, United Healthcare

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, January 12, 2015 4:06 AM
To: Stephen J. Hemsley - CEO, United Healthcare; Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director
Subject: VNS Therapy for Depression...

Dear Mr. Hemsley,

I had to get this quick note off to you because I just received this past evening an email from a husband seeking information and help from me for his wife.  In his brief note to me he says,

“As I said earlier she had the VNS implanted and the changes in her were amazing, she went from a person unable to hold down a job to a person able to achieve anything she has attempted.  She decided she felt well enough to attempt returning to college and has since received her degree has a Registered Nurse.”

I haven’t yet made contact with the gentlemen as I didn’t read his message until a little while ago but I certainly know who to write to and who could quickly remedy this couples problems.

Maybe you didn’t read the latest news although I informed you in a previous communication. 

Cyberonics Provides Update On Departmental Appeals Board Decision Regarding Coverage Of VNS Therapy® System In Treatment-Resistant Depression

HHS and CMS are going to cover all the Medicare/Medicaid patients implanted prior to May 4, 2007.  You guys are quick to have denied coverage based upon that decision so why is it that your company is not complying with this newer decision.  Don’t you have a conscience?  Don’t you think it is the morally correct thing to do that is to take care of your insured?  Those patients wishing to continue the therapy are benefiting from the therapy by maintaining their wellness and reducing the costs to you and the other insurers.  This therapy long ago is no longer “experimental” for these people.  It is truly an effective therapy like no other.  I’m sure as CEO you’re capable and/or your voluminous staff of crunching numbers.  These patients are saving your company money.  Contrary to your hack consultant’s opinion, Dr. Amy Schneider, whose name could easily be substituted for Dr. Tim Jack in Correspondent Scott Pelley’s reporting of December 14, 2014 entitled “Denied”.  Your consultant doesn’t know what the hell she’s talking about as I’m sure she’s never examined any of these patients.  Also of interest she writes opinions on cancer treatments.  What a sad joke in my opinion and a practice Pelley rightfully exposed in his reporting.

Don’t you think it time to have some compassion and finally do the right thing and approve care and replacement therapy for your private pay patients too?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

Thursday, January 8, 2015

"...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007."

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, January 08, 2015 3:36 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services; Sean Cavanaugh, CMS - Deputy Administrator & Director
Subject: "...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007."

Dear Madam Secretary Burwell et al,

I would first like to wish you and yours and all those reading this message a very Happy, Healthy, Peaceful and Prosperous New Year and with that said it is back to business.

That is back to the business of VNS Therapy for Depression and what I consider the continuing ineptitude and oversight of our various government agencies as it relates to the study subjects and patients implanted with a beneficial medical device seeking care and replacement for those who were implanted prior to the National Coverage Determination (NCD) of May 4, 2007.

We now have another government agency Departmental Appeals Board (DAB) of the Department of Health and Human Services rendering a decision partially favorable to the Medicare/Medicaid insured but completely ignoring and/or overlooking a group of patients who are covered by private health insurance carriers who were also implanted prior to the National Coverage Determination (NCD) of May 4, 2007.

Don’t any of you folks really look into or think about the whole picture and the ramifications of your actions?  The private health insurance carriers such as United Healthcare jumped on the bandwagon of denying coverage to patients implanted prior to May 4, 2007 while also calling the therapy “experimental”.  The fact is for this unique population of patients wanting to continue their therapy it is no longer experimental but it is in fact a multi-year tried, true, beneficial and lifesaving therapy for some.

I do thank the Departmental Appeals Board for some judgmental common sense and logic in understanding there are study subjects and patients greatly benefiting from VNS Therapy for Depression as is my spouse Joyce and for finally acknowledging somewhere in writing (I have yet to read the official decision and document) that my spouse and others covered by Medicare/Medicaid could now be assured of their continued medical coverage for this therapy.  But as I intimated previously, just what does it take to convince you folks to also care for those with private insurance?  They too have been medically, immorally and irresponsibly left to their own means to find care through the negligence of your various agencies.

I simply am not knowledgeable of the inner workings of your bureaucracy and how anything gets done.  I do know “A federal judge ordered Health and Human Services Secretary Kathleen Sebelius to allow a 10-year-old girl to receive a lung transplant sooner than required.”  Your predecessor Kathleen Sebelius quickly issued a “Compassionate Use” document to insure the judge’s order was complied with. 

Why aren’t you doing the same to insure all the VNS Therapy for Depression patients implanted prior to May 4, 2007 are similarly covered for their care and replacement?

It would only take a moment of your time to insure all these study subjects and patients are rightly cared for.  Can’t you finally right the wrong and injustice perpetrated against this group and set them all back on the track to wellness?

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

---------------------------------------------------------------

NOTICE OF CONFIDENTIALITY / Disclaimer

---------------------------------------------------------------

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.

 

From: Burwell, Sylvia M. (HHS/OS) [mailto:Sylvia.Burwell@hhs.gov]
Sent: Thursday, January 08, 2015 3:37 PM
To: Herbert Stein
Subject: RE: "...CMS and its contractors will allow coverage...for beneficiaries who began receiving VNS Therapy prior to May 4, 2007. "

Thank you very much for your e-mail.  Our ability to deliver impact depends on your input.  I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review. 

This Department belongs to the American people, and what you have to say matters to all of us.   As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose sight of the fact that ultimately, you are “the boss” – and everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

Thank you again for your message.

Sylvia Burwell

Secretary

Cyberonics Provides Update On Departmental Appeals Board Decision Regarding Coverage Of VNS Therapy® System In Treatment-Resistant Depression

Cyberonics Provides Update On Departmental Appeals Board Decision Regarding Coverage Of VNS Therapy® System In Treatment-Resistant Depression

HOUSTON, Jan. 5, 2015 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced the receipt of a decision from the Departmental Appeals Board (DAB) of the Department of Health and Human Services.

The decision concludes that the record regarding the VNS Therapy System for treatment-resistant depression is complete and adequate to support the 2007 National Coverage Determination (NCD).  The Centers for Medicare & Medicaid Services (CMS) concluded in the 2007 NCD that coverage for the treatment-resistant depression indication is not reasonable and necessary.  The decision also clarifies that CMS and its contractors will allow coverage of maintenance services – including replacement of the implanted VNS Therapy device upon battery expiration – for beneficiaries who began receiving VNS Therapy prior to May 4, 2007.

"While we acknowledge the importance of clarity for beneficiaries already benefiting from VNS Therapy, we are disappointed with this decision and disagree with the position taken by CMS.  We believe that the total body of evidence presents a compelling rationale for access to the VNS Therapy System in a very ill subpopulation of Medicare beneficiaries," said Dan Moore, Cyberonics' President and Chief Executive Officer.  "The company is evaluating options for challenging the DAB decision."

About Cyberonics, Inc. and the VNS Therapy System

Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation.  The company develops and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.  The VNS Therapy System uses an implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Safe harbor statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements can be identified by the use of forward-looking terminology, including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or other similar words.  Statements contained in this press release are based on information presently available to us and assumptions that we believe to be reasonable.  We are not assuming any duty to update this information if those facts change or if we no longer believe the assumptions to be reasonable.  Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning a challenge to the DAB decision and CMS reimbursement for the treatment-resistant depression indication.  Important factors that may cause actual results to differ include, but are not limited to:  continued market acceptance of the VNS Therapy System and sales of our products; the development and satisfactory completion of clinical studies; the achievement of regulatory approval for new products, including use of the VNS Therapy System for the treatment of other indications; satisfactory completion of the post-market registry required by the U.S. Food and Drug Administration as a condition of approval for the treatment-resistant depression indication; adverse changes in coverage or reimbursement amounts by the Centers for Medicare & Medicaid Services, state Medicaid agencies and private insurers; the presence or absence of intellectual property protection and potential patent infringement claims; maintaining compliance with government regulations; product liability claims and potential litigation; reliance on single suppliers and manufacturers for certain components; the accuracy of management's estimates of future expenses and sales; the potential identification of material weaknesses in our internal controls over financial reporting; and other risks detailed from time to time in our filings with the Securities and Exchange Commission (SEC).  For a detailed discussion of these and other cautionary statements, please refer to our most recent filings with the SEC, including our Annual Report on Form 10-K for the fiscal year ended April 25, 2014, and our Quarterly Report on Form 10-Q for the fiscal quarters ended July 25, 2014 and October 24, 2014.

Additional information about Cyberonics and the VNS Therapy System is available at www.cyberonics.com

Contact information

Greg Browne, CFO
Cyberonics, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
Main:  (281) 228-7262
Fax:  (281) 218-9332
ir@cyberonics.com

SOURCE Cyberonics, Inc.

http://www.prnewswire.com/news-releases/cyberonics-provides-update-on-departmental-appeals-board-decision-regarding-coverage-of-vns-therapy-system-in-treatment-resistant-depression-300015832.html

Departmental Appeals Board (DAB)

Legal images collage

The title Departmental Appeals Board (“DAB”) refers both to the Board Members (collectively the “Board”) that the Secretary appoints and to the larger staff organization. The DAB provides impartial, independent review of disputed decisions in a wide range of Department programs under more than 60 statutory provisions.

The DAB includes the Board itself (supported by the Appellate Division), Administrative Law Judges (“ALJs”) (supported by the Civil Remedies Division), and the Medicare Appeals Council (supported by the Medicare Operations Division). Thus, the DAB has three adjudicatory divisions, each with its own set of judges and staff, as well as its own areas of jurisdiction. The DAB also has a leadership role in implementing Alternative Dispute Resolution (“ADR”) across the Department, since the DAB Chair is the designated Dispute Resolution Specialist under the Administrative Dispute Resolution Act of 1996.

DAB Divisions

Alternative Dispute Resolution Division
The Alternative Dispute Resolution Division provides alternative dispute resolution (“ADR”) services in appeals filed with the Board’s other three Divisions. ADR in Board cases typically involves either mediation or ombudsman services.

Appellate Division
The Appellate Division provides staff support for the Board Members, who are career civil servants appointed by the Secretary to provide an impartial, independent review of disputes arising in a wide range of HHS programs. The Board also provides appellate review of certain types of Administrative Law Judge decisions. In most cases, the Board decision is the final administrative decision of HHS.

Civil Remedies Division
The Civil Remedies Division (“CRD”) provides staff support for the Administrative Law Judges (“ALJs”) assigned to the DAB. The ALJs are qualified under the Federal Administrative Procedure Act to conduct hearings on the record. Generally, the ALJ decision is an initial decision that may be appealed to the Board. If the ALJ decision is not appealed, it represents the final administrative decision.

Medicare Operations Division
The Medicare Operations Division provides staff support to the Administrative Appeals Judges and Appeals Officers on the Medicare Appeals Council. The Council provides the final administrative review of claims for entitlement to Medicare and individual claims for Medicare coverage and payment filed by beneficiaries or health care providers/suppliers.

http://www.hhs.gov/dab/