National Coverage Analysis (NCA) Tracking Sheet

Ventricular Assist Devices for Bridge-to-Transplant and Destination Therapy

CAG-00432R

Issue

Ventricular assist devices (VADs) or left ventricular assist devices (LVADs) are mechanical blood pumps that are surgically attached to one or both intact ventricles of a damaged or weakened native heart to assist in pumping blood.

VAD coverage requirements are addressed in section 20.9 of the Medicare National Coverage Determination (NCD) Manual (Pub. 100-03) entitled National Coverage Determination (NCD) for Artificial Hearts and Related Devices. Medicare covers VADs for three indications: postcardiotomy (after open-heart surgery); bridge-to-transplant (while patients await heart transplantation) and destination therapy (for patients not eligible for heart transplantation.)

Det Norske Veritas Healthcare, Inc. (DNV) has formally requested a reconsideration of the NCD to include the DNV Mechanical Circulatory Support Certification Program as an acceptable credential for facilities qualifying under this NCD. On November 14, 2012 we convened a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting to review available evidence on the management of heart failure with the use of VADs including the role, if any, of facility VAD-specific certification. In response to this reconsideration request and the recommendations of the MEDCAC panel, CMS is opening this reconsideration. The scope of our review does not include non-durable devices that are intended for temporary in-hospital use.

National Coverage Determinations

Benefit Category

No Benefit Category

Requestor Information

Requestor Name Requestor Letter
Internal and External (Darrel J. Scott, FACHE, Senior Vice President, Regulatory & Legal Affairs, Det Norske Veritas Healthcare, Inc.) View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/07/2013
Expected NCA Completion Date
10/30/2013
Public Comment Period
02/07/2013 - 03/09/2013
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/01/2013
Proposed Decision Memo Public Comment Period
08/01/2013 - 08/30/2013
Decision Memo Released
10/30/2013
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
Roya Lotfi
Lead Medical Officers
Kimberly Smith, MD, MS

Medicare Benefit Category Determination Date

Actions Taken

February 7, 2013

CMS initiates this national coverage analysis of the use of durable VADs intended to allow discharge from the hospital such as those used for the current bridge-to-transplant and destination therapy indications. The initial 30-day public comment period begins with this posting date, and ends after 30 calendar days.

CMS is requesting public comment on the clinical evidence supporting identification of patients expected to experience improved health outcomes with VAD placement as well as healthcare team and hospital standards that optimize patient outcomes, including evidence to support the current requirement for certification of hospitals implanting VADs for destination therapy.

CMS considers all public comments, and is particularly interested in comments that include clinical studies and other scientific information that provides evidence for improvement in short and long term outcomes with the use of these devices.

Instructions on submitting public comments can be found at http://www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html. You can also submit a public comment by clicking on the highlighted word comment in the title bar at the top of this page. We strongly urge that all public comments be submitted through this website. Please do not submit personal health information in public comments. Comments with personal health information may not be posted to the website.

August 1, 2013

October 30, 2013