National Coverage Analysis (NCA) Tracking Sheet

Ventricular Assist Devices as Destination Therapy

CAG-00119R2

Issue

A ventricular assist device (VAD) or left ventricular assist device (LVAD) is surgically attached to one or both intact ventricles and is used to assist a damaged or weakened native heart in pumping blood. Medicare currently covers these devices for three general indications; postcardiotomy, bridge to transplantation and destination therapy. Destination therapy is for patients who are not candidates for heart transplantation and require permanent mechanical cardiac support.

Coverage for destination therapy is currently restricted based on patient selection criteria including New York Heart Association class, time on optimal medical management, left ventricular ejection fraction and peak oxygen consumption. In addition, VADs implanted for destination therapy are only covered when performed in a hospital that is Medicare approved to provide this procedure.

Based on the outcome of a recent clinical study for the HeartMate II LVAS as well as recent FDA approval, Thoratec Corporation has requested that CMS reconsider the NCD. It is requesting coverage for an expanded destination therapy patient population including New York Heart Association class IIIB and a reduction of time on optimal medical management (45 days).

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Thoratec Corporation View Letter
N/A

Important Dates

Formal Request Accepted and Review Initiated
02/22/2010
Expected NCA Completion Date
11/17/2010
Public Comment Period
02/22/2010 - 03/24/2010
Proposed Decision Memo Due Date
Proposed Decision Memo Released
08/19/2010
Proposed Decision Memo Public Comment Period
08/19/2010 - 09/18/2010
Decision Memo Released
11/09/2010
Comments for this NCA
View Public Comments

Contacts

Lead Analysts
JoAnna Baldwin, MS
Lead Medical Officers
Madeline Ulrich, MD

Medicare Benefit Category Determination Date

Actions Taken

February 22, 2010

CMS opens the national coverage analysis and a 30-day public comment period begins.

August 19, 2010

CMS posts the proposed decision memorandum and begins a second 30-day public comment period.

November 9, 2010