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National Coverage Analysis (NCA) Tracking Sheet

Ventricular Assist Devices as Destination Therapy

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Issue

Ventricular assist devices (VADs) are mechanical pumps used to assist a damaged or weakened heart in pumping blood. These devices support a patient’s weakened native heart but do not replace it, unlike heart transplantation. VADs are approved by the Food and Drug Administration (FDA) when used for temporary support until the native heart recovers function or a heart transplant is performed. § 65-15 of the Medicare Coverage Issues Manual (CIM) covers these devices when used in accordance with FDA labeling, including support of circulation after cardiotomy and as a bridge to transplant for patients approved and listed for heart transplantation. Medicare does not presently cover this device as an alternative to medical management in end-stage heart failure (ESHF) patients who are not eligible for a heart transplant.

CMS has received a request to revise and update CIM § 65-15 to expand coverage for use of these devices as destination (permanent) therapy for ESHF patients who are not candidates for heart transplantation. Destination therapy means that the VAD will be used by the patient for the remainder of life. Long-term use of this device will require continuous follow-up by a multi-disciplinary medical team and extensive support systems. It will also present patients, caregivers, and families with unique environmental challenges and responsibilities. We specifically request evidence to assist us in developing parameters to ensure the most positive outcomes possible.

This request is based on evidence presented in The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH). The findings of that trial are currently under review by the FDA as the result of a manufacturer’s request to expand labeling to include use of the device as destination therapy.

National Coverage Determinations

Benefit Category

Inpatient Hospital Services
Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Eric A. Rose, MD, New York, NY N/A
James W. Long, MD, PhD, Salt Lake City, UT N/A
Leslie W. Miller, MD, Minneapolis, MN N/A
Lynne Warner Stevenson, MD, Boston, MA N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
08/09/2002
Expected NCA Completion Date
09/15/2003
Public Comment Period
09/09/2002 - N/A
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
10/01/2003

Contacts

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

Medicare Benefit Category Determination Date

Actions Taken

August 12, 2002

Tracking sheet posted.

October 30, 2002

Issue referred to the Medicare Coverage Advisory Committee (MCAC). Further details about this meeting will be announced on this website and in the Federal Register. The new due date for the decision will be 60 days following receipt of the formal MCAC recommendation.

February 3, 2003

Federal Register notice with further information regarding the MCAC panel  meeting to be held on March 12, 2003, posted on our website.

March 4, 2003

CMS summary of evidence [PDF, 355KB], the agenda, roster, and questions for the March 12, 2003, MCAC panel meeting posted on our website.

March 19, 2003

Presentations and written comments presented at the March 12, 2003, MCAC panel meeting posted on our website.

The Center for Medicare Management has determined that VADs as destination therapy fall within the Inpatient Hospital Services benefit category (section 1861 (b)(2) of the Social Security Act (the Act)), which describes supplies, appliances, and equipment furnished by the hospital, for use in the hospital, for the care and treatment of inpatients. After a VAD has been surgically implanted into the patient and when the patient is not a hospital patient, the replacement of an external part or parts may be covered under Medicare Part B within the Prosthetic Device benefit category (section 1861 (s)(8) of the Act).

May 21, 2003

MCAC meeting minutes and transcript are posted. Due date is now July 14, 2003.

July 14, 2003

The decision will be delayed 30 days to allow additional time for agency clearance. Due date is now August 13, 2003.

August 13, 2003

Completion of clearances will require the decision to be delayed an additional 30 days. Due date now September 15, 2003.

October 1, 2003

Decision Memorandum announcing our decision has been posted to our website.

October 22, 2003

NCD has been posted to our website.

October 23, 2003

A listing of approved VAD destination therapy facilities has been posted on our website.
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