National Coverage Analysis (NCA) Tracking Sheet

Ventricular Assist Devices as Destination Therapy

CAG-00119R

Issue

On October 1, 2003 CMS began Medicare coverage of Ventricular Assist Devices for use as destination therapy (patients that require permanent mechanical cardiac support).  CMS required that patients satisfy certain clinical criteria and that facilities be separately approved by the agency to perform the procedure.  CMS created temporary facility criteria, which included a surgical volume criterion and active, continuous membership in a national, audited registry of patients, and facilities submitted applications to CMS for approval.  At that time, CMS anticipated that a third party certification program would become available and CMS would allow certified facilities to be Medicare approved.

To date, 69 facilities have been approved by Medicare, but only 61 were members in the national registry through the end of 2005.  Of those facilities reporting to the registry, only 42 reported implanting VADs as a destination therapy, and only 180 patients had been so treated through the end of 2005.  Furthermore, only 10 centers had operated on 7 or more patients needing destination therapy during the past 4 years, and these 10 centers accounted for more than half of the volume of destination therapy cases.

Based on the data analyzed from the registry, it appears that the criteria for center approval created in 2003 are inadequate or not representative of actual medical practice.  We are particularly concerned that facilities are not maintaining the volume of VAD procedures that originally qualified them for approval.

Given these concerns, we believe it is appropriate to review third party standards for VAD Destination Therapy certification.  A third party will have the ability to continuously review facilities to ensure they maintain important standards that ensure good patient outcomes.

The Joint Commission has developed certification standards for VAD destination therapy facilities under their Disease-Specific Care Certification Program. They are requesting that CMS reconsider the current NCD to allow facilities certified under this program to be CMS approved as Medicare VAD destination therapy facilities.

We are reopening this decision to re-examine the facility criteria and determine the appropriate process for selecting facilities for LVAD destination therapy.

Benefit Category

Inpatient Hospital Services
Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
07/10/2006
Expected NCA Completion Date
03/27/2007
Public Comment Period
07/10/2006 - 08/09/2006
Proposed Decision Memo Due Date
Proposed Decision Memo Released
12/27/2006
Proposed Decision Memo Public Comment Period
12/27/2006 - 01/26/2007
Decision Memo Released
03/27/2007
Comments for this NCA
View Public Comments

Contacts

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

Medicare Benefit Category Determination Date

Actions Taken

July 10, 2006

Tracking sheet posted.

The Joint Commission standards [PDF, 154KB] are posted as part of this analysis.

August 23, 2006

December 27, 2006

The proposed decision memorandum is posted and available for 30 days of public comment. The Joint Commission resubmitted their standards with modifications. The new standards are now available and can now be commented on during the next 30 days.

March 27, 2007

The final decision memorandum is posted. CMS has updated the Medicare facility criteria for currently approved hospitals and will also allow hospitals certified under the Joint Commission Disease Specific Certification Program for Ventricular Assist Devices to be Medicare approved facilities.