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.
