Ventricular Assist Devices as Destination Therapy

CMS NCA document | source_status=Closed | review_type=1st Recon | public_comment_open=False | document_id=CAG-00119R

The Centers for Medicare and Medicaid Services (CMS) modifies the facility criteria for Ventricular Assist Device (VAD) implantation as destination therapy as follows: Reducing the VAD implant volume standard from 15 VADs to 10 VADs or artificial hearts implanted over a three year period either as bridge-to-transplant or as destination therapy; The facility’s VAD team must include a surgeon with the requisite volume; Changing the volume measurement period from January 1, 2001 through September 30, 2003 to a continuous 3-year period; Eliminating the requirement that the hospital must be a Medicare-approved heart transplant facility; Eliminating the opportunity for an exception to these standards; Naming the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) as the registry that satisfies the CMS reporting requirement; Requiring that facilities be approved under the “Disease-Specific Care Certification Program for Ventricular Assist Device” developed by the Joint Commission on Accreditation of Healthcare Organizations, dated February 2007, and establishing a time limit for existing facilities to complete this process; and Requiring current facilities to document their continued compliance with the current and modified requirements outlined in this NCD.