Life Sciences

Joint Commission introduces VAD certification program

Device Regulation Alert: Safety, Compliance and Reimbursement News, September 17, 2007

This month, The Joint Commission announced the launch of its certification program for hospitals seeking to implant ventricular assist devices (VADs) for destination therapy.

In the May 7 issue of Device Regulation Alert, we told you about CMS's new coverage criteria for facilities CMS requires such facilities get Joint Commission certification under the Disease Specific Certification Program for VADs. Facilities that are already CMS-approved for VAD have until March 27, 2009, to satisfy this new requirement or be removed from the CMS list of approved facilities.

In a September 4, 2007, press release, the Joint Commission indicated it will conduct on-site reviews of organizations seeking the VAD certification. Successful applicants will receive "a certificate of distinction under The Joint Commission's Disease-Specific Care (DSC) Program for Ventricular Assist Device." The required standards that organizations must meet cover "program management, delivering or facilitating care; performance measurement; supporting self management; clinical information systems; and VAD-specific requirements."

Medicare has covered VADs for destination therapy since October 2003. CMS's National Coverage Determination for VADs for destination therapy previously required facilities implanting the VAD receive approval from CMS to do so. VADs for destination therapy assist the heart in pumping blood for patients not eligible for heart transplants. Medicare also covers VADs as a bridge to heart transplants or to support circulation after open-heart surgery.

Click here to read CMS's April 13 transmittal announcing the new facility criteria requiring Joint Commission certification. Click here to read The Joint Commission's news release.

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