Life Sciences

CMS sets new facility criteria for Ventricular Assist Device coverage

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 7, 2007

Facilities seeking to implant ventricular assist devices (VADs) for destination therapy must now get Joint Commission certification under the Disease Specific Certification Program for VADs, according to new CMS coverage criteria. Facilities that are already CMS approved have until March 27, 2009, to satisfy this new requirement, CMS announced April 13. If they don't get certified, they'll be removed from the CMS list of approved facilities.

Medicare has covered VADs for destination therapy since October 2003. Destination therapy uses VADs for patients that aren't eligible for heart transplants and need a VAD for the rest of their lives to assist their heart in pumping blood. Medicare also covers VADs as a bridge to heart transplants or to support circulation after open-heart surgery.

The National Coverage Determination for VADs for destination therapy has previously required facilities implanting the VAD get approved by CMS to do so. CMS lists those approved facilities on its Web site and says it will continuously update the site. The following pre-existing facility requirements for coverage of destination therapy VAD implants continue to apply as well:

  • The facility's VAD team must have at least one member who has implanted at least 10 artificial hearts or VADs for destination therapy or as a bridge to transplant during the past 36 months.

  • The facility must also be a member of the Interagency Registry for Mechanically Assisted Circulatory Support.

    The April 13 transmittal announcing the new facility criteria is available at on the CMS Web site. A Medlearn Matters Article is also available.

    CMS released a related transmittal on April 25 that inserted language into Chapter 6, § 70 of the Medicare Managed Care Manual to indicate that certain surgical procedures such as VAD must be performed at Medicare-approved facilities. That transmittal is available on the CMS Web site.

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