Effective Date: May 1, 2008

Implementation Date: December 1, 2008

Medicare has issued a national coverage determination (NCD) that establishes limited coverage for artificial hearts as a bridge-to-transplantation and as destination therapy, under the coverage with evidence development (CED).

This means that Medicare will cover artificial hearts when implanted in patients enrolled in Medicare-approved clinical studies that meet all of the CED criteria listed in the MLN Matters article.

For your reference, the Agency for Healthcare Research and Quality (AHRQ) supports clinical research studies, which CMS has determined meet the standards and address the research questions listed in the MLN Matters article. Clinical studies CMS has determined meet these requirements will be listed on the CMS Web site. Coverage under CED will only apply to artificial hearts implanted in the context of one of these approved clinical studies.

MLN Matters article MM6185 addresses coding requirements for coverage of artificial hearts in clinical trials for:

Here is the link to the MLN Matters article MM6185 .