The final coverage decision specifies the questions that studies must address and the standards those studies must meet for Medicare coverage. In developing this policy, CMS consulted with the Agency for Healthcare Research and Quality, and both agencies believe the questions and standards meet the requirements of the Medicare statute. CMS will accept submissions from the research community about trials that may answer CMS' questions about artificial hearts. Clinical studies that are determined to meet CMS' requirements will be listed on the CMS website.
"Our policy will allow beneficiaries to access artificial heart technology while also stimulating the research community to develop further evidence about the impact of this technology on improving patient outcomes," Weems said.

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The final coverage policy issued today follows a proposed decision issued in February 2008. Public comments received in response to the proposed decision were generally supportive of this decision. The final decision memorandum is available on the CMS Web site at http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=211.
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