Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Category A IDE coverage: CMS begins covering routine costs for clinical trials of Category A IDE devices, effective Jan. 1, implementing a provision in the Medicare Modernization Act of 2003, a Dec. 17 notice from the agency states. MMA stipulates that Category A devices - those for which "absolute risk" is not yet established - should be used to diagnose, monitor or treat immediately life-threatening conditions. In the Dec. 17 notice, the agency defines such conditions as "a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment." In November, AdvaMed ExecVP-Healthcare Systems & Federal Legislative Policy Carol Kelly told "The Gray Sheet" that the trade association was seeking a precise definition of "life-threatening" that specified "some reasonable period of time"...
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