Failure To Publish SCD-HeFT Results By CMS Deadline Will Delay ICD Decision
This article was originally published in The Gray Sheet
Executive Summary
CMS will forego issuing a national coverage determination expanding ICD coverage, unless the SCD-HeFT trial results are published in a peer-reviewed journal prior to the Dec. 28 deadline
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ICD coverage update
CMS releases 1lists of ICD registry hypotheses and data elements in advance of its final rule, which will outline implantable defibrillator coverage registry requirements, to "allow time for the public to become familiar with the data elements and prepare for future data collection efforts." The agency originally had planned to issue a new ICD Medicare coverage policy Dec. 28, including the registry requirements. However, CMS was forced to issue a 2decision maintaining the current coverage policy because results of Medtronic's SCD-HeFT clinical trial, upon which the new decision would be based, have yet to be published in a peer-reviewed journal. The agency has pledged to open reconsideration of the policy as soon as SCD-HeFT is published (3"The Gray Sheet" Dec. 20, 2004, p. 11)...