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SCD-HeFT update

This article was originally published in The Gray Sheet

Executive Summary

CMS will "undertake a complete review of the available literature" on prophylactic implantation of ICDs in patients with poor ventricular function, including SCD-HeFT, DINAMIT, DEFINITE and COMPANION clinical trials, CMS announces March 30. The agency also will assess evidence pertaining to selection of appropriate defibrillators for specific patient populations. The review responds to 1Medtronic's March 18 request that CMS amend its ICD coverage policy to include all patients with at least one year of remaining life expectancy, documented congestive heart failure for greater than 3 months and left-ventricular function of less than 35% - the indication evaluated in the SCD-HeFT trial. Following release of CMS' ICD coverage policy in 2003, the agency agreed to revisit its coverage criteria once SCD-HeFT results were unveiled (2"The Gray Sheet" March 15, 2003, p. 3)...

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