MRI coverage decision
This article was originally published in The Gray Sheet
Executive Summary
CMS will allow local Medicare contractors to cover magnetic resonance imaging for measuring cardiac blood flow under a Sept. 28 1final decision. Until now, MRI for this purpose has been non-covered nationally. However, CMS is still forbidding coverage for MRI in patients who have a cardiac pacemaker. Medtronic, which is pursuing U.S. approval for its MRI-safe EnRhythm MRI SureScan pacemaker, had asked CMS to permit coverage for MRI procedures in patients with pacemakers or defibrillators that have been FDA-approved for use in an MRI environment (2"The Gray Sheet" July 6, 2009). CMS said Medtronic's request was "premature," since no MRI-safe pacemakers or ICDs have yet received FDA approval. Medtronic told "The Gray Sheet" that it expects to gain approval for EnRhythm and launch it in the U.S. by October 2010