CMS Budget Addresses Medicare Fraud, Beefs Up Data Infrastructure
This article was originally published in The Gray Sheet
Executive Summary
While President Obama's fiscal 2011 budget request does not seek the broad coverage expansions and Medicare reforms pursued by languishing comprehensive health care reform bills, it attempts to make progress around the edges with attention to fighting Medicare fraud and beefing up CMS
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Firm enters "tentative" agreement with the Department of Justice Nov. 4 to settle allegations of illegal off-label promotion of its Isolator cardiac ablation devices for atrial fibrillation treatment. AtriCure proposes to pay $3.8 million, plus interest, over five years and enter into a corporate integrity agreement with the HHS Office of Inspector General. However, AtriCure admits no wrongdoing. The firm's Isolator bipolar ablation system and Coolrail linear ablation device are FDA-cleared for ablating cardiac tissue during surgical procedures, but not specifically for AF. Johnson & Johnson/Biosense Webster's NaviStar ThermoCool catheters remain the only FDA-approved AF ablation catheters on the market. AtriCure was among five companies facing whistleblower lawsuits for off-label promotion of ablation catheters. Medtronic, Boston Scientific and St. Jude Medical are still under investigation, while Endoscopic Technologies settled related allegations in July for $1.4 million (1"The Gray Sheet" July 20, 2009)