On August 30, 2012, the Department of Justice (DOJ) began emailing hospitals across the country with strict instructions to examine questionable implantable defibrillator surgeries on Medicare patients and estimate potential penalties under the False Claims Act. Prosecutors of the DOJ have been investigating for over two years as to whether or not some Medicare patients have received implanted defibrillators outside of CMS rules on when these devices can be used. Not every device that falls outside the 2005 CMS National Coverage Determination rules for preventive ICD use will be penalized.
The email states that hospitals must “self-audit and estimate damages, with the severity of penalties based on whether the hospital had medical reasons to violate CMS rules; if patient harm resulted; if the hospital had prior knowledge or a statistical pattern of non-guideline implants; and if a hospital compliance program was in place.”
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