More than 450 Hospitals Pay $257M to Resolve Allegations of Unapproved Cardiac Procedures

The Department of Justice announced today that it has reached 70 settlements involving 457 hospitals in 43 states for more than $250 million related to cardiac devices that were implanted in Medicare patients in violation of Medicare’s National Coverage Determination (NCD) requirements.  The NCD provides that devices known as implantable cardiac defibrillators (ICD) generally should not be implanted in patients who have recently had a heart attack or heart surgery.  The medical purpose of a waiting period is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary.  The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions.  The DOJ alleged that from 2003 to 2010, the hospitals implanted ICDs during the periods prohibited by the NCD.  The settlement resulted from a qui tam whistleblower lawsuit filed by a cardiac nurse, and a health care reimbursement consultant, who shared an award of more than $38 million from the settlements.  The DOJ said it is continuing to investigate additional hospitals.