As previously reported in Health Headlines, the United States Department of Justice (DOJ) a year ago initiated a civil investigation into hospital billing for ICDs that has continued to broaden over time, sweeping hundreds of hospitals into its net. DOJ attorneys last week served a new request for information and documents on hospitals already under the microscope, and they informed defense counsel that another wave of letters targeting new hospitals for investigation will issue shortly. To date, there have been three waves of target communications going out to hospitals, starting with Civil Investigative Demands issued in Spring 2010. So it is too early for hospitals that have implanted ICDs to breathe a sigh of relief even if they have not yet been contacted by DOJ.

The DOJ inquiry focuses on whether hospitals submitted claims for ICD implantations since October 2003 that violated a National Coverage Determination (NCD) setting forth detailed coverage criteria for the devices. Implanted under the skin and connected to the heart, an ICD monitors and corrects life-threatening, fast heart rhythm. The NCD generally disallows Medicare coverage of an ICD implanted within 40 days of an acute myocardial infarction or within three months of coronary revascularization (CABG-coronary artery bypass graft, or PTCA-percutaneous transluminal coronary angioplasty). DOJ’s inquiry focuses on claims for ICDs that appear to have been prematurely implanted based on the Department’s initial claims analysis.