In the June issue of Drinker Biddle’s The Pulse newsletter (link below) we reported that the United States Department of Justice (DOJ) served subpoenas on a number hospitals and health systems as part of a fraud investigation into whether hospitals billed Medicare for implantable cardioverter defibrillators (ICDs) for patients whose conditions did not satisfy coverage criteria set forth in a Centers for Medicare and Medicaid Service (CMS) National Coverage Determination (NCD). We have since learned that the DOJ sent additional contact letters during the last two weeks and the government is broadening the investigation to cover many additional hospitals.

The government appears to remain focused on whether implantation of ICDs occurred within 40 days of an acute myocardial infarction or within three months of a bypass surgery or angioplasty. For some categories of patients, the NCD purportedly does not provide for coverage for ICD implantations when they are made within those time periods. As the investigation is being conducted under the False Claims Act (FCA), those targeted by the government are at risk for significant damages under the FCA’s treble damages and civil penalties provision.

To view the June issue of The Pulse, click here.