The U.S. Department of Justice (DOJ) has shown interest in potential fraud linked to hospitals billing Medicare for implantable cardioverter defibrillators (ICD). Last year, the DOJ issued civil investigative demands on a number of hospitals, investigating whether ICDs were furnished to patients whose conditions did not satisfy the coverage indications published by CMS in a National Coverage Determination (NCD). The DOJ has since broadened its inquiry to hospitals nationwide. We expect the government's concerns only to pick up steam as a recent publication in the Journal of the American Medical Association (JAMA) adds fuel to the fire.

In the JAMA article, the researchers' review -- which focused on initial primary prevention ICD implants that occurred between January 1, 2006, and June 30, 2009 -- found that 22.5 percent of patients did not meet evidence-based guidelines for the devices. Patients were classified as receiving a non-evidence-based ICD implant if they met certain criteria; for example, they had a myocardial infarction within 40 days before ICD implantation, the patient had coronary artery bypass graft surgery within three months before ICD implantation or if the patient had newly diagnosed heart failure at the time of ICD implantation.

Despite these findings, the researchers are careful to point out some of the ICD implants may have been clinically appropriate, stating, "the ultimate judgment regarding care of a particular patient must be made by the physician and the patient in light of all the circumstances presented by that patient. There are circumstances in which deviations from these guidelines are appropriate."

The American College of Cardiology (ACC) and Heart Rhythm Society (HRS) issued a statement in response to the "important study" and reiterated the importance of research and measurement tools designed to improve patient care. The statement also emphasized that "the vast majority of implanting physicians are prescribing ICDs with the confidence that they are providing the best care for their patients." ACC and HRS echo the JAMA authors in clarifying that there are clinical situations in which the guidelines do not address unique patient circumstances.