Trends in ICD Implantations and in-Hospital Outcomes After DOJ Investigation.

Abstract Background The Department of Justice (DOJ) investigated implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria, resulting in increased adherence to the NCD. Trends of the specific reasons for patients not meeting the NCD and in-hospital outcomes for those patients are not known. Methods We analyzed 300,151 primary prevention ICDs from 2007-2015 at 1809 hospitals. We calculated rates of in-hospital adverse events and the proportion of ICDs not meeting four NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Results Most reductions in devices not meeting NCD were among patients with recently diagnosed heart failure (15.5% to 6.8% for settled; 13.5% to 7.3% for non-settled) and with a recent myocardial infarction (8.4% to 1.3% for settled; 7.4% to 1.5% for non-settled). Adverse event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled, p Conclusions Following the investigation, there was a rapid reduction in ICDs placed for patients with a recent AMI or recent HF diagnosis. Patients who don't meet NCD criteria experienced more in-hospital adverse events and mortality.