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

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 criteria. Trends of the specific reasons for patients not meeting the NCD criteria and in-hospital outcomes for those patients are not known.

We analyzed 300,151 primary-prevention ICDs from 2007-2015 at 1809 hospitals. We calculated the rates of in-hospital adverse events and the proportion of ICDs not meeting the 4 NCD criteria before and after the announcement of the DOJ investigation, stratified by whether hospitals paid settlements to the DOJ. Most reductions in the use of devices in patients not meeting NCD criteria were in patients with recently diagnosed heart failure (15.5%-6.8% for settled; 13.5%-7.3% for nonsettled) and who had had a recent myocardial infarction (8.4%-1.3% for settled; 7.4% to 1.5% for nonsettled). Adverse-event rates were significantly higher for ICDs not meeting NCD criteria (odds ratio 1.26 for settled; P < 0.001; 1.18 for nonsettled; P = 0.001).

After the investigation, there was a rapid reduction in the placement of ICDs in patients with recent acute myocardial infarction or recent diagnosis of heart failure. Patients who did not meet NCD criteria experienced more in-hospital adverse events and higher mortality rates.