Background: In 2010, the Department of Justice (DOJ) announced an investigation into the placement of implantable cardioverter defibrillators (ICDs) outside CMS’ National Coverage Determination (NCD). Recently, more than 500 hospitals reached settlements with the DOJ totaling $250 million. We sought to examine the potential impact of the DOJ investigation on clinical practice.
Methods: Within the NCDR ICD registry, we calculated the proportion of initial primary prevention ICDs among Medicare beneficiaries not meeting NCD criteria between January 2007 and December 2015 stratified by whether the implanting hospital eventually paid a settlement to the DOJ. To examine changes in primary and secondary prevention ICD volume, we restricted to facilities implanting at least 10 ICDs in each year of the study.
Results: A total of 331,349 ICD procedures from 1820 hospitals were included; 452 of these hospitals settled with the DOJ. Prior to announcement of the DOJ investigation in 2010, hospitals that eventually settled had significantly higher proportions of primary prevention ICDs that did not meet NCD criteria (P< 0.001, Figure left panel). Following the announcement of the DOJ investigation, the proportion of implantations not meeting NCD criteria declined at all hospitals, but the pace of decline accelerated and was significantly larger in hospitals that settled (Pint= 0.009). Over the study period, there was a 33% decline in primary prevention ICD volume at hospitals that settled with DOJ as compared with a 17% reduction at hospitals that did not settle. In contrast, the volume of secondary prevention ICDs remained relatively constant over time (Figure, right panel).
Conclusion: The proportion of primary prevention ICDs not meeting NCD criteria has declined at all hospitals. Announcement of the DOJ investigation was associated with more rapid and larger reductions at hospitals that settled without evidence of unintended consequences on secondary prevention ICDs.