1. In this multicenter, longitudinal, serial cross-sectional analysis, there were 457 hospitals across 43 states that reached a monetary settlement with the Department of Justice (DOJ) totalling more than $250 million.
2. Following the announcement of the investigation, there were significant reductions in the number of primary implantable cardioverter-defibrillators (ICDs) placed among both settlement and non-settlement hospitals.
Evidence Rating: 2 (Good)
Study Rundown: In 2005, the Centers for Medicare and Medicaid Services (CMS) developed the National Coverage Determination (NCD) for ICD placement, which informed payment decisions for placement based on clinical evidence and resulted in a DOJ investigation regarding the overuse of ICDs that did not meet NCD coverage. As a result of the investigation, a number of hospitals reached a settlement decision with the DOJ. In this study, the impact of the DOJ investigation was surveilled. In total, there were 457 hospitals across 43 states that reached a monetary settlement with the Department of Justice totaling more than $250 million. Following the announcement, hospitals who reached a settlement with the DOJ had a statically significant reduction in the number of ICD placements that did not meet NCD criteria as compared to non-settlement hospitals. Eighteen months after the announcement, ICD placements not meeting NCD criteria were similar and stable among settlement and non-settlement hospitals. Throughout the investigation, there was an overall significant reduction in ICD procedural volume across all hospitals; however, there was a relatively larger reduction at settlement hospitals.
Though this study suggests that the DOJ investigation had a noticeable impact onICD placement, it is important to note that this study captured patients with Medicare benefit only. As hospitals are not required to submit data on non-Medicare beneficiaries, it is unknown if ICD placement was reduced in all patients. Despite this caveat, it was found that approximately 80% of hospitals report data for ICD placements on patients with any payer, and so it seems likely that this study is generalizable to both Medicare and non-Medicare beneficiaries.
In-Depth [cross-sectional analysis]: The National Cardiovascular Data Registry (NCDR) was used to determine the number of ICDs that did and did not meet NCD coverage criteria. The study cohort included a total of 300,151 primary prevention ICD placements at 1809 hospitals from January 1, 2007 to December 31, 2015 in the NCDR ICD registry. The primary outcome was the number of primary prevention ICD implantations among Medicare beneficiaries that did not meet CMS NCD criteria at each 6-month interval throughout the study period. Settlement hospitals placed a total of 99 591 primary prevention ICDs and non-settlement hospitals implanted 200 560 primary prevention ICDs. In total, there were 457 hospitals that reached a settlement with the DOJ totaling more than $250 million.
Prior to the announcement of the DOJ investigation from January 2007 through December 2009, the proportion of primary ICD placements not meeting NCD criteria was stable, and there were no differences between settlement and non-settlement hospitals (annualized change for settlement hospitals -1.1%; CI95 -1.7 to -0.5%; annualized change for non-settlement hospitals -0.4%; CI95 -1.0 to 0.2%; p = 0.10). Following the announcement of the investigation, from January 2010 to July 2011, there were significant reductions in the number of primary ICDs placed among both settlement and non-settlement hospitals; however, the rate of decline was more accelerated among settlement hospitals (annualized change for settlement hospitals -7.4%; CI95 -8.9 to -5.9%; annualized change for non-settlement hospitals -4.7%; CI95 -6.2 to -3.2%; p = 0.01). Eighteen months after the investigation was announced, the proportion of primary ICD placements that did not meet NCD criteria were again similar between settlement and non-settlement hospitals (annualized change for settlement hospitals -0.5%; CI95 -0.9 to -0.2%; annualized change for non-settlement hospitals -0.4%; CI95 -0.8 to -0.1%; p = 0.71).
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