ACC EP Device Implant Registry: ICD Implantations Down Among Patients Not Meeting NCD Criteria After DOJ Investigation

There was a rapid reduction in ICDs placed among patients with a diagnosis of a recent acute myocardial infarction (AMI) or recent heart failure (HF) after a Department of Justice (DOJ) investigation investigating use of ICDs, according to a study published Oct. 7 in the Journal of Cardiac Failure.

In 2016, the DOJ concluded their investigation into ICD implantation not meeting Centers for Medicare and Medicaid Services national coverage determination (NCD) criteria. More than 500 hospitals settled with the DOJ, paying more than $280 million in settlements.

The NCD was based on trial data and professional guidance and said that ICDs generally should not be implanted in patients with a recent history of AMI (within 40 days), recent PCI or CABG (within 90 days), NYHA class IV HF symptoms without concomitant CRT, or newly diagnosed HF (within 90 days).

Paul M. Bourdillon, MD, et al., analyzed all primary prevention ICD implantations in Medicare beneficiaries submitted to ACC's EP Device Implant Registry, formerly the ICD Registry, from 2007-2015 at 1,809 hospitals. They calculated rates of in-hospital adverse events and the proportion of ICDs not meeting the four NCD criteria before and after the announcement of the DOJ investigation, stratifying their findings according to whether hospitals paid settlements or not.

Initially in 2007, 26% of cases at hospitals that ultimately settled with the DOJ and 23% of cases at hospitals that did not settle did not meet NCD criteria.

Most reductions in device use were among patients with recently diagnosed HF, falling from 15.5% in 2007 before the investigation was announced to 6.8% in 2015 for hospitals that settled with the DOJ, and from 13.5% to 7.3% for hospitals that did not settle with the DOJ. Similar drops were seen among patients with a recent AMI receiving ICDs (8.4% to 1.3% for settled; 7.4% to 1.5% for non-settled).

The results showed that patients who received an ICD but did not meet NCD criteria experienced about a 26% relative increase of in-hospital adverse events, including a 52% relative increase of in-hospital mortality (both p<0.001), after adjustment for clinical covariates in the NCDR ICD complications model.

"This study demonstrated that the DOJ investigation into ICDs not meeting NCD criteria was associated with particularly rapid reductions in the proportion of devices not meeting the NCD among patients with a recent AMI or recent diagnosis of HF," the authors conclude. The study's finding of higher in-hospital adverse events, including mortality, among patients not meeting NCD criteria "highlights the importance of continuing surveillance and quality improvement," they note.

Keywords: Centers for Medicare and Medicaid Services, U.S., Quality Improvement, Percutaneous Coronary Intervention, Medicare, Heart Failure, Myocardial Infarction, Defibrillators, Implantable, Primary Prevention, Registries, Coronary Artery Bypass, EP Device Implant Registry, National Cardiovascular Data Registries


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