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After the U.S. Department of Justice (DOJ) announced in 2010 that it was investigating hundreds of hospitals for fraud, placements of implantable cardioverter-defibrillators (ICDs) for primary prevention that didn't meet federal standards declined sharply, researchers said.

In January 2007, the proportion of initial ICDs not meeting criteria stated in a Medicare National Coverage Determination (NCD) was 25.8% at hospitals reaching a settlement with the DOJ and 22.8% at institutions that didn't (P<0.001). From then until 2015, these rates showed relative decreases of 62.7% and 53.2%, respectively (P<0.001 for both), reported Jeptha Curtis, MD, of Center for Outcomes Research and Evaluation, Yale-New Haven Hospital in Connecticut, and colleagues.

Over the study period, there was also a 32.8% relative decrease in the overall volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% relative decrease in volume at non-settlement hospitals (P<0.001), the authors reported in the .

Meanwhile, secondary prevention ICD volumes saw more modest decreases or slight increases.

"Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (June 2010-June 2011), with larger and more rapid decreases at settlement hospitals (P=0.01)," the authors noted.

"From 2007 through 2015, the volume of primary prevention ICDs and the proportion of devices not meeting the CMS NCD criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the U.S. Department of Justice investigation," Curtis' group concluded, adding that these findings were also observed in non-Medicare patients.

The required that ICDs for primary prevention be placed 40 days after MI and 90 days following revascularization. The DOJ investigation came about when two whistleblowers claimed in 2008 that many hospitals were not waiting this long to place ICDs.

By 2015, more than 450 hospitals had paid to settle fraud claims with the DOJ.

"The initial whistle-blower complaint included many more hospitals than the final list of facilities who ultimately reached settlements. As such, the group of hospitals that did not settle likely includes facilities that were investigated," Curtis' group cautioned.

Their study was focused on some 300,000 initial primary prevention ICDs that were placed at more than 1,800 hospitals participating in the National Cardiovascular Data Registry ICD Registry.

"As a form of audit and feedback, the DOJ investigation appeared to be highly effective in changing practice. Past studies of audit and feedback show relatively modest effects on changing physician behavior, although these studies did not involve allegations of fraud with financial penalties. Clearly, the reward or penalty attached to the feedback influences clinician behavior with penalties likely more effective in promoting change," commented Paul Heidenreich, MD, MS, of Stanford University School of Medicine in Palo Alto, California, in an .

Whether there were unintended consequences as a result of the DOJ investigation remains to be seen in future research, he said, though he anticipated more whistleblower complaints due to a big data environment with "sizable financial incentives" and "growing reliance" on appropriate use criteria.

"However, physicians and hospitals can lead (rather than be chased) by developing appropriate use criteria and participating in registries tracking appropriate care," Heidenreich suggested.

The NCD was revised to put an end to the data collection requirement and to specify exceptions to waiting periods for ICD placement.