Questionable ICD Placements Decline Following DOJ Probe

Megan Brooks

July 05, 2018

Following the US Department of Justice (DOJ) investigation into potential overuse of implantable cardioverter defibrillators (ICDs) in Medicare patients, there was a decrease in the volume of ICDs for primary prevention and in the proportion of ICDs that did not meet federal guidelines for appropriate use, a new analysis suggests.

The decrease was evident in both Medicare and non-Medicare patients and was substantially larger in hospitals that reached settlements with the DOJ.

"We went into this study with some concerns that there may have been a profound impact of the DOJ investigation on clinical care," senior author Jeptha Curtis, MD, from the Yale School of Medicine, New Haven, Connecticut, told | Medscape Cardiology.

"What we found was that certainly there were changes in how we were caring for patients and in many ways they were positive, such that the proportion of patients who were receiving an ICD who met the coverage decision requirements increased substantially over time. I think that is good for patients, good for clinicians, and a good result for the investigation," said Curtis.

The study was published online July 3 in JAMA.

In 2010, the DOJ notified hospitals of an investigation into potential overuse of ICDs in violation of the False Claims Act. The investigation was made public in 2011. By February 2016, the DOJ concluded its investigation and reached settlements with more than 500 hospitals for over $280 million for Medicare claims not meeting the Centers for Medicare & Medicaid Services' National Coverage Determination (NCD) criteria.

Our results…suggest that, on balance, the investigation had a positive effect. Dr Jeptha Curtis


To see whether the DOJ investigation changed clinical practice, investigators performed a serial cross-sectional analysis of 300,151 initial primary prevention ICDs among Medicare beneficiaries, from January 1, 2007, through December 31, 2015, at 1809 US hospitals.

In January 2007, 25.8% of ICD implants at hospitals that settled and 22.8% of those at hospitals that did not settle did not meet NCD criteria. Over time, there were a 16.1% absolute decrease and a 62.7% relative decrease in ICDs not meeting NCD criteria at hospitals that settled with the DOJ and a 12.1% absolute and 53.2% relative decrease at hospitals that did not reach a settlement.

In the period right after the DOJ announced its investigation, the proportions of ICDs not meeting NCD criteria at all hospitals decreased significantly. However, the rate was much higher and more rapid at hospitals that reached settlements. At the end of the study, the numbers of ICDs not meeting NCD criteria were similar in both groups.

During the study period, there were an absolute decrease of 1703 ICDs and a relative decrease of 32.8% in the volume of ICDs implanted for primary prevention at hospitals that reached settlement. Hospitals that did not reach a settlement had an absolute decrease of 1495 ICDs and a relative decrease of 17.4%.

Rates of ICD implants not meeting NCD criteria also declined among non-Medicare patients at hospitals that did and did not settle with the DOJ.

There were more modest decreases or slight increases in secondary prevention ICD volume.

More Investigations to Follow

"What we were afraid we were going to see but we didn't see was that there would be clear evidence that patients who needed an ICD weren't getting it," Curtis told | Medscape Cardiology. "There were no major changes in the volume of secondary prevention devices in patients who need an ICD, so this makes us optimistic that there weren't any unintended consequences of the investigation on care of patients."

"The DOJ carries a big stick and when it gets involved, it has a lot of implications for hospitals and for clinicians, and there is a lot of fear that comes from the announcement of any investigation. Our results, at least in this case, suggest that, on balance, the investigation had a positive effect," he added.

"We really need to be careful as clinicians as to how we are delivering care. We need to be able to justify why we are implanting devices in people, why we are performing procedures that carry risks and make sure that we are documenting very clearly the rationale for decisions that we are making," he said.

"I think we will be seeing more of these types of investigations both in cardiology and across medicine in years to come," Curtis predicted.

Paul Heidenreich, MD, from Stanford University School of Medicine, Palo Alto, California, agrees.

"Although the cost of these investigations to the US government is not clear, the US Department of Health and Human Services has indicated that it recovers $4 for every dollar spent investigating and enforcing fraud claims. For fiscal year 2017, $2.6 billion was recovered in health care fraud prevention activities," he notes in an accompanying editorial

"With big data available to an increasing number of analysts, sizable financial incentives, and growing reliance on appropriate use criterion, more whistle-blower complaints may be anticipated. However, physicians and hospitals can lead (rather than be chased) by developing appropriate use criteria and participating in registries tracking appropriate care," writes Heidenreich.

The study was supported by a grant from the Agency for Healthcare Research and Quality and by the National Cardiovascular Data Registry (NCDR). Curtis reports receiving salary support from the Centers for Medicare & Medicaid Services and the NCDR and having equity interest in Medtronic. Heidenreich has disclosed no relevant financial relationships.

JAMA. 2018;320:63-71, 40-42.  Full text, Editorial

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