From the Journals

ICD use curbed in hospitals named in federal lawsuit

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Sometimes a stick works better than a carrot

The federal investigation into inappropriate use of implanted cardioverter defibrillators (ICDs) appeared to be highly effective, both in recovering costs and changing behavior at hospitals.

Even though individuals were not the focus of the investigation, many physicians sensed a new exposure to civil liability, if not criminal penalties, and felt accused of providing substandard care. Did this investigation have the intended effect of improving care?

The numbers suggest it did.

The observed decrease in use raises the question of whether appropriate ICDs were also avoided, a potential unintended consequence of the investigation. The study by Desai et al noted that ICD implantations for secondary prevention remained relatively stable during this period, suggesting that appropriate ICD use likely did not decline substantially.

The investigation also clearly showed the power of a large, financially intimidating legal action.

The mere announcement of the investigation appeared to have a large and immediate influence on prompting hospitals to limit inappropriate ICD implantation for primary prevention. As a form of audit and feedback, the Department of Justice 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.

Paul A. Heidenreich, MD, professor of cardiovascular medicine at Stanford (Calif.) University, made these comments in an accompanying editorial (JAMA. 2018; 320:40-2).



A 2005 update in Medicare reimbursement policy had a modest effect on the use of implantable cardioverter defibrillators for primary prevention, but it took a whistle-blower and a federal lawsuit to bring the numbers down substantially.

Usage dropped just slightly from 2007 to 2009, after Medicare updated its appropriate use criteria, Nihar R. Desai, MD, MPH, and his colleagues reported in JAMA. From 2010 to 2011, after the Department of Justice suit became public knowledge, the declines were significantly greater: 7.4% in hospitals that eventually settled for a total of $280 million, and 4.7% in hospitals that weren’t named in the suit.

The government launched the suit in 2010, after a whistle-blower used Medicare data to allege that many hospitals weren’t waiting the appropriate amount of time to implant an implantable cardioverter defibrillator (ICD) after a heart attack or coronary revascularization, wrote Dr. Desai of Yale University, New Haven, Conn., and his team. These procedures would have been against the 2005 Centers for Medicare & Medicaid Services National Coverage Determination (NCD), which required delaying implantation for 40 days after a heart attack and 90 days after a revascularization.

Just a year after the suit was filed, an independent investigator concluded that 22.5% of the ICDs implanted from 2006 to 2009 for primary prevention were not evidence based.

Dr. Desai and his coauthors used CMS data to examine changes in the proportion of primary-prevention ICD implantations at hospitals that eventually settled the suit, and those that did not. The study spanned 2007-2015 and comprised 1,809 U.S. hospitals in the National Cardiovascular Data Registry ICD Registry; of these, 452 hospitals that had done 99,591 procedures reached settlements.

After the steeper drops in 2010 and 2011, the number of procedures leveled off. From July 2011 to 2015, the proportions of ICDs not meeting the NCD criteria were similar and stable in both hospital settlement groups, with an annual change of −0.5% for settlement hospitals and −0.4% for nonsettlement hospitals, the team wrote.

Despite the changes, there was “persistent variation” among hospitals, with more than 14% of the primary-prevention ICDs not meeting NCD criteria at some of the worst-performing hospitals.

The decreases weren’t just in Medicare beneficiaries, though. Hospitals were rethinking this indication for ICD use in everyone, although the investigators found no evidence that the changing clinical landscape endangered the health of patients.

“The analyses of secondary prevention ICDs do not suggest that access to necessary procedures was negatively affected by the investigation. … These analyses offer some reassurance, but further research into hospital responses to the investigation could offer additional insights about possible unintended consequences,” the investigators wrote.

The study was sponsored by the Agency for Healthcare Research and Quality. Dr. Desai had no financial disclosures.

SOURCE: Desai NR et al. JAMA. 2018; 320: 63-71.

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