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Federal Investigations of Inappropriate Device Use

By July 16, 2018Commentary

Hopefully it is now beyond controversy that physicians and other clinicians are economic animals, as we all are, and that their own financial well-being often guides treatment decisions, consciously or implicitly.  That includes prescribing drugs and medical devices when they really may not be appropriate, and of course, the drug and device companies are happy to encourage that.  Research in the Journal of the American Medical Association discusses changes in use of implantable defibrillators when the Department of Justice began investigating potential mis-prescribing.   (JAMA Article)   Implantable defibrillators have limited indications and are expensive.  Around 2010 the DOJ began investigating improper use, coincident with a study which suggested that as many as 23% of devices were prescribed inappropriately.  Ultimately DOJ settled with over 500 hospitals for $280 million.  The researchers assessed the level of apparent inappropriate use before and after the investigation was announced and also attempted to ascertain whether the investigation inhibited appropriate use as an unintended consequence.  They used the device registry as a data source.  Beginning with the 6-month period beginning January 2010 through June 2010 and looking at successive 6-month periods, the authors ascertained trends as a primary outcome.

A total of over 300,000 ICDs were implanted in Medicare beneficiaries from 2007 to 2015 and included in the study.  The hospitals that ended up settling the DOJ investigation had higher volumes, were more likely to be private and more likely to be located in the South and West.  In the first half of 2007, 26% of implants in hospitals that settled and 23% at non-settling ones, were not consistent with Medicare criteria.  By the end of the study period, that inappropriate use had declined 63% at settlement hospitals and 53% at non-settling facilities.  The inappropriate use fraction, however, did not begin to decline until the investigations had begun and then began to show a fairly rapid decline, particularly among the settling hospitals, who presumably had the highest exposure.  Even at the end of the study period, when overall inappropriate use had declined significantly, there continued to be wide variation at individual facilities, from 3.8% non-conforming use at the best hospitals to 14.3% at the worst.  There was also a particularly pronounced decline in the use of the devices for primary prevention, which was not recommended.  The trend among patients who were not Medicare beneficiaries was similar to that for those who were.

It is unfortunate that it takes criminal and civil investigations to ensure that drug and device prescribing is appropriate.  Placing physicians at some financial risk for total cost of care may be a different way to address that concern, but carries its own risk that doctors may then under-prescribe.  Doctors are pretty highly compensated as it is, so you would hope that there is a renewed sense in the profession that physicians should scrupulously examine their motives for treatment decisions to avoid any perception that they are overbroad in use because they make more money.  And this particular overuse contributed significantly to excessive health spending and created major risks to patients from both the surgery and the device.  Not a positive episode in our collective health life.

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