By Zack Buck
After more than four years of investigation, and 70 separate agreements, the Department of Justice (DOJ) announced news Friday of a massive $257 million settlement, covering a record-breaking 457 hospitals, for the alleged fraudulent placement of implantable cardioverter defibrillators (ICDs) between 2003-2010. I have previously written about the twists and turns of this particular nationwide investigation—the most prominent example of the medical necessity-based health care fraud investigations—here, here, and here.
Why ICDs initially caught the attention of the DOJ seemed to be the fact that ICDs are highly expensive—costing Medicare about $25,000 per implantation—and, following a whistleblower’s lawsuit in 2008, the DOJ commenced a review of “thousands” of ICD placements nationwide. As I have written about before, hospitals across the country—including renowned hospitals such as the Cleveland Clinic—were included in the initial review, but not all of ended up on the settlement list (a full list of settling hospitals is available here).
Although the full details of the settlement have not yet been made public, there seems to have been a difference between all of the hospitals that placed ICDs outside of Medicare’s timing guidelines and those that the DOJ felt were particularly egregious (apparently less than half of the hospitals on the original investigation list ended up as part of this settlement). This is important because it may indicate a difference—in the DOJ’s thinking—between Medicare’s coverage standard, and its “medical necessity” standard for purposes of fraud enforcement.
Unsurprisingly, the settling hospitals do not admit any wrongdoing; throughout the investigation, many of the hospitals had disputed the DOJ’s allegations that the fact that ICD placements did not comply with Medicare’s timing guidelines made the placements medically unnecessary (a spokesman for one of the settling parties noted that the investigation focused only on whether or not “hospitals complied with ‘timing requirements’ in Medicare’s coverage guidelines”). And to that point, professional organizations have recommended that Medicare’s ICD timing guidelines are outdated, creating the possibility that the clinical standard in the field has diverged from the Medicare coverage determination—with strange consequences for fraud enforcement. Nevertheless, federal prosecutors have noted that the settlements of the investigation relied on evidence-based medicine, including the results of a study conducted by researchers at Duke University that found that nearly one-fourth of ICDs placed nationwide were not medically necessary.
Notwithstanding the particulars of this investigation, the ICD story is yet another that exemplifies an aggressive era of health care fraud enforcement, one increasingly focused on clinical appropriateness and medical necessity—with jarring results for scores of hospitals and doctors nationwide.