By Gene Emery

(Reuters Health) – A U.S. government investigation of allegations that doctors were implanting heart-shocking defibrillators into patients who didn’t meet federal guidelines led to a dramatic reduction in the number of implants and may have saved many patients from unnecessary surgery, researchers report in the Journal of the American Medical Association.The 2010 Department of Justice probe involved Medicare recipients, but the new research also documents a comparable drop in defibrillator usage among non-Medicare recipients.The number of unnecessary implantations prevented by the investigation is not known because “there are too many factors,” senior author Dr. Jeptha Curtis of the Yale School of Medicine in New Haven, Connecticut told Reuters Health in a telephone interview.There may have been instances where patients didn’t really need the implantable cardioverter-defibrillator they received, he said, “(but) I think that is probably the minority of cases here.”In other instances, doctors and hospitals might have inadequately documented the reasons for the implantation or failed to precisely follow the guidelines – for example, by implanting a defibrillator 39 days after a heart attack when the guidelines call for waiting at least 40 days, he said.Nonetheless, more than 500 hospitals ultimately paid the government over $270 million in penalties for implantations that failed to conform to the guidelines.The study team found that after the federal investigation was announced, the decline in implantations was dramatic.In 2007, among hospitals that were destined to reach a settlement with the government, 25.8 percent of the implanted defibrillators did not meet federal guidelines. By 2012, that rate had dropped a whopping 16.1 percentage points.For hospitals not sanctioned in the investigation, the starting rate of implantation outside the guidelines was 22.8 percent; that rate subsequently declined by 12.1 percentage points.Similar declines were seen in patients not covered by Medicare, Curtis said. “It seems like the effect of the investigation extended to all candidates for defibrillators.”The decline was not seen among patients whose hearts had already stopped once and who clearly needed an ICD as soon as possible.”Many inappropriate procedures were likely avoided,” writes Dr. Paul Heidenreich, of the Stanford University School of Medicine in California, in an accompanying editorial.The new research looked at data from 1,809 hospitals, 452 of which reached settlements with the government.Curtis said the results show that patients should be asking their doctor hard questions. “If someone offers you an invasive procedure like a defibrillator that carries with it a long term commitment, it’s important to have a very detailed discussion on the evidence of the benefit and the risk of the procedure.”He said patients can go to the website to see the types of questions they should be asking their doctor.The U.S. Department of Health and Human Services recovered $2.6 billion in all types of fraudulent claims and expenses in fiscal year 2017, representing about $4 for every dollar spent investigating allegations, Heidenreich notes.  “Given this huge investment (and return) it seems reasonable to invest more in infrastructure to accurately measure and track care,” he writes.SOURCE: JAMA, online July 3, 2018.