457 hospitals (or, expressed differently, nearly 10% of all of the hospitals in the United States) have recently agreed to settlements worth more than a quarter of a billion dollars arising out of an investigation into Medicare billings for allegedly unnecessary cardiac implants known as implantable cardioverter defibrillators, or ICDs. ICDs regulate heart rhythms and cost about $25,000 per device.  Whether Medicare covers ICD implants is dependent on the National Coverage Determination (“NCD”).  The NCD states that ICDs should not be implanted in patients who recently suffered a heart attack or heart bypass surgery or angioplasty, and has set waiting periods for the procedure of 40 days after a heart attack and 90 days after a bypass or angioplasty.

All of the hospitals involved in the settlement were accused of implanting ICDs too quickly after heart attacks, bypass surgeries or angioplasties, thereby violating the NCD, which is prescribed to see if hearts heal enough on their own to make ICDs unnecessary.

There were a total of 70 settlements involving 457 hospitals.  Although the settlement ends the matter for some hospitals, others not covered by the settlement are still being investigated.  As a result of this settlement, the whistleblowers will receive more than $38 million.  The settlement is likely the largest in the history of the Southern District of Florida, a district known to be particularly active in combating health care fraud and abuse.

The settlements are a powerful reminder that quality of care issues have become an area of scrutiny for the OIG, whistleblowers, and of course the DOJ. Providers must exercise vigilance to avoid even the appearance that financial incentives, such as compensation arrangements and other performance metrics, are influencing clinical treatment decisions.  Educating financial, operational personnel and clinical personnel to the risks is an integral component of an effective compliance plan.  If questions or complaints are received reflecting a concern about how procedures are being performed they should be taken seriously and responded to promptly.