The Virginian‑Pilot | February 17, 2016 | By Amir Vera
Sentara Healthcare has settled a lawsuit over allegations that cardiac devices were implanted in patients in violation of Medicare coverage requirements.
The Department of Justice in October announced that more than $250 million in settlements had been reached and that 457 hospitals were involved. At the time, the department said investigations were ongoing.
Greg Burkhart, Sentara’s chief compliance and privacy officer, confirmed Wednesday that the hospital operator settled for $2.1 million and that four local hospitals were involved in the suit: Sentara Heart Hospital in Norfolk, Sentara Leigh in Norfolk, Sentara Obici in Suffolk and Sentara Virginia Beach General.
“We respected the clinical judgment of our cardiac surgeons,” Burkhart said.
He added that Sentara has put processes in place that ensure the procedure to implant cardioverter defibrillators in patients will still be conducted based on the surgeon’s clinical judgment but Medicare will not be billed for the procedure. The implantable defibrillator is a device placed in the chest or abdomen that treats irregular heartbeats.
A news release from the office of attorney Bryan Vroon said the settlement comes after two whistleblowers in Kentucky filed a complaint in 2008 under the False Claims Act, which permits whistleblowers to bring a lawsuit on behalf of the U.S. and receive part of the proceeds of settlements.
“It’s caused a major change in compliance and how many patients undergo the procedure for this lifetime device,” Vroon said when reached Wednesday night.
The case involved implantable defibrillators, which detect life-threatening heart rhythms and treat them by shocking the heart back to a normal beat. Justice officials say hospitals were implanting them too soon after their patients’ bypass surgery, angioplasty or heart attack.
The Centers for Medicare and Medicaid Services rules say defibrillators can only be implanted 40 days after a heart attack and 90 days after bypass surgery or angioplasty. The rules, established in 2003, were crafted to give patients’ heart function time to improve to a point where a defibrillator might not be needed.