CardioBrief: ICD Overuse Investigation Settled

— Hospitals, haunted by DOJ investigation, settle for $250 million

MedicalToday

The specter of the federal government investigation into hospital overuse of implantable cardioverter-defibrillators (ICDs) has now finally been dismissed.

The investigation, which has haunted hospital executives and electrophysiologists since it began in 2011, was finally resolved on the day before Halloween. With a $250 million treat for the government, the hospitals have now finally managed to get the unwelcome trick-or-treaters dressed in U.S. Department of Justice (DOJ) lawyer costumes to leave their doorstep.

The DOJ Friday that 457 hospitals had agreed to pay more than $250 million to settle cases involving improper implantation of ICDs in Medicare patients in violation of Medicare coverage requirements. The settlement was widely expected, as several large hospital chains had already disclosed their terms.

"While recognizing and respecting physician judgment, the department will hold accountable hospitals and health systems for procedures performed by physicians at their facilities that fail to comply with Medicare billing rules," said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department's Civil Division.

Under current rules, ICDs should not be implanted in Medicare patients until 40 days after a heart attack and 90 days after bypass surgery or PCI. "Guided by a panel of leading cardiologists and the review of thousands of patients' charts, the extensive investigation behind the settlements was heavily influenced by evidence-based medicine," said U.S. Attorney Wifredo Ferrer of the Southern District of Florida. "In terms of the number of defendants, this is one of the largest whistleblower lawsuits in the United States and represents one of this office's most significant recoveries to date. Our office will continue to vigilantly protect the Medicare program from potential false billing claims."

The case originated with a whistleblower lawsuit in Florida filed by Leatrice Ford Richards, a registered cardiovascular nurse and Medicare-compliance and reimbursement consultant, and Thomas Schuhmann, also a Medicare-compliance and reimbursement consultant. They received more than $38 million in the settlement.