DOJ Announces $250 Million False Claims Act Settlement for Improper Cardiac Device Implantation.
The United States Department of Justice (DOJ) announced that it reached 70 settlements with 457 hospitals to resolve alleged violations of the False Claims Act (FCA) totaling $250 million. Physicians at hospitals spanning 43 states allegedly implanted cardiac devices in violation of Medicare coverage requirements. The violations largely concerned implantable cardioverter defibrillators (ICDs), a $25,000 electronic device that delivers a shock to the heart to detect and treat life-threatening heart rhythms. The DOJ claimed that from 2003 to 2010, each of the settling hospitals wrongfully implanted ICDs during waiting periods.
Only patients with certain clinical characteristics and risk factors qualify for a Medicare-covered ICD. The Centers for Medicare and Medicaid Services (CMS) implemented a National Coverage Determination (NCD) for ICDs based on clinical trials and testimony from numerous professionals. According to the NCD, patients who have recently suffered a heart attack or had heart bypass surgery or angioplasty should not receive ICDs. The NCD establishes a waiting period prior to ICD implantation, giving the heart an opportunity to improve function and potentially eliminating the need for an ICD altogether. Significantly, the NCD expressly prohibits implanting ICDs during the waiting periods, with limited exceptions.
The settlements largely originated from whistleblower lawsuits filed under the qui tam provisions of FCA, with whistleblowers receiving over $38 million in connection with the settlements. The DOJ continues to investigate additional hospitals and health systems for similar violations.
The DOJ Justice News article is available at:
The DOJ list of hospitals and settlement amounts is available at:
United States Department of Justice. “Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices.” Justice News. 30 Oct. 2015.