Nearly 500 Hospitals Pay United States More Than $250 Million to Resolve False Claims Act Allegations Related to Implantation of Cardiac Devices.
The Department of Justice has reached 70 settlements involving 457 hospitals in 43 states for more than $250 million related to cardiac devices that were implanted in Medicare patients in violation of Medicare National Coverage Determinations (NCDs). The NCD provides that ICDs generally should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. The medical purpose of a waiting period -40 days for a heart attack and 90 days for bypass/angioplasty – is to give the heart an opportunity to improve function on its own to the point that an ICD may not be necessary. The NCD expressly prohibits implantation of ICDs during these waiting periods, with certain exceptions. The Department of Justice alleged that from 2003 to 2010, each of the settling hospitals implanted ICDs during the periods prohibited by the NCD. Of note is that the relator in the case produced the evidence used by the Justice Department entirely through the examination of administrative Medicare Fee-For-Service claims.
Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Departmentâ€™s Civil Division, Department of Justice, Office of Public Affairs. (2015) Friday, October 30.