The Department of Justice has inked a deal for more than $250 million with 457 hospitals across the nation — including hospitals from systems such as Franklin, Tenn.-based Community Health Systems, Nashville, Tenn.-based Hospital Corporation of America and Dallas-based Tenet Healthcare — to settle allegations related to cardiac devices that were implanted in Medicare patients in violation of Medicare coverage requirements.
The claims made against the hospitals stem from a cardiac device called an implantable cardioverter defibrillator. Only patients with certain clinical characteristics and risk factors qualify for an ICD covered by Medicare, and Medicare coverage for the device is governed by a National Coverage Determination.
The NCD provides that ICDs, which cost approximately $25,000, should not be implanted in patients who have recently suffered a heart attack or recently had heart bypass surgery or angioplasty. There is a 40-day waiting period to implant an ICD in a heart attack patient and a 90-day waiting period for bypass/angioplasty patients. During these waiting periods, the NCD expressly prohibits implantation of ICDs.
The federal government alleged each of the settling hospitals implanted ICDs during the waiting periods set by the NCD from 2003 to 2010.
Most of the hospitals that settled with the federal government were named in a qui tam, or whistle-blower, lawsuit brought under the False Claims Act. The lawsuit was filed by a cardiac nurse and a healthcare reimbursement consultant.
The DOJ is continuing to investigate additional hospitals and health systems regarding the implantation of the cardiac devices.
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