- 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 coverage requirements.
- Most of the settlements were brought under the False Claims Act by a whistleblower. The whistleblowers have received more than $38 million from the settlements.
- A list of the hospitals involved in the settlement can be found here. The claims resolved by these settlements are allegations only and there has been no determination of liability, the DOJ noted in a prepared statement.
An ICD, an electronic device implanted near and connected to the heart, detects and treats fibrillations by delivering a shock to the heart, restoring the heart’s normal rhythm. Only patients with certain clinical characteristics and risk factors qualify for an ICD covered by Medicare.
Medicare coverage for the device, which costs approximately $25,000, is governed by a National Coverage Determination (NCD), which provides 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 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.
This settlement illustrates the government’s emphasis on combating healthcare fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services. Since January 2009, the Justice Department has recovered a total of more than $26.2 billion through False Claims Act cases, with more than $16.4 billion of that amount recovered in cases involving fraud against federal healthcare programs.
The Department of Justice is continuing to investigate additional hospitals and health systems.