DOJ reaches $250M in settlements with 457 hospitals for improper ICD implants

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After investigating the possible misuse of implantable cardioverter defibrillators (ICDs) for five years, the Department of Justice (DOJ) announced on Oct. 30 that it had settled with 457 hospitals in 43 states for allegedly improperly implanting ICDs in Medicare patients. The 70 settlements reached were for a total of $250 million, according to the DOJ.

The DOJ said in a  news release that most of the hospitals were named in a whistleblower lawsuit under the False Claims Act. Cardiac nurse Leatrice Ford Richards and healthcare reimbursement consultant Thomas Schuhmann filed the lawsuit in the Southern District of Florida. The DOJ said Richards and Schuhmann have received more than $38 million from the settlements.

The DOJ said it would continue to investigate other hospitals and health systems. Since January 2009, it has recovered more than $26.2 billion through the False Claims Act.

“The claims resolved by these settlements are allegations only and there has been no determination of liability,” the DOJ said in a news release.

Medicare only covers ICDs for some patients and governs the coverage decisions through the National Coverage Determination (NCD), which is based on information from clinical trials, testimony from cardiologists and other providers, along with input from cardiac device manufacturers, cardiology societies and patient advocates. Medicare coverage for ICDs costs approximately $25,000 per device.

Under the NCD, ICDs should not be implanted in patients who recently suffered an MI or had heart bypass surgery or angioplasty. The NCD notes that there should be a waiting period of 40 days after an MI and 90 days after heart bypass surgery or angioplasty before implanting an ICD.

The DOJ alleged that the  457 hospitals that settled had implanted ICDs from 2003 to 2010 during the periods prohibited by the NCD.

“The settlements announced today demonstrate the Department of Justice’s commitment to protect Medicare dollars and federal health benefits,” U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida said in a news release. “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. 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.”