The DOJ said in a news release that most of the hospitals were named in a whistleblower lawsuit under the federal 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.
“While recognizing and respecting physician judgment, the department will hold accountable hospitals and health systems for procedures performed by physicians at their facilities that fail to comply with Medicare billing rules,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We are confident that the settlements will lead to increased compliance and result in significant savings to the Medicare program while protecting patient health.”
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,” DOJ officials said.
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 a myocardial infarction (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 settlements demonstrate the Department of Justice’s commitment to protect Medicare dollars and federal health benefits,” said U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida. “Guided by a panel of 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.”
Federal prosecutors accused the 457 hospitals that settled of implanting ICDs from 2003 to 2010 during the periods prohibited by the NCD.