The United States Department of Justice has reached settlements with 51 hospitals in 15 states for more than $23 million related to cardiac devices that were implanted in Medicare patients in violation of Medicare coverage requirements, the agency announced Wednesday.
These settlements represent the final stage of a nationwide investigation into the practices of hundreds of hospitals improperly billing Medicare for these devices. With these additional agreements, the Justice Department's investigation has now executed settlements with more than 500 hospitals totaling more than $280 million.
In November 2015, 457 hospitals had been ordered to pay the government more than $250 million to resolve allegations that they allowed cardiac devices to be implanted in Medicare patients who were not eligible for the procedure. At that time, the biggest hospital chain settlements were HCA, at $15.8 million; Ascension Health at $14.9 million; and Community Health Systems at $13 million.
[Also: 457 hospitals settle for $250 million over improper implantable cardioverter defibrillator surgeries]
An implantable cardioverter defibrillator is an electronic device implanted near, and connected to, the heart. It detects and treats fibrillations by delivering a shock to the heart, restoring the heart's normal rhythm. It is similar in function to an external defibrillator (often found in offices and other buildings) except that it is small enough to be implanted in a patient's chest. 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. The Centers for Medicare and Medicaid Services implemented the NCD based on clinical trials, and the guidance and testimony of cardiologists and other healthcare providers, professional cardiology societies, cardiac device manufacturers and patient advocates.
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 or 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.
[Also: Running list of notable 2016 healthcare frauds]
"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," said U.S. Attorney Wifredo A. Ferrer, of the Southern District of Florida, in a statement. "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."
Most of the settling defendants were named in a whistleblower lawsuit brought under the False Claims Act, which permits private citizens to bring lawsuits on behalf of the United States and receive a portion of the proceeds of any settlement or judgment awarded against a defendant. The lawsuit was filed in federal district court in the Southern District of Florida by Leatrice Ford Richards, a cardiac nurse and Thomas Schuhmann, a healthcare reimbursement consultant. The whistleblowers have received more than $3.5 million from the recent spate of settlements.
The settlements were the result of a coordinated effort among the Civil Division's Commercial Litigation Branch, the U.S. Attorney's Office of the Southern District of Florida and HHS-OIG's Office of Investigations and Office of Counsel to the Inspector General.
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