WakeMed to pay $6.2M to settle dispute over cardiac implants for Medicare patients

The 457 hospitals agreed to pay more than $250 million total to the government, and WakeMed's share of that will be $6.2 million.

The case started as a whistleblower lawsuit in Florida, and the government took the position that hospitals could not bill Medicare for charges related to an ICD insertion if the physician’s medical decision to insert one was based on clinical criteria not specifically listed in Medicare’s 2005 coverage guidelines or if the patient’s medical record did not contain documentation that addressed each of the Medicare criteria.

"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," Principal Deputy Assistant Attorney General Benjamin Mizer, head of the U.S. Justice Department’s Civil Division, said in a statement. "We are confident that the settlements announced today will lead to increased compliance and result in significant savings to the Medicare program while protecting patient health."

Medicare coverage for the device, which costs approximately $25,000, provides that ICDs generally 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 a 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, officials said.

The Department of Justice alleged that, from 2003 to 2010, each of the hospitals implanted ICDs during the prohibited periods.

WakeMed officials said disputed ICD claims represented less than 2 percent of the ICD implant procedures performed at WakeMed during the 10-year period. They also noted that each of the disputed claims were for ICD procedures performed by physicians who are no longer at WakeMed and were not employed by WakeMed.

"At WakeMed, quality patient care is always our highest priority. It is important to recognize all ICD patients received appropriate care as deemed medically necessary by their cardiologists,” President and Chief Executive Donald Gintzig said in a memo to employees. "With that said, we are committed to following the complex coverage guidelines developed by Medicare and have refined our documentation process to ensure compliance with applicable Medicare guidance. Since the Medicare guidelines are now 10 years old, we hope that CMS will update them to reflect clinical advances, current clinical practices and the goal of supporting patient safety."