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WakeMed News Releases

October 30, 2015
Nationwide investigation of ICD use impacts 457 hospitals

WakeMed Health & Hospitals’ Board of Directors has entered into a settlement agreement with the Federal Government related to implantable cardiac defibrillators (ICDs). WakeMed is one of numerous hospitals across the country that has chosen to settle with the government to avoid further costs despite the national clinical debate about whether Medicare’s guidelines have kept pace with current clinical practice. The government has made no determination of liability by WakeMed or any other hospital – meaning they did not find fraudulent conduct by WakeMed or any other hospital involved in this settlement.

The settlement arose out of a national investigation of 457 hospitals. The government contends that hospitals could not bill Medicare for hospital charges related to an ICD insertion if the physician’s medical decision to insert an ICD 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. WakeMed’s $6.2 million settlement is related to treatment of patients that received ICDs at WakeMed between the years of 2003 and 2013 and includes paying back to the government the allowable amount paid by Medicare to WakeMed for certain ICD procedures that were performed. Disputed ICD claims represented less than 2 percent of the ICD implant procedures performed at WakeMed during this 10-year period. Additionally, 100 percent of the disputed claims in the government’s sample relate to ICD procedures that were 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,” commented Donald Gintzig, WakeMed president and CEO. “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.”

This settlement agreement entered into by WakeMed and the U.S. Department of Justice is unrelated to the December 2012 settlement between WakeMed and the Federal Government pertaining to the classification of patients as inpatient or outpatient.
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