An additional 51 hospitals have settled with the Department of Justice (DOJ) over cardiac devices there were not implanted according to Medicare requirements. Over 500 hospitals total have now settled regarding the implantable cardioverter defibrillator (ICD) in violation of the national coverage determination (NCD) (see Whistleblowers rake in heart-stopping $38M in cardiac device FCA settlements, November 2, 2015).
Device and NCD. The ICD is implanted near the heart and treats abnormal, life-threatening heart rhythms by shocking the heart in a similar manner to external defibrillators. Under the NCD, established by CMS with input from cardiac specialists and other stakeholders, ICDs should usually be implanted after a significant waiting period following heart attacks, bypass surgery, or angioplasty. Considering the high costs to the Medicare program for the surgery and device, the NCD’s waiting period is designed to give the heart an opportunity to improve function naturally. The hospitals involved in the settlements implanted the devices during the waiting period, costing Medicare $25,000 per procedure.
Settlements. The settlements stemmed from a case originally brought by two whistleblowers, who have received millions of dollars from the government’s recovery. Recovery from the 51 new settlements totals over $23 million, on top of the previous recoveries under the False Claims Act (FCA) ( 31 U.S.C. §3729 et seq.) of over $250 million.
After the DOJ’s previous settlements, former HHS Inspector General and compliance expert Richard Kusserow emphasized that hospitals not yet involved should review their practices related to ICD devices to ensure compliance with the NCD. He also recommended a review of all device-related procedures to ensure that they are completed according to CMS program payment requirements.