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10/30/15
Peninsula Regional Medical Center (PRMC) of Salisbury, MD has entered into a settlement with the United States Department of Justice (DOJ) in connection with an industry-wide investigation including hundreds of United States hospitals. Since 2010, the DOJ has audited more than 500 hospitals and health systems, including well-established programs like Emory Healthcare, the Baptist Healthcare System, Medstar Health of Maryland and Christiana Care of Delaware to determine whether hospitals billed Medicare for implantation of implantable cardioverter defibrillators (ICDs) within a designated time period following a heart attack, coronary artery bypass graft, angioplasty or revascularization procedure.  An ICD is a device that can prevent sudden death due to a cardiac arrest by shocking the heart back into a normal rhythm. Under a Medicare coverage decision issued in 2003 and revised in 2005, Medicare does not cover ICDs implanted within 40 days of a heart attack or within 90 days of a coronary artery bypass graft or an angioplasty (balloon therapy) to widen obstructed blood passages, unless certain conditions are met, even if the patient had a medical need for the ICD to be implanted.  The Medicare coverage decision deviates from the clinical judgment of cardiologists, and as a result, Medicare does not provide coverage for medically necessary ICD implantations.  A January 2014 article in the Journal of the American College of Cardiology by leading cardiologists explained that there is a “disconnect” between Medicare coverage rules and the standard of care followed by cardiologists.[1]  Accordingly, the Government’s audits focused on whether claims were covered by Medicare and not on issues of medical necessity. “Like all hospitals, we fully coordinate and comply with multiple governmental requests and inquiries annually.  We have and will continue to do so.  PRMC believes that good clinical decision-making was exercised in the ICD cases reviewed and that everyone associated with our hospital or the care of those patients acted in the best interest of our patients and without any intent to disregard CMS regulations,” stated CB Silvia, MD, PRMC’s Vice President of Medical Affairs and Chief Medical Officer. The parties reached a settlement of the allegations to avoid the delay, uncertainty, inconvenience, and expense of protracted litigation. PRMC joins hundreds of other hospitals and health systems in asking CMS to reconcile the disconnect between CMS guidelines and appropriate medical use criteria.  “Until the time issue is resolved, clinicians and hospitals will continue to be placed in the very difficult dilemma of trying to do the ‘right thing’ for their patients while recognizing that the ‘right thing’ may not be covered by the payer or the insurer at that period in time,” added Dr. Silvia. If you would like to read more about the disconnect between the guidelines and appropriate use as identified by the American College of Cardiology, please read the study linked below. [1] Richard Fogel et al., “The Disconnect Between the Guidelines, the Appropriate Use Criteria, and Reimbursement Coverage Decisions:  the Ultimate Dilemma,” Journal of the American College of Cardiology, Vol. 63, No. 1, pgs. 12-14 (January 14, 2014). ACOC Disconnect Between Guidelines and Approporate Use Criteria