DOJ Investigating ICD Claims

on Thursday, 24 February 2011. All News Items

Providers that perform implantable cardioverter-defibrillator (ICD) procedures should be aware that the Department of Justice is investigating whether claims for ICDs failed to meet the relevant Medicare national coverage determination (NCD 20.4). A recent article in the Journal of the American Medical Association (JAMA) reported the results of a study that found that 22.5% of ICD cases did not meet evidence-based criteria for this implantation. The data for the study was from the National Cardiovascular Data Registry-ICD Registry. The Medicare NCD requires that hospitals report information to this registry for the implantation of an ICD for primary prevention.

The NCD contains numerous detailed requirements, but some of the main requirements that providers are failing to meet are that the patient must not have:

  • New York Heart Association (NYHC) classification IV;
  • Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within past 3 months; or
  • Had an acute MI within the past 40 days.

We strongly encourage providers to review the complete NCD to ensure they are meeting all requirements for ICD implantation for either secondary or primary prevention.

Complete and detailed physician documentation is a key component in substantiating that the patient meets the criteria for the ICD. Hospitals should work with their physicians to ensure the physicians understand the NCD criteria and the necessary documentation required to support that the ICD implantation meets the evidence-based criteria. For example, the NCD contains this statement, “MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction;” as well as precise criteria for what satisfies the diagnosis of an acute, evolving or recent MI and for an established MI.

Other high-dollar cardiac procedures associated with NCDs may become targets of Medicare reviewers, such as recovery audit contractors (RACs) and Medicare administrative contractors (MACs). Two such procedures are pacemakers (NCD 20.8) and percutaneous transluminal angioplasty with or without carotid stent placement (NCD 20.7). Providers may want to review these NCDs and assure they are following the requirements and have adequate documentation to support that the procedures meet the necessary guidelines.

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