On April 28, 2008, Society leaders met with Centers for Medicare & Medicaid Services (CMS) officials from the Recovery Audit Contractor (RAC) program to discuss concerns with the pilot review process for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) procedures that recently occurred in Massachusetts and New York. The Society expressed deep concern that evidence based criteria was not used during the demonstration to determine whether or not certain procedures were appropriate for inpatient admission or should have been placed in outpatient observation.

The Society also expressed concern that the auditors lacked sufficient expertise to apply guidelines and were inconsistent in their decision-making. “There are many factors that must be taken into consideration when the decision is made to perform an ICD procedure,” said Bruce D. Lindsay, MD, FHRS, Heart Rhythm Society President. “The decision to perform an ICD procedure in an inpatient versus outpatient setting depends on the physician’s assessment of the severity of disease, the acuity of illness, and the complexity of the procedures.”

Also discussed during the meeting were ways that the Society could work effectively with CMS to ensure the permanent RAC program to be implemented nationwide by January 1, 2010 uses guidelines that are transparent and do not conflict with current standards of care for ICD and CRT-D procedures.

CMS welcomed the Society’s comments and expressed a keen interest in receiving feedback on how the use of RACs may effect the safety and quality of care for patients receiving these life saving devices.

The agency also indicated for the permanent program, it would ensure that RACs adhere to Medicare policies, regulations, national or local coverage determinations and manual instructions when conducting claim reviews. The current Medicare National Coverage Determination for Implantable Automatic Defibrillators is silent on appropriate site of service for patients undergoing ICD and CRT-Ds procedures.

This meeting with CMS is the first step in a multi-dimensional approach the Society will use to address problems inherently linked to the use of RACs. The Society will convene a Task Force to develop appropriateness criteria for hospital admission vs. outpatient observation, as well as initiate a series of Capital Hill meetings to support it’s objectives.