What options do physicians and hospitals have when reimbursement rules are out of sync with current clinical guidelines and appropriate use criteria? Cardiologists used implantable cardioverter-defibrillators (ICDs) to illustrate this disconnect in the Jan. 7-14 issue of the Journal of the American College of Cardiology.

Guideline writers published the most recent recommendations for device-based therapies for arrhythmias in 2012 to help physicians manage patients who may need devices such as pacemakers or ICDs. Appropriate use criteria released in 2013 offered more assistance by addressing a broader set of scenarios in the clinical setting.

Medicare’s National Coverage Determination (NCD) for primary prevention ICD implantation, defines what therapies are reimbursable, dates back to 2005, pointed out lead author Richard I. Fogel, MD, of St. Vincent Medical Group in Indianapolis, and colleagues. The NCD was primarily based on data from randomized controlled clinical trials that had restricted inclusion criteria, which puts the NCD out of step with the more contemporary appropriate use criteria.     

“[P]atient-centered care may warrant implantation of a device appropriate for the individual patient’s situation that does not fit precisely into a covered NCD,” they wrote in the viewpoint. “Importantly, this may place practitioners and hospitals at risk for denial of payment or investigation for possible abuse or fraud even when the decision was clinically justified.”

An expanded investigation by the Department of Justice (DOJ) intensified worries, and while the DOJ has developed a settlement resolution model that acknowledges uses outside the NCD as valid, it is applied retrospectively. “Just because an indication falls within the DOJ bucket list does not indemnify the physician from future liability,” Fogel and colleagues warned. “The resolution model does not replace or update the NCD and should not be utilized to determine whether an ICD is currently payable by Medicare.”

Cardiologists and electrophysiologists can take steps to rectify the situation. The authors encouraged their peers to contact their professional societies to advocate on their behalf, but to be sure to understand the guidelines, appropriate use criteria and to “practice within the scope of the ICD NCD whenever possible.” Other options when an ICD is medically appropriate but not covered under the NCD include:

• Use of an external defibrillator vest;
• Waiving the charge for the device;
• Proactively informing Medicare’s fiscal intermediary to ensure there is no misinterpretation that would lead to charges of fraud or deceit; and
• Having the patient sign an Advanced Beneficiary Notice ascertaining that he or she knows he or she may be charged for the device.

They emphasized that all options should be meticulously documented and recommended teaching coders about clinical nuances.

“In an ideal world, the NCD should be constructed in a flexible format enabling ease for adaptable coverage criteria to be congruent with the evidence-based science and appropriate clinical use,” they wrote. In the meantime, they suggested the Heart Rhythm Society, the American College of Cardiology and the American Heart Association collaborate with the Centers for Medicare & Medicaid Services in an effort to achieve congruence.