CMS Issues Decision for Implantable Cardioverter Defibrillators

February 2018 ~

CMS’ decision memo, released on February 15th, for implantable cardioverter defibrillators explains that the agency has determined that the use of implantable cardioverter defibrillators (ICDs or defibrillators) is reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member under the Social Security Act.

The agency has made the following changes to the Analysis section of the NCD decision memo:

Patient Criteria

  • Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF);
  • Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months;
  • Require a patient shared decision making (SDM) interaction prior to ICD implantation for certain patients.

Additional Patient Criteria

  • Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT).

Exceptions to Waiting Periods

  • Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
  • Add an exception for patients with an existing ICD and qualifying replacement.

Registry Requirement

  • End the data collection requirement.

For more information, see the full ICD decision memo here.

 

Source(s): CMS;

 

 

 

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