CMS Proposes Widening MRI Coverage for Cardiac Devices

Patrice Wendling

January 16, 2018

The Centers for Medicare & Medicaid Services (CMS) is considering expanding coverage for magnetic resonance imaging (MRI) beyond MRI-conditional cardiac devices and eliminating the Coverage with Evidence Development (CED) requirement for additional clinical data.

The proposal, posted in a January 11 memo,[1] updates the agency's 2011 national coverage determination policy and reflects the growing body of evidence supporting the safety of MRI in patients with cardiac devices that do not carry MRI-conditional labeling.

Specifically, the update would eliminate the contraindication for Medicare coverage of MRI in patients with an implanted pacemaker or implantable cardioverter defibrillator (ICD) and expand coverage to include cardiac resynchronization therapy (CRT) pacemakers or CRT defibrillators.

For such devices without US Food and Drug Administration labeling for use in an MRI setting, coverage is contingent on specific conditions, such as a field strength of 1.5 Tesla or less; at least a 6-week delay since device implantation, lead revision, or surgical modification; and that the patient neither is pacemaker dependent nor has a system with fractured, epicardial, or abandoned leads.

There is also a checklist for MRI facilities that includes such steps as programming the device to the appropriate MRI scanning mode, direct MRI supervision by qualified staff, and establishing a detailed discharge plan.

CMS is seeking public comments on the proposed changes and will respond to these comments in a final decision memorandum.

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