Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R2)

CMS proposes that the evidence is not adequate to conclude that the use of magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) or implantable cardioverter defibrillators (ICDs), and thus propose that it is not reasonable and necessary under ß1862(a)(1)(A) of the Social Security Act (the Act). Therefore, subject to one exception, they are proposing to retain the current general contraindications at 220.2.C.1 in the NCD Manual. CMS believes that the evidence is promising although not yet convincing that MRI will improve patient health outcomes if certain safeguards are in place to ensure that the exposure of the device to an MRI environment adversely affects neither the interpretation of the MRI result nor the proper functioning of the implanted device itself. They believe that specific precautions could maximize benefits of MRI exposure for beneficiaries enrolled in clinical trials designed to assess the utility and safety of MRI exposure. Therefore, CMS proposes that MRI will be covered by Medicare when studied in a clinical study under section 1862(a)(1)(E) (consistent with section 1142 of the Act) if the study meets specific criteria.