Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R3)

CMS has determined that the evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment. Therefore we determine that this use of MRI is reasonable and necessary under ß1862(a)(1)(A) of the Social Security Act (the Act). CMS will change the language in section 220.2.C.1 of the NCD Manual to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs when the PMs are used according to the FDA-approved labeling for use in an MRI environment. Other contraindications that may be present in any given beneficiary would continue to apply in patients with PMs.