Section 220.2 of the NCD Manual, as recently updated, establishes coverage of MRI for a number of uses. Coverage is limited to MRI units that have received FDA premarket approval. However, payment for an MRI examination is not covered by Medicare for patients with cardiac pacemakers (Section 220.2, C.1):
"The MRI is not covered when the following patient-specific contraindications are present. It is not covered for patients with cardiac pacemakers or with metallic clips on vascular aneurysms. MRI during a viable pregnancy is also contraindicated at this time. The danger inherent in bringing ferromagnetic materials within range of MRI units generally constrains the use of MRI on acutely ill patients requiring life support systems and monitoring devices that employ ferromagnetic materials. â€¦ "
CMS has received a request to reconsider the NCD for MRI. The requestor has asked that the contraindication to coverage for MRI be modified for patients with cardiac devices who undergo MRI if: (1) a clinically-indicated MRI is performed as part of a prospective clinical trial designed to determine the risk of the procedure, and (2) the study is conducted after an Investigational Device Exemption (IDE) has been approved by the Food and Drug Administration (FDA) for the proposed research.