CMS published a memo April 10 that finalized a proposal to cover MRI scans for Medicare beneficiaries with implantable cardiac devices (ICDs).
“We determined that the evidence is sufficient to conclude that MRI for Medicare beneficiaries with an [ICD] is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member … under certain circumstances,” according to the CMS memo.
CMS originally proposed the change on Jan. 11, citing evidence that supported MRIs in patients with cardiac devices. That move came in the wake of a New England Journal of Medicine study that found many safety concerns were outdated, if not entirely incorrect. Public comment on the proposal was open until Feb. 10.
MRIs for patients with ICDs that do no have FDA labeling allowing for use in an MRI environment are only covered if the following conditions are met:
- The MRI field strength is 1.5 Tesla when using “Normal Operating Mode.
- The device “has no fractured, epicardial or abandoned leads.”
- The facility has implemented a seven-item checklist that includes communicating the benefits and harms of the scan to the patient, keeping an advanced cardiac life support provider present during the scan, and five other required actions.
CMS also eliminated some elements of its January proposal, including mandating patients wait at least six weeks after device implementation to undergo MRI.