The Centers for Medicare and Medicaid Services (CMS) announced it is considering dropping data collection as part of a national coverage determination for MRI among patients with implanted cardiac devices — and expanding coverage beyond MRI-conditional devices.
The agency started paying for MRI in patients with implanted permanent pacemakers with “MRI-friendly” FDA-approved labeling in 2011. In October 2017, it announced a proposal to expand coverage of MRI for implantable cardioverter defibrillators (ICDs) and remove the registry requirement.
The new proposed update would eliminate the contraindication for MRI in any patient with an implanted pacemaker or ICD and further expand the coverage to include cardiac resynchronization therapy (CRT) devices and CRT-defibrillators — even those without specific FDA labeling for compatibility with MRI under certain criteria.
Researchers have increasingly indicated that MRI is safe with non-MRI-conditional implanted cardiac devices when safety protocols are followed for 1.5-Tesla scans.
The proposed national coverage determination would specify that devices without MRI-conditional labeling should be used with a field strength of no more than 1.5 Tesla and be in patients without pacemaker dependency or fractured, epicardial, or abandoned leads along with certain safety steps like putting the device into an appropriate mode before scanning and reinterrogating it before discharge.