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The Centers for Medicare & Medicaid Services (CMS) finalized a proposed plan to cover MRI scans for patients with implanted pacemakers, implantable cardioverter defibrillators (ICDs), and either type of device featuring cardiac resynchronization therapy (CRT).
The dropped data collection for MRI among patients with implanted cardiac devices and expanded coverage beyond MRI-conditional devices, as expected from the proposed coverage memo released in January.
CMS will reimburse MRI used in patients with MRI-conditional devices used according to the FDA labeling as well as those with devices without FDA labeling specific to use in an MRI environment, but only when the MRI field strength is no more than 1.5 Tesla using Normal Operating Mode and the cardiac device has no fractured, epicardial, or abandoned leads.
However, there were a few changes from the proposed to the final version of the coverage determination that will be meaningful for clinical implementation. Notably, the that patients not be pacemaker dependent was dropped, as was the criterion of waiting at least 6 weeks after device implantation or any lead revision or surgical modification.
In another change, CMS added to the requirements for medical staff expertise on hand during the scan, compared with what had been proposed in January. The final list of the checklist facilities must implement when scanning a cardiac device patient without an MRI-conditional device was:
- Assessment to identify the presence of an implanted cardiac device
- Before the scan, communicate benefits and harms of the MRI scan with the patient or the patient's delegated decision-maker, interrogate and program the device appropriately for its and the patient's characteristics
- During the scan, a qualified physician, nurse practitioner, or physician assistant with expertise with implanted cardiac devices must directly supervise and visual and voice contact be maintained with the patient throughout the scan along with vital sign and cardiac rhythm monitoring
- An advanced cardiac life support provider must be present for the duration of the scan
- Immediately after the scan, the implanted cardiac device should be reinterrogated to detect and correct any abnormalities that might have developed
CMS noted that public comments received by the agency after the proposal was released had requested removing the specification of the MRI field strength. But the final determination noted that most of the reviewed studies used 1.5-T, whereas "there is a paucity of evidence to support that the benefits of using 3.0-T MRI in patients with CIEDs [cardiovascular implantable electronic devices] that do not have FDA labeling specific to use in an MRI environment outweigh the harms."