The Centers for Medicare and Medicaid Services (CMS) recently finalized a plan to cover magnetic resonance imaging (MRI) scans for patients with pacemakers. Historically, the CMS has not covered these scans out of a concern that the strong magnets could damage or disrupt the devices. However, recent evidence from large studies prove that MRI scans can be safe for patients with implanted devices.
The finalized plan provides a checklist for healthcare facilities to follow before scanning a patient with a cardiac device.
The list implements a series of steps to prevent disruptions in implanted devices through an abundance of caution. The required criteria include the following:
- A patient assessment must be performed to identify the implanted pacemaker.
- The facility must communicate the potential benefits and harms of the MRI scan before the scan takes place.
- The device must be programmed to the appropriate mode for the duration of the scan.
- A qualified healthcare professional with expertise with implanted devices must supervise during the scan.
- Patients must be observed visually and by voice contact throughout the scan.
- A cardiac life support provider must be present during the scan.
- The device must be re-interrogated after the scan to ensure correct programming.
To qualify for coverage, the MRI field strength must be less than or equal to 1.5 Tesla. While some doctors feel this is too stringent, the CMS contends that there is not enough evidence to prove stronger fields are safe. The implanted devices must also not have any fractured, epicardial, or abandoned leads.
The CMS has eased two rules that were once part of the proposal. The agency has removed language that prohibits pacemaker-dependent patients from getting scans as well as patients whose pacemakers have been implanted within six weeks of the scan.
The decision comes in the wake of mounting evidence.
A large, nonrandomized study of 1509 patients with cardiac devices showed that none of the patients suffered long-term clinically significant adverse effects after an MRI scan. The results were published in late 2017 in the New England Journal of Medicine. Several years earlier, a similarly large study from MagnaSafe conducted scans on 1500 patients with cardiac devices with no major adverse effects.
The lead author of the MagnaSafe study, Dr. Robert J. Russo told Healio, “The MagnaSafe Registry demonstrates that clinically indicated non-thoracic MRI at 1.5T can be performed with non-conditional standard devices at no significant clinical risk when patients are appropriately screened and the devices are appropriately programmed.”
While it took several years for the CMS to accept these findings, MRI scan coverage for patients with pacemakers is now just around the corner. The official memo from CMS does not give a date when the changes will take effect, but the plan appears to be in its final form.
These two large studies and the CMS’s embrace of their findings prove that, when proper precautions are taken, patients with implanted devices can safely undergo MRI scans. Because non-invasive MRI scans can help with everything from cancer detection to diagnosing orthopedic injuries, that’s great news for patients with implanted devices.