In the decision memo, CMS noted that "the weight of the published literature in this field provides convincing evidence that, with appropriate precautions, MRI can be performed with minimal risk in Medicare beneficiaries with CIEDs [Cardiovascular Implantable Electronic Devices]." This follows a study published last December in the New England Journal of Medicine in which the authors concluded that MRIs performed on patients with non-MRI-conditional devices resulted in no long-term clinically significant adverse events.
CMS did set up specific conditions that imaging programs must meet when performing these scans:
- MRI field strength is 1.5 Tesla using Normal Operating Mode;
- The implanted device has no fractured, epicardial, or abandoned leads;
- The facility implements a checklist including:
- A patient assessment to identify the presence of the implanted device
- Communication about the benefits and harms of the MRI to the patient
- Interrogation and programming of the implanted device prior to the scan
- Supervision of the exam by a qualified physician, nurse practitioner, or physician assistant
- Observation of the patient during the scan
- Presence of an advanced cardiac life support provider during the scan
- Discharge plan that includes before discharge that the implanted device is reinterrogated after the scan to "detect and correct any abnormalities that might have developed during the MRI"
According to the American College of Cardiology, there are approximately 200,000 new pacemakers implanted each year, so this change could have a significant impact on MRI volumes. Here are two things your imaging program can do to be ready to meet the needs of these new imaging patients.
Strategy #1: Shore up your MRI screening process
As noted above, one of the conditions that CMS laid out was that the imaging facility must conduct a patient assessment to identify the presence of an implanted medical device. Most imaging programs rely on an MRI screening form to accomplish this task. While these forms are a useful tool, there are opportunities to improve on these processes.
Here's an example of how one organization, Southern Illinois Healthcare, took the standard MRI screening form and developed a multi-level screening process. Their strategy ensures that patients are asked about implantable devices by multiple people in multiple ways, to ensure imaging staff correctly identify all devices.
Strategy #2: Appoint an "owner" of implanted devices
Whether it's a pacemaker, joint implant, insulin pump, or other implanted device, knowing that a patient has a device is only half the battle. Imaging programs must also understand if that device can enter the MRI room and under what conditions. This process requires research, discussions with manufacturers, and a deep understanding of MRI protocols. While many organizations ask all their MRI technologists to perform these tasks, some progressive organizations are moving to centralize this process with one or two people. These conditional device experts, who often receive certification as MRI Safety Officers through the American Board of Magnetic Resonance Safety, take on crucial tasks including:
- Reviewing the schedule and identifying those patients with implantable devices
- Fielding all calls from ordering providers around the safety of implanted devices
- Leading research on each identified device, including necessary discussions with manufacturers
- Forming a recommendation to the radiologist about whether the MRI can take place