CMS’s recent national coverage decision ends the Coverage with Evidence Development (CED) requirement for physicians seeking to perform MRIs on patients with a cardiovascular implanted electronic device (CIED).

In 2011, CMS established a CED for patients with CIEDs, which include implanted pacemakers, implantable cardioverter defibrillators, and related combination devices in cardiac resynchronization therapy pacemakers and defibrillators. Under the terms of the 2011 CED, CMS would only cover MRIs for those patients if the scan was part of one of nine clinical studies examining the use of MRIs on patients with CIEDs or the patient’s device was FDA-approved for MRI machines.  At that time, CMS was not yet convinced that MRIs would improve outcomes for patients with CIEDs and sought further study.

One of those nine approved clinical studies of MRIs under the CED has been completed, and CMS’s April 10, 2018 national coverage decision indicates its acceptance that it is clinically appropriate to use MRIs to inform diagnosis and management of patients with CIEDs .  CMS concluded that MRI quality, accuracy, sensitivity, and specificity were unaffected by CIEDs and a “published evidence base demonstrated that MRI scans in patients with CIED, when conducted under a checklist can be conducted without major adverse events.”

As a result, CMS will cover MRI scans for patients with CIEDs even if that patient’s device does not have an FDA label specific for use in an MRI environment if the facility develops a checklist with the following criteria:

• Patient assessment is performed to identify the presence of an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator;
• Prior to the MRI scan, benefits and harms of the MRI scan are communicated with the patient or the patient’s delegated decision-maker;
• Prior to the MRI scan, the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is interrogated, meaning its characteristics are recorded and its pre-scan parameters restored post-scan, and programmed appropriately during the scan based on device and patient characteristics;
• A qualified physician, nurse practitioner or physician assistant with expertise with an implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator must directly supervise the MRI, meaning the physician, nurse practitioners, or physician assistant must be immediately available to furnish assistance and direction throughout the performance of the procedure;
• Patients are observed throughout the MRI scan via visual and voice contact and monitored with equipment to assess vital signs and cardiac rhythm;
• An advanced cardiac life support provider must be present for the duration of the scan; and
• A patient discharge plan that includes patient evaluation and ensures that the implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy pacemaker, or cardiac resynchronization therapy defibrillator is reinterrogated immediately after the MRI scan to detect and correct any abnormalities that might have developed during the MRI.

While CMS ended the CED requirement, it still encouraged providers to continue a voluntary registry to identify and develop approaches to additionally reduce risk of minor complications related to MRI scanning on patients with CIEDs.