CMS Expands Medicare Coverage of MRI for Patients with FDA-Approved Pacemakers

The Centers for Medicare & Medicaid Services (CMS) recently expanded Medicare coverage of MRI for beneficiaries with implanted pacemakers when used according to FDA-approved labeling in an MRI environment. A final National Coverage Determination (NCD) provides access to the MRI environment for patients with FDA-approved pacemakers.

On February 8, the FDA approved the RevoMRI SureScan Pacing System, which is designed for use in the MRI environment for certain MRI exams. Currently, there are no other pacemakers or implantable cardioverter defibrillators that are FDA-approved for use in the MRI environment.

“This swift action by CMS provides patients who need a pacemaker with greater access to MRI exams,” said Donald M. Berwick, MD, CMS administrator. “The expedited review of this decision demonstrates our commitment and support of new technology that will help improve the health of our beneficiaries.”

The final decision memorandum is available on the CMS Website.