The Centers for Medicare & Medicaid Services (CMS) has issued a proposal to reimburse providers for MRI scans of Medicare beneficiaries with implanted permanent pacemakers when used according to the FDA-approved labeling for use in an MRI environment.
The decision follows a Feb. 24 final decision memorandum which determined that CMS would cover MRI for beneficiaries with implanted pacemakers or implantable cardiac defibrillators in approved clinical studies of MRI.
Following that decision, CMS received a letter from Medtronic, noting that the FDA had approved Medtronic’s RevoMRI SureScan Pacing System on Feb. 8. The letter also referenced a randomized controlled trial of 464 pacemaker patients published in the January issue of Heart Rhythm, which indicated the safety of the device in the MR environment.
CMS proposed the revision after considering the evidence. However, in its decision, CMS emphasized, “The scope of this reconsideration is limited to Medicare coverage of MRI and does not include any coverage determination about the Medtronic RevoMRI SureScan Pacing System itself or any other pacemaker.”