WASHINGTON -- The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is strong enough to reimburse for MRI exams in Medicare patients who have permanent pacemakers.
"We propose to change the language ... of the NCD Manual to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs [permanent pacemakers] when the PMs are used according to the FDA-approved labeling for use in an MRI environment," the agency's proposed decision memorandum states.
The FDA approved the first MRI-conditional pacemaker (Medtronic Revo MRI SureScan Pacing System) on Feb. 8, but CMS specifically noted that the change in payment policy "does not include any coverage determination about the Medtronic Revo MRI SureScan Pacing System itself or any other pacemaker."
The proposed coverage is not limited to any specific disease or condition.
The new decision broadens one announced on Feb. 24, when CMS said it would cover MRI exams only for patients with pacemakers if they were enrolled in approved clinical studies of MRI.
The next day, CMS received a request letter from Medtronic referencing the randomized controlled trial of 464 pacemaker patients demonstrating the safety of the device in the MR environment and provided CMS with a reference to the journal in which the study was published.
"The requester asked that CMS remove completely the contraindication in the MRI policy for patients with pacemaker devices that have been approved by the FDA for use in the MR environment," according to the CMS decision memorandum.
Following a 30-day public comment period regarding coverage of MRI scans in patients with pacemakers, CMS concluded that "this use of MRI is reasonable and necessary."
Primary Source
Centers for Medicare & Medicaid Services
Jacques L, et al "Proposed Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R3)" CMS 2011.