Following the FDA’s February approval of a Medtronic MRI-safe pacemaker, the Centers for Medicare & Medicaid Services (CMS) has reopened its consideration of coverage for pacemakers one a week after announcing it would only reimburse for clinical trials.
On Feb. 24, CMS announced it would continue to refuse coverage for MRI scans of patients with implanted pacemakers and implantable cardioverter defibrillators (ICDs), except in clinical trials examining the devices’ safety under the imaging technique. Last week, however, CMS said it would reopen the investigation to consider whether Medtronic’s Revo MRI SureScan, a pacemaker approved by the FDA for use under MRI, and other 510(k) FDA approved MRI-safe devices merit Medicare and Medicaid coverage in patients ordered for MRIs.
In a statement on its website, CMS said the FDA “approval came after the close of public comment period on our recent reconsideration of the MRI NCD (CAG-00399R2, published February 24, 2011) and too late for CMS to adequately review the evidence and issue a final decision before the statutory due date.”
CMS stated that it will reopen its consideration and call for public comment, expressing its specific interest in hearing comments regarding coverage in the context of FDA post approval requirements.