National Coverage Analysis (NCA) Tracking Sheet for Magnetic Resonance Imaging (MRI) (CAG-00399R3)

Magnetic resonance imaging (MRI) is a noninvasive method of graphically representing the distribution of water and other hydrogen-rich molecules in the human body. MRI is a useful diagnostic imaging modality that is capable of demonstrating a wide variety of soft-tissue lesions with contrast resolution equal or superior to computerized tomography (CT) scanning in various parts of the body. Section 220.2 of the National Coverage Determination (NCD) Manual, as recently updated, establishes coverage of MRI for a number of uses. Aside from an exception for MRI furnished in approved clinical studies of implanted pacemakers and implantable cardioverter defibrillators (ICDs) under the Coverage with Evidence Development (CED) paradigm, MRI is generally noncovered when certain patient-specific contraindications are present, including, among others, patients who have implanted cardiac pacemakers. FDA recently approved the first pacemaker (Medtronic Revo MRI Sure Scan Pacing System) for use during certain MRI exams on February 8, 2011. The FDA approval letter includes several post approval requirements for ongoing study and data submission. This 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. This reconsideration is limited to MRI and does not include any coverage determination about the Medtronic Revo MRI Sure Scan Pacing System itself or any other pacemaker. See Medicare’s NCD on Cardiac Pacemakers at 20.8 of the NCD Manual. We are opening this new MRI reconsideration to review the evidence and obtain public comment. We may determine the conditions under which MRI for patients with implanted devices, when furnished fully within FDA approved labeling for use in an MR environment, including post approval study requirements, may be reasonable and necessary under sections 1862(a)(1)(A) and/or 1862(a)(1)(E) of the Social Security Act. We are particularly interested in receiving comment on coverage in the context of FDA post approval requirements.