CMS mulls expanded MRI coverage for CRM patients

The Centers for Medicare & Medicaid Services is thinking about extending coverage for magnetic resonance imaging scans to patients with cardiac rhythm management devices after reviewing studies showing that MRI scans are safe. If finalized the decision would allow Medicare patients with implanted MR-conditional devices such as pacemakers or defibrillators to have their MRI scans covered by the national healthcare program. “We propose that the evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,” the agency said Jan. 11. “Thus, we are proposing to modify our national coverage determination to eliminate the collection of additional information under the Coverage with Evidence Development paradigm.” CMS reviewed data, including results from a 1,500-patient study published last month in the New England Journal of Medicine, showing that even non-MR-conditional devices can be safely scanned. “We evaluated the safety of MRI, performed with the use of a pre-specified safety protocol, in 1509 patients who had a legacy pacemaker or a legacy implantable cardioverter–defibrillator s...
Source: Mass Device - Category: Medical Devices Authors: Tags: Wall Street Beat Cardiac Rhythm Management Centers for Medicare and Medicaid Services (CMS) Source Type: news