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MRI for Pacemaker Patients Is 1 Step Closer to Coverage
Published on Fri May 13, 2011
FDA-approved labeling should be your guide.CMS posted a proposed decision memo (PDM) in favor of covering MRI scans for patients with MRI-safe pacemakers.The key is following the pacemaker's FDA-approved labeling for MRI. The PDM states that CMS "proposes that the evidence is adequate to conclude that magnetic resonance imaging (MRI) improves health outcomes for Medicare beneficiaries with implanted permanent pacemakers (PMs) when the PMs are used according to the FDA-approved labeling for use in an MRI environment. Therefore we propose that this use of MRI is reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act)."What's next: If the PDM is finalized, expect a change to section 220.2.C.1 of the National Coverage Determination (NCD) manual to match the new decision.Stay focused: The PDM states that it relates to MRI coverage -- coverage of the Medtronic RevoMRI SureScan (FDA-approved as MRI safe) doesn't fall under the scope of the PDM.Resources: [...]