The U.S. Centers for Medicare and Medicaid Services (CMS) has issued a final rule indicating that there is not enough data to change current policy against reimbursing for the use of MRI for patients with implanted permanent pacemakers (PMs) or implantable cardioverter defibrillators (ICDs).
In its decision, the agency stated that while the evidence is "promising," CMS is not yet convinced that MRI will "improve patient health outcomes." However, the agency said it would cover the use of MRI in this application in the context of clinical studies that meet certain criteria.
Such studies must address one or more questions, such as whether the results of MRI in PM/ICD beneficiaries with implanted cardiac devices affect clinical management strategy, alter planning of treatment interventions, or prevent unneeded diagnostic studies, interventions, or preventable exposures.
In addition, clinical study results must address the efficacy of patient outcomes related to survival, quality of life, and adverse events during and after MR scanning.
