Interventional technology firm Medtronic of Minneapolis has asked the U.S. Centers for Medicare and Medicaid Services (CMS) to change some of the language in the agency's national coverage decision (NCD) review of the appropriateness of flow analysis and mapping in cardiac MR studies.
Medtronic is requesting that the reference to cardiac pacemakers be revised to include coverage for devices that have been designed, tested, and FDA labeled for use in the MRI environment.
Cardiac pacemakers are one of two devices contraindicated for MRI scanning in the original policy, which was developed in 1994. Since that time, Medtronic noted that there have been national guidelines created to support the careful use of MRI with pacemaker patients.
Medtronic is requesting that the language read: "The MRI is not covered when the following patient-specific contraindications are present. It is not covered for patients with devices that have not been approved or cleared by the FDA/or use in the MRI environment ... at this time."
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