Unless there is a specific national coverage determination for that device or service, determination as to whether a device or service that fits into the framework is reasonable and necessary is according to contractor discretion. Medical Officer, Division of Items and DevicesĪ marketed ambulatory cardiac monitoring device or service is eligible for coverage if it can be categorized according to the framework. Health Insurance Specialist, Division of Items and Devices To: File: Electrocardiographic Services (CAG-00158N) CMS, through the NCD process, may create new ambulatory electrocardiographic monitoring device categories if published, peer-reviewed clinical studies demonstrate evidence of improved clinical utility, or equal utility with additional advantage to the patient, as indicated by improved patient management and/or improved health outcomes in the Medicare population (such as superior ability to detect serious or life-threatening arrhythmias) as compared to devices or services in the currently described categories. If a marketed ambulatory cardiac monitoring device or service cannot be categorized according to the framework, then that device is non-covered nationally. Further, this decision memorandum does not prescribe a sequence of diagnostic tests for evaluating potential cardiac arrhythmias.Ī marketed ambulatory cardiac monitoring device or service is eligible for coverage if it can be categorized according to the framework. This decision memorandum does not eliminate coverage of any particular device that is currently covered by existing policy nor does it recommend use of a particular device for particular indications. This decision memorandum modifies existing coverage policy by organizing technologies for ambulatory electrocardiography into a framework to aid our contractors in making reasonable and necessary determinations for specific technologies.
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