Electrocardiographic recordings are graphic representations of electrical activity generated by structures within the heart. Devices that produce these recordings are used to diagnose a wide range of heart diseases and other conditions that may cause abnormal cardiac electrical activity. They may be used in the inpatient or outpatient setting and while the patient is sedentary or ambulatory.
Ambulatory electrocardiography refers to services rendered over a specified period of time, generally while a patient is engaged in daily activities, including sleep, and is intended to provide physicians with documented episodes of intermittent dysrhythmia that may be related to patient symptoms. Such symptoms include syncope, dizziness, chest pain, palpitations or shortness of breath. Ambulatory electrocardiography is also used to monitor anti-arrhythmic drug treatment.
The Centers for Medicare & Medicaid Services (CMS) has a long-standing national coverage policy for electrocardiographic services in Section 50-15 of the Coverage Issues Manual (CIM). However, since we first issued this policy over 15 years ago, these technologies have evolved. To keep our national coverage policy current, CMS initiated an internal request to update and organize CIM 50-15 to account for the types of technologies now available. It is not our intent in this review to remove existing coverage. Instead we plan to organize existing technologies for ambulatory electrocardiography into a framework to aid our contractors in making reasonable and necessary determinations for specific technologies.
CMS seeks public comment on its draft framework (see below). To add a new category of device to the framework, CMS would be particularly interested in reviewing published, peer-reviewed clinical studies demonstrating the advantages of one type of technology over another in test performance (e.g., does the device provide more accurate, reproducible data as compared to other devices) and effect on patient management.
Our review does not address the use of electrocardiographic services for cardiac pacemaker monitoring, implantable defibrillators or for pediatric populations.
