Health First Individual & Family Form

Medical Policy Subject: Cardiac Contractility Modulation (CCM) Therapy - Optimizer® Device Applies To: Individual and Family Plans Policy Number: MP-0232 Effective Date: January 2024 Revised: New Document Page Length: 4 Medical Policy Statement: Cardiac Contractility Modulation (CCM) Cardiac contractility modulation will not be considered medically reasonable and necessary. A review of the current literature shows that the evidence is insufficient to determine that this service is standard medical treatment. There remains an absence of randomized, blinded clinical studies examining benefit and long-term outcomes establishing the value of this service in clinical management. Definitions: Cardiac Contractility Modulation (CCM)- CCM is a novel therapy in which the patient’s cardiac muscle is electrically stimulated during the absolute refractory period. CHF- Congestive Heart Failure Description: The Optimizer® smart system is a first-of-its-kind, implantable cardiac contractility modulation (CCM) therapy delivery device developed by Impulse Dynamics. It is the first-approved CCM device for the treatment of moderate to severe chronic heart failure in patients, who are at risk despite medical treatment. The device received a breakthrough device designation from the US Food and Drug Administration (FDA) in 2015. The FDA provided clearance for its clinical use in March 2019. The first patient was implanted with the device at the Ohio State University Wexner Medical Centre in May 2019. The Optimizer device is implanted in the pectoral region on the right side of the patient at a maximum depth of 4cm and connected to two conventional pacemaker leads positioned on the ventricular septum at a distance of around 2cm. The leads are attached to the right ventricle through veins, with one tracking ventricular activity and the other tracking atrial activity. The leads deliver electric CCM signals to the heart’s right ventricle at regular intervals throughout the day. Medical Policy