Cardiac Contractility Modulation (CCM) Device

This policy addresses cardiac contractility modulation (CCM) device therapy (e.g., the Optimizer Smart System) for patients with NYHA Class III heart failure and left ventricular ejection fraction (LVEF) 25%–45% who remain symptomatic despite guideline‑directed medical therapy and are not candidates for cardiac resynchronization therapy (CRT). Although FDA‑labeling and guidelines note improvements in exercise capacity and quality of life, the policy treats CCM implantation as experimental/unproven and permits use only within clinical research (preferably randomized trials), excludes CRT candidates, and notes insufficient evidence for reductions in mortality or hospitalizations.

"Use of diagnostic tests (blood tests, electrocardiogram, chest x‑ray, stress test, echocardiogram) to aid in diagnosing heart failure."

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