Lipid Apheresis

This policy covers LDL (lipid) apheresis as a therapeutic procedure to acutely and chronically lower LDL‑C in familial hypercholesterolemia, primarily for homozygous FH and for select heterozygous FH patients who have failed diet and maximal tolerated drug therapy (e.g., LDL ≥300 mg/dL, or ≥200 mg/dL with documented coronary artery disease). Major limitations/requirements include adult‑only use, documented adherence and inadequate response to maximized pharmacotherapy before escalation to apheresis, frequent maintenance treatments (typically every 1–2 weeks) to maintain LDL targets, restriction to FDA‑approved/HDE methods, and that apheresis is investigational for other indications.

"LDL apheresis is medically necessary for individuals with homozygous familial hypercholesterolemia as an alternative to plasmapheresis."

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