Inside the U.S. Food and Drug Administration (FDA)

This policy addresses coverage of FDA‑regulated products and related therapies — including human drugs, biologics, blood products, medical devices, radiation‑emitting products, foods/dietary supplements, and cosmetics — and specifies that drug therapy is covered only when dose/frequency/duration align with authoritative sources and the treatment is proven effective per current peer‑reviewed literature. Coverage applies to members receiving these products (including potential off‑label use only if specifically addressed by a separate HCSC off‑label policy), with major limitations requiring FDA marketing approval and clear evidence of clinical efficacy, adherence to the member’s benefit plan and state rules, and exclusion of non‑FDA‑approved, experimental, investigational, or unproven uses.

"Therapy is medically necessary and covered only when proven effective for the relevant diagnosis per current peer‑reviewed literature and accepted standards of practice."