Stem Cell Therapy for Peripheral Arterial Disease

This policy addresses stem cell therapy—primarily autologous hematopoietic or bone marrow–derived cell implantation/administration—for peripheral arterial disease (PAD), including critical limb ischemia (CLI), intended for severe, limb‑threatening ischemia or “no‑option” patients who have failed or are not candidates for revascularization to promote angiogenesis, ulcer healing, improve ABI/function, and reduce amputations. Major limitations are that the therapy is considered experimental/investigational and not covered (including concentrated bone marrow, in‑vitro–expanded, peripheral blood–stimulated, and allogeneic sources); evidence is limited and heterogeneous, and coverage is subject to member benefit, state rules, and requirements such as large‑volume bone marrow harvest.

"Treatment of peripheral arterial disease (PAD), including critical limb ischemia characterized by ischemic rest pain, ulcers, or significant risk for limb loss"