Anthem Blue Cross Connecticut TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products Form

This document addresses uses of stem cell therapy for the prevention and treatment of health conditions, including but not limited to, peripheral vascular disease, and orthopedic, autoimmune, inflammatory, and degenerative conditions. Stem cell therapy involves the use of stem cells (usually in the form of an injection or infusion) to repair damaged cells and body tissues. The document also addresses the use of autologous cell therapy using, but not limited to the use of, skeletal myoblasts, endothelial progenitor cells (EPCs), and bone marrow mononuclear cells (BMMC) for the treatment of a wide variety of conditions, including damaged myocardium. In addition, autologous blood derived wound products, platelet rich plasma (PRP), and autologous protein solution for the treatment of skin wounds, various musculoskeletal injuries, and during various surgical procedures are addressed.

This document does not address: stem cell therapy used for disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment (including transplantation of autologous or allogeneic stem cells), or autologous hematopoietic stem cell-based gene therapy. FDA-approved stem cell products are listed on the FDA website here: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

Note: Please be aware that use of recombinant human platelet-derived growth factor (becaplermin [Regranex^®]) or bioengineered autologous skin-derived products (for example, SkinTE^™, MyOwn Skin^™) are not addressed in this document.

Note: This document does not address therapeutic uses of stem cells for hematopoietic indications (FDA-approved products derived from stem cells that are approved for limited use in individuals with disorders involving the hematopoietic system).

First identified in the hematopoietic system, stem cells are likely to be present in many other tissues. Stem cells can be derived from human embryos or somatic tissues in the adult or they can be created by inducing greater potency in an already differentiated somatic cell. Examples of adult stem cells (also called somatic stem cells or tissue-specific stem cells) not used for hematopoietic indications include, but are not limited to, mesenchymal (also called stromal stem cells), neural, epithelial, epidermal, and follicular. Extraction sources of adult stem cells include, but are not limited to, blood, bone marrow, adipose tissue, umbilical cords, placentas, and amniotic fluid. Other types of stem cells transplanted include peripheral bone marrow mononuclear cells [PBMNCs], and bone marrow mononuclear cells [BMMNCs].

Notes:

• This document does not address mesenchymal stem cells as an adjunct to spinal fusion or surgical procedures involving bone.
• For additional information on related topics, please see the following:
  • MED.00110 Silver-based Products for Wound and Soft Tissue Applications
  • MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures
  • SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting

Position Statement

Investigational and Not Medically Necessary:

1. Stem cell therapy, including but not limited to mesenchymal stem cell therapy is considered investigational and not medically necessary for the prevention and treatment of all conditions, including but not limited to:
   1. Peripheral vascular disease; or
   2. Orthopedic conditions; or
   3. Autoimmune conditions; or
   4. Inflammatory conditions; or
   5. Degenerative conditions.
2. Autologous cell therapy, including but not limited to, skeletal myoblasts, mesenchymal stem cells, endothelial progenitor cells (EPCs) or bone marrow mononuclear cells (BMMC), is considered investigational and not medically necessary for all indications, including but not limited to treatment of damaged myocardium.
3. Autologous blood-derived wound products (for example, Aurix [formerly Autologel], Vitagel) are considered investigational and not medically necessary for all applications.
4. Use of platelet rich plasma (PRP), including autologous conditioned plasma (ACP), is considered investigational and not medically necessary for all indications, including the treatment of any of the following:
   1. Cutaneous wounds; or
   2. Soft tissue injuries (including epicondylitis and sinus surgery); or
   3. Bone injuries (including surgically created wounds and non-unions).
5. Use of bone marrow aspirate concentrate (BMAC) is considered investigational and not medically necessary for all indications, including for the treatment of critical limb ischemia.
6. Use of autologous protein solution (for example, nSTRIDE^®), also known as autologous white blood cell concentrate, is considered investigational and not medically necessary for all indications.

Note: This document does not address stem cell therapy used for disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment, or hematopoietic stem cell transplantation.