Anthem Blue Cross Connecticut MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures Form

This document addresses the following soft tissue augmentation procedures:

• Autologous adipose-derived regenerative cell therapy (for example, Lipogems);
• Autologous fat grafting* (autologous fat transfer); and
• Injectable soft tissue fillers.

Note: For procedures done as part of breast reconstruction, see SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures.

Note: This document does not address gender affirming surgery or procedures. Criteria for gender affirming surgery or procedures are found in applicable guidelines used by the plan.

Autologous adipose-derived regenerative cell therapy, (also referred to as autologous cellular implant derived from adipose tissue), involves the removal of a heterogenous mixture of cells derived from adipose tissue (including but not limited to adult stem cells, vascular endothelial cells, vascular smooth muscle cells, fibroblasts, T-regulatory cells, and macrophages) from one part of the body and injecting it into another part of the same body with the intent to modify, treat, reverse, or cure a disease or condition by contributing, inducing or promoting tissue healing. The use of stem cells that have been isolated in order to be used as a treatment or therapy for some condition, including adipose-derived stem cell therapy, is addressed in TRANS.00035 Other Stem Cell Therapy.

Autologous fat grafting is a soft tissue augmentation technique used to correct volume loss due to various causes including but not limited to trauma, congenital defects, surgical resection, radiation, or the natural process of aging.

Injectable soft tissue fillers are volume-producing agents that are injected or implanted into the dermal layers of the skin to correct reduce contour defects in the face, neck, and body through the replacement of tissue volume lost due to aging, trauma, or other events. Soft tissue fillers are used for multiple cosmetic and therapeutic indications. A variety of injectable filling agents are available, including temporary fillers that are composed of biodegradable ingredients, such as hyaluronic acid, collagen, calcium hydroxylapatite, and poly-L-lactic acid, and fillers that persist indefinitely in tissue (for example, those containing polymethylmethacrylate microspheres, silicone, or hydrogel polymers).

For related documents see:

• ANC.00007 Cosmetic and Reconstructive Services: Skin Related
• ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck
• ANC.00009 Cosmetic and Reconstructive Services of the Trunk, Groin, and Extremities
• MED.00110 Silver-based Products for Wound and Soft Tissue Applications
• SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures
• TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Medically Necessary: In this document, procedures are considered medically necessary if there is a significant functional impairment AND the procedure can be reasonably expected to improve the functional impairment.

Reconstructive: In this document, procedures are considered reconstructive when intended to address a significant variation from normal related to accidental injury, disease, trauma, treatment of a disease or a congenital defect.

Note: Not all benefit contracts/certificates include benefits for reconstructive services as defined by this document. Benefit language supersedes this document.

Cosmetic: In this document, procedures are considered cosmetic when intended to change a physical appearance that would be considered within normal human anatomic variation. Cosmetic services are often described as those that are primarily intended to preserve or improve appearance.

Position Statement

I.  Autologous Adipose-derived Regenerative Cell Therapy:

1. Autologous adipose-derived regenerative cell therapy (for example, Lipogems) is considered investigational and not medically necessary for all indications.

II.  Autologous Fat Grafting:

Autologous fat grafting is considered medically necessary when both of the following criteria have been met:

1. There is documented evidence of significant functional impairment: and
2. The procedure can be reasonably expected to improve the functional impairment.

Autologous fat grafting is considered reconstructive when there is a significant variation from normal related to any of the following:

1. Accidental injury; or
2. Disease; or
3. Trauma; or
4. Treatment of a disease or congenital defect (for example, for breast contouring following breast reconstruction procedures).

Autologous fat grafting is considered cosmetic and not medically necessary when the criteria above have not been met, including for:

1. Performed in the absence of a significant functional impairment; or,
2. Is not reconstructive; or
3. Is intended to change a physical appearance that would be considered within normal human anatomic variation.

III.  Injectable Soft Tissue Fillers (for example: poly-L-lactic acid [PLLA], synthetic calcium hydroxylapatite, hyaluronic acid, or collagen)

Use of injectable soft tissue fillers is considered medically necessary when both of the following criteria have been met:

1. There is documented evidence of significant functional impairment; and
2. The procedure can be reasonably expected to improve the functional impairment.

Use of injectable soft tissue fillers is considered reconstructive when there is a significant variation from normal related to any of the following:

1. Accidental injury; or
2. Disease; or
3. Trauma; or
4. Treatment of a disease or congenital defect.

Use of injectable soft tissue fillers is considered cosmetic and not medically necessary the criteria above have not been met, including when:

1. Performed in the absence of a significant functional impairment; or
2. Not reconstructive; or
3. Intended to change a physical appearance that would be considered within normal human anatomic variation (for example: lip enhancement procedures).