Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. It is cleaned, sterilized and cryo-preserved or dehydrated and can be utilized to facilitate wound healing in diabetic and venous ulcers or sutured onto ocular surfaces.

Amniotic fluid contains a concentration of growth factors and nutrients that promote healing in soft-tissue repair of bone, tendon and cartilage, as well as reducing inflammation and pain, in conditions such as osteoarthritis and plantar fasciitis.

Treatment of nonhealing diabetic lower-extremity ulcers using ANY of the following HAM products may be considered medically necessary:

• AmnioBand® Membrane; or
• Biovance®; or
• Epifix®; or
• Grafix™.

Note: Nonhealing is defined as less than a 20% decrease in wound area with standard wound care for at least two (2) weeks.

All other HAM products and indications not listed above are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Sutured human amniotic membrane grafts may be considered medically necessary for the treatment of ANY of the following ophthalmic indications:

• Neurotrophic keratitis; or
• Corneal ulcers and melts; or
• Pterygium repair; or
• Stevens-Johnson syndrome; or
• Persistent epithelial defects.

Note: A persistent epithelial defect is one that failed to close completely after five (5) days of conservative treatment or has failed to demonstrate a decrease in size after two (2) days of conservative treatment. Conservative treatment is defined as use of topical lubricants and/or topical antibiotics and/or therapeutic contact lens and/or patching.

Sutured human amniotic membrane grafts are considered experimental/investigational and, therefore, non-covered for the treatment of all other ophthalmic conditions because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Human amniotic membrane without suture (e.g., Prokera®, AmbioDisk™) for ophthalmic indications is experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Injection of micronized or particulated human amniotic membrane is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Injection of human amniotic fluid is considered experimental/investigational and, therefore, non-covered for all indications because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.