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:

• Affinity®; or
• 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 for the treatment of non-healing diabetic lower-extremity ulcers not meeting the criteria as indicated in this policy 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.

Treatment of non-healing venous stasis ulcers using Grafix may be considered medically necessary when BOTH of the following criteria are met:

• Partial- or full-thickness venous stasis ulcer of greater than four (4) weeks duration for which standard wound therapy has failed; and
• Treated lower extremity has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of greater than or equal to 0.70

When the above medical necessity criteria are met, the following conditions of coverage apply:

• Treatment is limited to one (1) initial application
• Additional applications at a minimum of (1) one week intervals, for up to a maximum of four (4) in 12 weeks are considered medically necessary when evidence of wound healing is present (e.g., signs of epithelialization and reduction in ulcer size)

Quantity of treatments that exceed the frequency guidelines listed in this policy are considered not medically necessary.

All other HAM products for the treatment of venous stasis ulcers not meeting the criteria as indicated in this policy 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 HAM 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 HAM grafts not meeting the criteria as indicated in this policy 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.

Human amniotic membrane (HAM) grafts without suture (Prokera®, AmbioDisk™) may be considered medically necessary for the treatment of the following ophthalmic indications:

• Neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy; or
•  Corneal ulcers and melts that do not respond to initial conservative therapy; or
• Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment; or
• Bullous keratopathy as a palliative measure in individuals who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty); or
• Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient; or
• Moderate or severe Stevens-Johnson syndrome; or
• Persistent epithelial defects that do not respond within two (2) days to conservative therapy; or
• Severe dry eye (DEWS 3 or 4) with ocular surface damage and inflammation that remains symptomatic after Steps 1, 2, and 3 of the dry eye disease management algorithm; or
• Moderate or severe acute ocular chemical burn.

Human amniotic membrane without suture for ophthalmic indications not meeting the criteria as indicated in this policy is 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.

All other HAM products not meeting the criteria as indicated in this policy 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.

The following are 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 micronized or particulated human amniotic membrane; and
• Injection of human amniotic fluid.