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Amniotic Membrane and Amniotic Fluid

Treatment of nonhealing diabetic lower-extremity ulcers using the following human amniotic membrane products (Affinity®, AmnioBand® Membrane, Biovance®, EpiCord®, EpiFix®, Grafix™) may be considered medically necessary.Human amniotic membrane grafts with or 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;

Corneal ulcers and melts that do not respond to initial conservative therapy;

Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment;

Bullous keratopathy as a palliative measure in patients who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty);

Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient;

Moderate or severe Stevens-Johnson syndrome;

Persistent epithelial defects that do not respond within 2 days to conservative therapy;

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 (see Policy Guidelines); or

Moderate or severe acute ocular chemical burn.

Human amniotic membrane grafts with suture or glue may be considered medically necessary for the treatment of the following ophthalmic indications:

Corneal perforation when corneal tissue is not immediately available; or

Pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft.

Human amniotic membrane grafts with or without suture are considered investigational for all ophthalmic indications not outlined above.

Injection of micronized or particulated human amniotic membrane is considered investigational for all indications, including but not limited to treatment of osteoarthritis and plantar fasciitis.

Injection of human amniotic fluid is considered investigational for all indications.

All other human amniotic products (eg, derived from amnion, chorion, amniotic fluid, umbilical cord, or Wharton’s jelly) not listed above are considered investigational (see policy guidelines).

All other indications not listed above are considered investigational, including but not limited to treatment of lower-extremity ulcers due to venous insufficiency and repair following Mohs micrographic surgery.

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