Description

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.

Criteria

Human amniotic membrane (HAM) forms the innermost layer of the placenta and is harvested from the time of caesarean section. Treatment of non-healing 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 for the treatment of non-healing diabetic lower-extremity ulcers 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.

Procedure Codes

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 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.

Procedure Codes

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

Procedure Codes

All other HAM products  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.

Procedure Codes

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.

Procedure Codes

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes Q4132, Q4133, Q4151, Q4154, Q4168 and Q4186

*L97.xxx codes must be billed with one of the following Exx.xxx codes from this section: 

Covered Diagnosis Codes for Procedure Codes 65779, Q4100 and V2790

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