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
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.