Corplex is a human umbilical cord allograft obtained from donated human birth tissue through the retention of both the epithelial layer and the Wharton's jelly.
INTENDED USES: The allograft is specifically intended to be used as a wound covering or barrier membrane over chronic and acute wounds.
CLAIMED BENEFITS: The sheet is processed using the Clearify process to maximize the retention of desired structural components. This process is designed to retain a thick structure optimized for use as a wound covering for deep and challenging wounds. Corplex retains key extracellular matrix components, including collagens and proteoglycans that provide a robust matrix. The product is then dehydrated, cut into various sheet sizes and presented in a dehydrated graft form and packaged as separate, individual units and terminally sterilized. The allograft only contains non-viable cells that were present at the time the tissue was donated. It is minimally manipulated and intended for homologous use only. The function of Corplex is for repair, reconstruction, replacement or supplementation of the recipient's tissue.
OPTION: The route of administration is topical and is supplied as 15 mm, 2 x 2 cm, 2 x 3 cm and 3 x 5 cm sheets. Corplex is supplied in sheet form in a sterile inner pouch. The inner pouch is inside a non-permeable outer pouch contained in a carton. It should be maintained in its original packaging and stored at ambient temperature (0C to 38C) until ready for use. When stored properly Corplex allografts are shelf stable for up to 5 years. According to the applicant, no existing code appropriately defines Corplex.
The addition of Skin Substitutes or Cellular or Tissue Based Products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing, after at least a 30 day period of comprehensive conservative therapy. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. • Human skin allografts are derived from donated human skin (cadavers) • Allogeneic matrices are derived from human tissue (fibroblasts or membrane) • Composite matrices are derived from human keratinocytes, fibroblasts and xenogeneic collagen • Acellular matrices are derived from xenogeneic collagen or tissue
For Medicare to cover this product, it needs to be ordered and applied by your clinician. A patient cannot purchase it directly from a Durable Medical Equipment (DME) store and receive reimbursement for it.
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