Corplex

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Corplex, per square centimeter

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.

Product Information

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

Pricing and Suppliers

Is it covered by Medicare Part B?

Medicare covers the application of Cellular and Tissue Based Products (CTPs) for chronic Wounds, which are defined as wounds that do not respond to standard wound treatment for at least a 30 day period during organized comprehensive conservative therapy. Medicare has guidelines that establish what is considered medically necessary and how often an item can be used.

How can I purchase this product?

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.

The table below shows highest and lowest Medicare pricing across the country

Description	Medicare DME co-payment Min / Max
	$0.00 / $0.00

Estimated out-of-pocket cost:

If your insurance does not cover this product, you can purchase it directly from any store. A list of online stores and prices is provided below for your convenience. For updated prices, find it on the internet at https://woundreference.com/app/product?id=3394

Other Stores

* Indicates whether store accepts Medicare or commercial insurance, but may not apply to this specific product. See coding, coverage and reimubursement for more information.

The information on this handout is for your convenience and educational purposes only. All product claims and specifications are those of the product suppliers. It does not constitute medical advice or a guarantee for reimbursement. Prices may have changed and suppliers may not have product in stock. Please confirm accuracy and appropriateness of information with insurance carrier and product supplier. Clinician and WoundReference assume no liability for inaccuracies or misstatements about products and insurance coverage.