Is TheraSkin FDA approved?

TheraSkin, of course, meets or exceeds the stringent testing and processing requirements set by the American Association of Tissue Banks (AATB) and the Food and Drug Administration (FDA).

What does TheraSkin cost?

Summary of indications and efficacy of cell-based wound dressings

Product	Type of biological dressing	Cost
NEOX Wound Allograft	Cryopreserved human AM/UC	N/A
OrCel	Bilayered cellular matrix	Still et al. US $27.80/cm2
Theraskin	Cryopreserved human skin allograft	Eligible for Medicaid & Medicare coverage

What is TheraSkin used for?

TheraSkin is a unique skin allograft because it can be used on chronic wounds where there’s exposed bone, tendon and muscle. These qualities make it suitable for treating a variety of chronic wounds, including diabetic ulcers, venous stasis ulcers, traumatic burns and surgical wounds.

Is TheraSkin cadaver skin?

Another skin substitute on the market is a cryopreserved cadaveric skin allograft (CCSA, TheraSkin; Soluble Systems, Newport News, VA). CCSA is a human skin allograft harvested from tissue donors within 24 h of death.

What is TheraSkin made from?

What is TheraSkin? TheraSkin is an all human bioactive split thickness skin allograft with living cells, growth factors, and a native extracellular matrix.

How do you bill TheraSkin?

HCPCS code Q4121 for TheraSkin, per square centimeter as maintained by CMS falls under Skin Substitutes and Biologicals.

Are skin grafts covered by Medicare?

Application of a skin substitute graft for lower extremity chronic wounds (diabetic foot ulcer and venous leg ulcer) will be covered when the following conditions are met for the individual patient: ▪ All products with FDA clearance/approval or designated 361 HCT/P exemption used in accordance with that product’s …

Who makes Dermagraft?

Smith & Nephew and Advanced Tissue Sciences created their DERMAGRAFT◊ joint venture in 1996, and made a PMA application for DERMAGRAFT◊ in 1996.

Does insurance cover skin grafts?

The price tag attached to a skin graft will depend on the extent of your injuries, the skill and experience of your attending surgeon, any health insurance discounts you may receive, and what methods are used.

Does Medicare pay for allograft?

Q: Does Medicare cover placement of an amniotic tissue allograft? A: Yes, when medically necessary. Check the payer’s coverage policy for additional limitations.

Does insurance cover AlloDerm?

You may be eligible to receive free AlloDerm if you: Will have a medically necessary surgery that requires the use of AlloDerm. Apply for patient assistance prior to your surgery. Have no health insurance coverage or your insurance will not cover AlloDerm.

What is dermagraft made of?

Dermagraft contains only human dermal fibroblasts and their secreted products and is devoid of other cell types also found in skin (e.g., macrophages, lymphocytes, endothelial cells, or keratinocytes). The fibroblasts are from a qualified cell bank and have been extensively screened for infectious agents.