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Product Type: Human Skin Allografts
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Soluble Systems, LLC | |
HCPCS : Q4121 (Medicare DME co-payment per billable unit min / max: $0.00 / $0.00)
TheraSkin is a biologically active, cryopreserved human skin allograft.
INTENDED USES: TheraSkin may be used in diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. It is esigned to promote wound healing by providing cellular and extracellular components with growth factors, cytokines, and collagen and to be a natural barrier to infection.
CLAIMED FEATURES: Composed of living cells, fibroblasts, and keratinocytes and a fully developed extracellular matrix. Does not contain any synthetic or animal materials.
Wound Reference does not produce, market, re-sell or distribute health care goods or services consumed by, or used on, patients.
Composition: Animal-derived
Composition: Human dermis with/without epidermis
Composition: Human placenta or umbilical cord
Composition: Viable (living) cells
Configuration: Fenestrated/ meshed
Configuration: Flowable
Configuration: Sheet
May apply on full-thickness wounds
May apply over exposed tendon/ bone/ muscle
May apply over infected tissue
Processing: Cryopreserved
Processing: Decellularized or irradiated
Processing: Dehydrated
Processing: Fresh (limited shelf life)
Processing: Hydrated
Processing: Minimally manipulated
Shelf life: Greater than 2 years
Storage: refrigeration needed
Storage: room temp

Application of Skin Substitutes (also known as Cellular and/or Tissue Based Products) to certain wounds may help these wounds heal faster than conventional dressings and conservative treatments. Usually skin substitutes are used if conventional treatment has been tried for at least 30 days and the wound has not healed as quickly as expected. Human skin allografts are a type of skin substitute. They are made of skin donated by human donors that have had intact cells removed or treated to avoid immunologic rejection (a process in which the body of the person receiving the skin substitute kills the cells of the skin substitute).

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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