REGUaRD is an HCT/P donated allograft placental membrane tissue.
INTENDED USE: REGUaRD is a hydrated acellular (human) dermal allograft matrix used for the treatment of non-healing wounds and bum injuries.
CLAIMED BENEFITS: REGUaRD contains extracellular matrix (ECM) that provides a scaffold for cellular ingrowth vascularization, tissue regeneration and formation of granulation tissue.
OPTION: REGUaRD is supplied as a thin (0.5mm) allograft, in a variety of sizes. REGUaRD may be cut and shaped to the appropriate size. Existing codes are not applicable as they are identified by specific branding. REGUaRD is administered by a health care professional in a physician's office, outpatient surgery center, or acute care facility. The size is determined by the injury or wound. REGUaRD is packaged in multiple sizes and stored at ambient temperatures.
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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