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Cellular and/or Tissue Products

CLINICAL

Overview

Cellular and Tissue Based Products (CTPs) or Bioengineered Skin Substitutes, referred to as Skin Substitutes by CMS, The Current Procedural Terminology (CPT) and The Healthcare Common Procedure Coding Manuals, have been developed in an attempt to circumvent problems inherent with autografts, allografts and xenografts. These constitute biologic covers for refractory wounds with full thickness skin loss secondary to 3rd degree burns or other disease processes such as diabetic neuropathic ulcers and the skin loss of chronic venous stasis or venous hypertension. The production of these biologic skin substitutes or CTPs varies by company and product, but generally involves the creation of immunologically inert biological products containing protein, hormones or enzymes seeded into a matrix which may provide protein or growth factors proposed to stimulate or facilitate healing or promote epithelization. A variety of biosynthetic and tissue-engineered skin substitution products marketed as Human Skin Equivalents (HSE) or Cellular or Tissue-based Products (CTP) are manufactured under an array of trade names and marketed for a variety of indications. All are procured, produced, manufactured, processed and promoted in sufficiently different manners to preclude direct product comparison for equivalency or superiority in randomized controlled trials. Sufficient data is available to establish distinct inferiority to human skin autografts and preclude their designation as skin equivalence. [1]

Bioengineered skin substitutes or CTPs are classified into the following types:

  • Human skin allografts derived from donated human skin (cadavers)
  • Allogeneic matrices derived from human tissue (fibroblasts or membrane)
  • Composite matrices derived from human keratinocytes, fibroblasts and xenogeneic collagen
  • Acellular matrices derived from xenogeneic collagen or tissue

CODING, COVERAGE AND REIMBURSEMENT




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REFERENCES

  1. Novitas Solutions, Inc. et al. Local Coverage Determination (LCD): Application of Bioengineered SKIN SUBSTITUTEs to Lower Extremity Chronic Non-Healing Wounds (L35041) . Date of publication 2015;volume ():.

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