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Despite the incredible advancements in wound care and regenerative medicine, key agenciesincluding the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Agency for Healthcare Research and Quality (AHRQ)still lack a unified, standardized definition of what constitutes a "skin substitute." They actually rely on a list of surgical procedures to define products, The CPT manual, which explicitly states it does define products