Autologous Skin Cell Suspension Grafting Is Fundamentally Different From Skin Substitutes

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Dear Reader:

For those of you who perform procedures to help patients regenerate and close wounds—especially those using autologous or nonautologous tissue—this has been an interesting and, for some, turbulent time. Most of us are familiar with the fact that the US Food and Drug Administration (FDA) does not regulate procedures; it regulates products. This distinction becomes increasingly relevant when we use a patient’s autologous tissue. The question raised is whether using someone’s own skin, hair follicles, stem cells, platelets, whole blood, and similar materials constitutes a product or a procedure.

I asked my friend Lisa Gould, MD, PhD, to share her thoughts about one such procedure: autologous skin cell suspension (ASCS) application. Her expertise in this area is notable, and I always find her perspectives on clinical evidence, patient care, and physiologic pragmatism insightful. I invite you to read and consider this editorial, which addresses the importance of categorizing procedures as procedures—not as products.

John C. Lantis II, MD

Editor-in-Chief, Wounds

Patients with large full-thickness wounds, such as those following extensive burn injuries, necrotizing infections, giant congenital nevi, or massive hematomas, may benefit from nonautologous skin substitutes and dermal matrices that rapidly cover the wound to protect against infection, insensible water loss, and pain, without donor-site morbidity, as a first stage in wound reconstruction. However, these approaches are temporizing solutions and rarely allow complete epithelialization. As such, autologous skin grafting remains the gold standard for definitive wound closure. Although these approaches serve sequential roles in care and are not interchangeable, the distinction has blurred in payer coverage discussions.

The Centers for Medicare & Medicaid Services (CMS) defines nonautologous skin substitutes and dermal matrices as “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.”¹ Skin grafting techniques such as ASCS differ fundamentally from nonautologous skin substitutes in both composition and mechanism. Using a small split-thickness skin sample, a point-of-care device processes the patient’s viable skin cells into a suspension that is applied directly to the wound, enabling epidermal regeneration through cellular delivery rather than host repopulation of an implanted construct. In this system, the biological activity resides in the autologous cells themselves, not in a scaffold or matrix.

This distinction is clinically relevant across wound depths. In partial-thickness wounds, skin substitutes may support epithelial migration from wound edges, whereas ASCS delivers epithelial cells directly to the wound surface. In full-thickness wounds, dermal matrices may integrate into the wound bed but still require an epithelial source to complete closure. When used with widely meshed split-thickness skin grafts, the ASCS system supplies that epithelial component through delivery of the patient’s own cells. In both contexts, ASCS functions as an expanded autologous graft, minimizing donor-site requirements and directly contributing to epidermal regeneration, whereas skin substitutes still require an epithelial source to achieve complete closure.

Despite these differences, payers have grouped ASCS technologies—specifically the primary commercial system—into coverage policies developed for nonautologous skin substitutes.²^,³ This misalignment between biological function and policy classification can obscure clinical intent and undermine accurate value assessment. In practice, misclassification creates access barriers, including restricted coverage, delayed authorization, or denial. These barriers can translate into prolonged open wounds, additional operative procedures, increased donor-site morbidity, and extended hospital stays.

Notably, existing coding structures already recognize this distinction. Autologous skin cell suspension autografting is reported using Category I CPT codes specific to the ASCS procedure, separate and distinct from codes for skin substitutes or dermal matrices. Cost considerations further reinforce this separation, because per-area economics and episode-of-care implications differ from those of technologies that may require additional procedures to achieve epithelialization.

As acute wound care evolves, accurate classification is essential. Grouping autologous, epidermal cell–delivering grafting with nonautologous skin substitutes and dermal matrices may simplify policy development, but it undermines biological accuracy, clinical relevance, and patient access.

Autologous skin cell suspension grafting is not a skin substitute. It is a cell-based autografting approach for definitive closure and should be classified, evaluated, and covered accordingly.