United Healthcare has issued a commercial coverage policy for “Skin and Soft Tissue Substitutes” effective August 1, 2025, which limits the use of “skin substitutes” ONLY to diabetic foot ulcers (DFUs) — and which covers ONLY EpiFix or Grafix® (GrafixPL, GrafixPRIME, GrafixPL PRIME). (TranCyte is covered for burns.) United Healthcare may cover about 29 million people in the USA, not including their Medicare Advantage plans. (I will address their Medicare Advantage policy for skin substitutes separately but you can find it here: Skin Substitutes Grafts/Cellular and Tissue-Based Products (Injections and/or Applications) – Medicare Advantage Medical Policy)
There are some interesting things in the UHC Commercial coverage policy such as:
- It specifically does NOT cover CTP/skin subs for all other wound types
- It picks only TWO manufacturer’s products
- It allows up to 12 applications (“once per week for up to 12 weeks”)
- It specifically does NOT cover ulcers that extend to tendon, muscle, capsule, or bone
The policy has some language that is similar to the still on hold MAC LCD(s), such as the requirement for 4 weeks of failed standard of care (SOC) before using a skin sub. The SOC definition includes confirmation of adequate circulation – which can be done by stating that pulses are palpable (!), a Hemoglobin A1C <12%, moist wound care, debridement and offloading. Specific “contraindications” to the use CTPs/skin substitutes include: “major structural deformities” of the foot, chronic infection of ulcer site, malignancy in the wound, and extension of ulcer to deep structures. The policy includes a literature review which is notable for omitting some prospective RCTs of other products.
The other part of this policy that is interesting is the way that UHC classifies CTPs/skin subs. Since the experts can’t agree on terminology it is not surprising that payers can’t figure it out. The ASTM approved term “Cellular and/or tissue-based products (CTPs)” (which ought to be the standard until such time as ASTM changes it) is not used, nor is the term CAMP. Instead, it references a 2023 article from the Indian Journal of Plastic Surgery (Kumar P, Gupta A. Updated classification of skin substitutes. Indian J Plast Surg. 2023 Jul 28;56(4):388-389) which I have never seen, suggesting that there are 3 classes of products. The classification is based on whether they are “temporary” (which uh, would be all of them), whether they are impervious (what?), whether they are single layer “durable” (again, what?), or composite. This might be most clinically and scientifically useless classification system imaginable for these products, but since you have read this far, you might as well see it, just to understand how chaotic things are:
Class 1 Skin substitute:
- Temporary impervious dressing materials without negative pressure
- Single-layer material:
- Naturally occurring membrane/cover as biological dressing substitute, for example, amniotic membrane, potato peel
- Single-layer synthetic skin dressing material substitute, for example, synthetic polymer sheet
- Bi-layered tissue engineered material
- Single-layer material:
- Temporary impervious dressing materials with negative pressure, for example, LAD without interface material like sponge used in vacuum-assisted closure therapy. Under LAD collection will be removed by negative pressure and also, it will prevent/clear infection leading to healing or requiring further surgical intervention for healing.
Class 2 Skin substitute – Single-layer durable substitutes:
- Epidermal substitutes
- Dermal substitutes (bovine collagen sheet, porcine collagen sheet, bovine collagen matrix)
Class 3 Skin substitute – Composite skin substitutes:
- Skin graft (allograft-cadaver Xenograft-pig)
- Bioengineered skin
No doubt UHC will get a few letters from other manufacturers about this policy, but none of that is likely to be public. In summary, this large private payer has a “winner takes all” policy for CTPs that makes the still-on-hold LCDs look generous. Later I will discuss the United Healthcare Medicare Advantage plan for “skin substitutes” for others like me who desperately need a hobby.
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
