I had a great time speaking at the WOCN conference in Orlando! I was asked to provide an update on “Skin Substitutes.” I will give you a few highlights from the talk. I reviewed the reasons we need skin substitutes, such as the huge percentage of patients suffering from chronic wounds/ulcers in the Medicare population alone (>16% based on Medicare claims, and I provided a few data highlights which came in part from the analysis of US Wound Registry (USWR) data that is still being prepared for publication but was recently presented at the Spring SAWC in the wonderful event hosted by the Wound Care Collaborative Community. Based on our recent analysis, most chronic ulcer patients have more than one concomitant wound/ulcer and often more than one “type” of wound. For example, 13% of patients with a Diabetic foot ulcer (DFU) have a Venous Leg Ulcer (VLU) and 17% of patients with a VLU have a DFU. It seems likely that chronic wounds/ulcers are actually a symptom of chronic disease. More than 40% of VLU patients have diabetes. Among patients with diabetes, 41.6% had a venous ulcer. When we looked at DFU and VLU patients, the overlap of their chronic diseases (and their medications) was astounding, About 60% of both DFU and VLU patients were obese, about a third of both have peripheral arterial disease, and around 15% of both groups have a diagnosed autoimmune disease! That may explain why honestly reported healing rates are much less than wound centers brag about the low “honest” healing rates (perhaps as low as 50%). That’s why we need advanced therapeutics!

Although payers (both private and Medicare) want to use published prospective, randomized, clinical trials (RCTs) to craft coverage policy, nearly all prospective RCTs of CTPs/CAMPs are highly “non-generalizable” (meaning, not relevant to actual patients). That’s because nearly all studies enroll only superficial and relatively small ulcers, and nearly all exclude patients with serious comorbid diseases. Based on a recent analysis of USWR data, only 8% of DFU patients could have participated in any prospective trial of “skin substitutes” performed in the past 20 years (one recent DFU trial is a big exception). Payers use RCTs to create coverage policies that may not “make sense” in real patients – e.g., the severity of ulcers to be treated, how many CTP applications are needed, over what time frame, etc. However, coverage policies establish the standard of care that should be met before advanced therapeutics can be used. Tragically, USWR data show that adequate compression is still being performed in only 20% of VLU-visits – no improvement since our original study 15 years ago.

A recent New York Times article discussed the fact that in 2024, $10 billion dollars were spent on “skin substitutes” (compared to $1.4 billion in 2023), and the continued increase in price per cm2 means that 2025 spending will far exceed that. CMS has had to expand the monetary amount fields to accommodate individual claims of $99,999,999,99. There is no evidence to support that more expensive products work better, and based on potential “cost savings,” until different data are available, it is not possible to justify products that cost more than $350/cm2 for DFUs (at least the superficial ones that are included in trials). (Perhaps the cost effectiveness story is different for more severe DFUs and pressure ulcers – which is where we need better data).

I discussed the way that Cellular and/or tissue-based products (CTPS)/CAMPs (or whatever it is we are going to call them) come to market, and how that impacts the claims that can be made about them What Claims Can an Amniotic “Skin Substitute” Sales Rep Make? – Caroline Fife M.D.. (There are only two products that can make actual claims to “healing” an DFU or VLU. No other product can make claims that they improve healing!). I talked about why there has been a dramatic increase in both the use and the cost of CTPs/CAMPs/skin substitutes, about the potential moral hazard associated with their use, and the even scarier legal hazard. You searched for skin substitutes – Caroline Fife M.D.

There are differences in the use of CTPs/CAMPS (and the prices of the product used) based on where the practitioner is working. CTP/CAMP use in the Hospital-based outpatient department (HOPD) is primarily in DFUs, whereas in the Mobile/Office, it is in Pressure Ulcers. A higher percentage of ulcers of all types are treated with CTPs/CAMPs in the Office/Mobile setting. Interestingly, based on CodeMap® data, more than 27% of 2022 claims for CTPs/CAMPS were billed by nurse practitioners, which may explain why two NPs were caught up in the Department of Justice action around the Apex Mobile Medical indictment.

Lots of things can be true at the same time. Our patients are sick, their wounds are hard to heal (and they have more than one wound/ulcer), healing rates are lower than we pretend they are, advanced therapeutics are needed and valuable, we do a poor job of basic care (e.g., offloading, compression, arterial assessment, etc.), the prices of products are increasing rapidly, we don’t have the data we need to understand cost effectiveness, and most prospective trials are not relevant to the real world. I will add that most of the current problems and questions can be solved/resolved with data. Thank you to the WOCN planners for asking me to speak about this controversial topic!

Caroline Fife, M.D.

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.