Navigating CMS Skin Substitute Policy Changes: Thomas Serena, MD, on Access, Evidence, and the Future of Advanced Wound Care

• Recent CMS updates, including the December 15 update on the revised LCDs, will shift clinicians toward products on the covered or transitional lists, effectively redefining formulary decisions and limiting risk of claim denials.
• Reorganization of product classification and payment is driving changes in manufacturing trends, product sizes, and marketplace behavior, with potential downstream effects on mobile providers and access.
• Despite increased evidentiary requirements, the current regulatory pathway provides manufacturers time to complete clinical trials, and emerging pooled data will likely continue to strengthen support for skin substitutes—positioning 2026–2027 as a turning point for national coverage and consistency.

As CMS continues to refine payment and coverage policies for skin substitutes, clinicians and manufacturers alike are preparing for substantial shifts in product selection, reimbursement, and evidentiary expectations. In this interview, Thomas Serena, MD, shares candid insights on how the newest regulations may influence access, clinical practice, and the future landscape of advanced wound care.

I think the latest proclamation that came out (on December 15)¹ really puts providers in a much better position, at least for 2026. Because you're now going to choose products that are either on the covered list or on the transitional list. If you get a denial on the products that are on the, let’s call it the “naughty list,” since it’s the holidays, you won’t have any support to defend yourself.  So, as a clinician, I'm going to completely limit my use of these products to those on the approved or transitional lists.

One thing we know for sure is that there will be a lot of changes. There's also a lot of nuances in these decisions. For example, the changes to the professional fee schedule change the category from biologics to supplies.  This may not sound important but it can have wide ranging effects.  The products are now all lumped into one category.  If the skin sub is a supply then we no longer need to worry about wastage. The determination of price based on the ASP(average sales price) will no longer apply. 

So now, if you're a manufacturer, what you want to manufacture is a larger piece of tissue. If it's an “incident-to" product, then we don't record wastage anymore. So I think you'll definitely see companies, going to to cheaper products to produce, such as single-layer amnion, and larger product sizes, since that preserves some of the reimbursement that they lost.

Prior to December 15, I would have said it's going to create a lot of access issues, but there's enough products on the transitional list now that I don’t feel there will be access issues. I think the physician fee schedule payment rate which is $127.14, may put some of the mobile companies in a situation where their financial margins are lower. And, they may consider leaving the space. But, you know, back in the day, when we started doing in-home and nursing home care, we didn't even have CAMPs, and then when we did, we were super happy at a reimbursement around $127.

So, mobile companies can survive. They have the ability to. Whether they choose to or not is a different story, and some of them may choose to leave the marketplace. Thus, it may have an impact on patient access. But I think the way it landed on December 15, we won’t have significant access issues. It gives the companies that have really dedicated time, money, and a tremendous amount of effort another year to complete their clinical trials. The expectations were previously unrealistic. I think there are 27 trials running now, that can make the December 31, 2026 deadline.¹ So I am very confident that those currently transitional products could make the covered list in 2027.

We want to have evidentiary requirements. That's the way you're supposed to practice medicine. We're supposed to use the products that have the best evidence. So, the one thing I really must applaud Medicare for on this whole ordeal has been the evidentiary requirement. I think they have the timeline wrong on how long it takes to generate evidence. It takes time to generate good, robust evidence. But, in the same vein, we don't want to expose our patients to products that don't have efficacy.

Now, I will tell you that we're just in the process of publishing an analysis of all the trials on the diabetic side that we're doing. I think 12 companies participated, pooling all their data. It's an enormous database with almost 700 patients. We've never had a clinical trial in wound care that big. And, what we're seeing in our analysis is that one is overwhelmingly 

more likely to heal if you get a skin substitute as opposed to standard care. It's amazing results. We know these products work. Now we just have to have the time to demonstrate that they work. Not all the companies have decided to do clinical trials and generate evidence, and those companies will most likely go by the wayside. However, I don’t think that will impact access, nor will it really change our practice at all.

I think now, at the end of 2025, we've landed finally in a good spot after what has been two full years of tumultuous regulations and requirements. Everybody has a really good chance. Those that are dedicated to the field and are doing research have a really good chance of making it to the finish line now, in plenty of time.

The other thing that we'd like to see, and something that we're working on on the societal level is a National Coverage Determination (NCD). There are currently 7 identical LCDs (for DFU an VLU); that's very redundant. Why not have an NCD? I know Medicare's been very, I would say, accepting of that idea. So, there is a group of us now that, on a societal level, are going to propose that we move from LCDs to NCDs. I'd encourage everybody, all the readers to support. Maybe when we get to the Symposium for Advanced Wound Care (SAWC) in the spring, we can address it in person with everyone who attends, and everyone should attend this year. It's going to be a big year for everybody. So, this whole, idea of developing an NCD, I think, is a good one, and that'll make matters a whole lot easier.

Dr. Serena is the CEO and Medical Director of SerenaGroup.

1. Centers for Medicare & Medicaid Services. Upcoming update to the final Local Coverage Determinations (LCDs) for certain skin substitutes. CMS.gov. Published December 11, 2024. Accessed December 18, 2025. https://www.cms.gov/newsroom/fact-sheets/upcoming-update-final-local-coverage-determinations-lcds-certain-skin-substitutes