Cutting Costs, Raising Standards: The Case for Evidence-Based CTP Use

Disclaimer: On December 24, 2025, CMS withdrew the final LCDs for certain skin substitutes. This content was created prior to that announcement and may reference policies that are no longer active. Much of the information remains applicable under other current or future regulations. Always consult your local MAC or payor policies for the most up-to-date guidance.

CMS reimbursement reforms are reshaping the use of skin substitutes in wound care, phasing out high-cost, low-evidence products in favor of therapies backed by rigorous clinical data. New models like WISeR promote prior authorization to ensure appropriate, evidence-based use of these advanced treatments.

• Dr. Regulski share that high-ASP, low-evidence skin substitutes are being phased out, with CMS reimbursement cuts driving the shift toward cellular products supported by high-quality RCTs.
• New policies promote evidence-based wound care, encouraging proper tissue preparation and the use of products with proven 12-week healing efficacy and substantial follow-up data, according to the speaker.
• Dr. Regulski also believes that the WISeR model will help ensure clinical appropriateness and reducing the use of grafts without proper standard-of-care compliance.
• Market consolidation is expected, in the speaker’s estimation, with CMS changes likely to eliminate poorly supported graft products while preserving reimbursement viability for clinically validated solutions.

Please note: This content is a direct transcript, capturing the authentic conversation without edits. Some language may reflect the flow of live discussion rather than polished text. 

Well, I think as a physician, it's not going to affect our practice. I mean, people are not going to be using these higher ASP ones, obviously. And I think it's a good thing. I think they've been overutilized nefariously in several different circumstances and in instances. Cutting the price down, they had to. I mean, you go from $200 million to $15 billion a year in a couple of years, it was crazy. So I don't know. It's not going to affect my use because now to be honest with you, I like cellular products better than the non-living dead ECM ones that are out there, because a lot of the living products, Grafix®, Apligraf®, Dermagraft®, they have very high level RCT data to prove that they can actually work. Let's be honest, people were just using these other tissues just because they had ridiculously high ASPs. They had no proof. They had no testing to show they could actually heal in a 12-week period. They just had these very high ASPs, and people were using it, making millions of dollars on it needlessly. So, I'm glad it came through.

Now, the part that concerns me being that they dropped the price down so much, there's a lot of companies that may have to go out of business, and people get fired because of that. I think they could have simply cut it down to $700-800 a square centimeter. And still, companies could have flourished. Everybody would've been happy, and they would've saved a tremendous amount of money anyway.

Well, I mean, obviously a lot of these are not going to be covered, because they don't have high RCT data to them, but also they're just going to cut the price down on them as well, which will get rid of a lot of clutter, so to speak. So, I'm sure there's going to be several different companies and their grafts and their unfounded grafts. With 212 skin substitutes on the market, it's ridiculous. And if you look at the new LCD coming through, they did talk about they have a 12-month status-quo period where you can submit data and have reconsideration to be on one of the covered formularies. But I think we're definitely going to weed out a lot of these grafting tissues that just had high ASP and no evidence.

With the WISeR model that they're going to test out in 6 states where you have to get prior authorization, we might even see different wound types that get approved for use of this, of using grafting. If you had some kind of a collagen vascular disorder or radiation, more burns. Now, with the WISeR model, which the waste of inappropriate services provided, I think it might be a good thing to have prior authorization because that's the right thing to do, to make sure that they've gone through a complete checklist of good standard of care to prep your tissue. As I always like to say, prepare to repair, that model that I put forth and published about, all those good things you need to do to get the tissue prepared to repair itself. Because something's always missing in that paradigm anyway. So I think it is going to be good for the whole business.

I think, to be honest with you, I'm thinking that maybe after Q1, they're going to raise—I think perhaps they might look at it again and raise it because of the lobbying and lobbyists that are going on, saying that people are going to be affected, jobs are going to be affected. And I think they could certainly raise it up to $500-600 and still save a gazillion dollars, but still yet provide enough revenue for, I guess, some of these companies to stay in business, so to speak.

But I think this was well needed. This was welcomed. I welcomed it, because there had to be some better oversight, scientifically, evidentially, evidence-based medicine, do your RCTs, prove that you can actually heal in a 12-week, have a substantial follow-up period, do all the good things that you've been taught to do to prepare your tissue to repair, and you still have a whole list of formulary to put stuff on.

Dr. Matthew Regulski, DPM, FFPM, RCPS (Glasgow), DABMSP, is a board-certified podiatric physician and a nationally recognized expert in wound healing and regenerative medicine. He is known for his clinical leadership in evidence-based wound care and for advocating responsible, outcomes-driven use of skin substitutes.