How CTP Changes Impact Providers, Patients, the Industry, and Policy

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 This content was created prior to that announcement and may reference policies that are no longer active.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.

This speaker discusses how CTP changes affect various stakeholders, how prepared providers will be, whether regulatory efforts are fostering or stifling innovation, and what policy actions would ensure sustainable growth and fair competition in the CTP sector.

• CMS (US) — 2026 skin substitute reimbursement: Non-facility (office) providers may face reimbursement limitations, while hospital outpatient departments will again receive separate product reimbursement rather than packaged payment.

• Patient access considerations: Care may shift from office to outpatient facility settings; LCD coverage limits (effective Jan 1, 2026) on number of applications may restrict or appropriately standardize treatment, with mixed industry opinions on access impact.

• Preparation and compliance: LCD and payment updates have been publicly available for >1 year, enabling readiness; clinicians should follow coverage rules, document exceptions clearly, and use the CMS appeals process for atypical, medically necessary cases.

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. 

How do you feel these changes may impact providers? What about patients or industry?

There is a varying degree of impact for providers and for patients. It depends on the setting. Some of the specific or profound changes with the 2026 skin substitute changes will likely be seen in in the provider’s setting or the non-facility office setting. We also will appreciate some changes in the outpatient setting as well but in a different perspective. So the impact of providers will certainly vary for the non-facility and the facility setting. Likely the way skin substitute products will be reimbursed will be impactful to both. In the provider setting there might be what providers feel is a little more of a limitation as far as reimbursement. And on the facility side, for the first time in a number of years the facility will actually appreciate reimbursement for the products and as it was no longer going to be packaged with the application code. 
 
For patients it’s a little bit different. There may be a little bit of s shift in where care is render. If providers in the non-facility setting are less inclined to do it in their office there may be a little bit if a move to the outpatient setting. So by and large patients should be able to get the care their need in either setting regardless of those changes in reimbursement. What may be impactful to patients are the specific coverage guidelines as laid out in our Local Coverage Determinations going into effect January 1, 2026. There is some thought that with the limit on the number of applications, some in our industry are of the opinion that patients may be limited or restricted to needed care and yet we have others speaking to the appropriateness of limitations on skin substitute applications in that they are useful based on that limited number of applications. So it’s a little bit of a mixed opinion among most of the people I’ve spoken with in the industry about whether or not that will limit or impede access to patient care. 
 
What is your sense of the preparedness of provider community for these changes?

Based on what we’re doing in our own organization and based on what we see in the industry, everyone should be well prepared for these changes in the provider office setting or non-facility setting as well as in the outpatient hospital facility setting. There is a good bit of information that’s been circulating for quite some time. The LCDs, for example, were originally meant to go into effect in February of 2025. That was postponed to April and then once again postponed to 01-01 of ’26. So the coverage changes have been out there for awhile. We should be very well prepared for expected coverage changes. 
 
The reimbursement changes we’ve also been pondering for about six months when they were first published in the proposal over the summer. And happy to see that the consistency between the proposed rule and the final rule is basically the same. Whether we agree or disagree with the final outcome, it was pretty consistent with what was proposed. So as far as being prepared, I would expect all of us in the industry to have a good knowledge about what's going to go into effect on January the 1st.  

Do you believe current regulatory efforts are fostering innovation or stifling it? 

Off the cuff, I would say it's fostering innovation as there are different degrees of, or levels of FDA approval and what the products originate from, it seems that there could be additional innovation and through further clinical trials on how the products are created and developed would, I think would foster some innovation. 
 
I don't feel like it's stifling it. If there were to be any concern about stifling it, it may be more of the specific coverage as it related to the different categories or origins of all of the skin substitute products that we look at. I think using the different degrees of FDA approval will certainly keep it level in the products types, product origins that we’re not lumping products made from human-based tissue versus other types of tissue. So I think it will, and again, just a general observation, I would be of the opinion that it should ensure sustainable growth as the development of each type of product is further researched, further expanded and could again allow for very specific classifications of each of the CTP types of products. And I think once that is fully in place, cataloguing or categorizing them by the origin of their makeup, if you will, will allow others to see where’s the best area of growth and development as well. That they’re all not lumped together as one type of product. 
 
What policy actions would most help ensure sustainable growth and fair competition in the CTP sector?

I think it’s important that we do appreciate the reimbursement changes. Like I said, the coverage guidelines have been out for over a year. I know there’s still a fair amount of debate on those. I think that with the opportunity to navigate through the appeals process, just like other changes we’ve made with CMS, it’s following the guidelines, knowing when there’s exceptional cases or exceptional patient care that might require to exceed those guidelines, we have the appeals process at our disposal. And through that appeals process if we’re successful getting things recognized and processed and paid, I think that’s how we move the needle with CMS. We’ve seen that approach in other areas like MUEs and frequency guidelines. 
 
So I think it is important that when we do have unusual patient care circumstances, that we've followed the guidelines of the coverage of the LCD, but that our documentation is clear. And supporting the need to go beyond that, we have the documentation in place. It's clear and concise, and we use that to navigate through the appeals process.