One Biologic's Path Forward: Market Positioning Under CMS' Updated Skin Substitute Definitions
With new CPT and J-code assignments pending, one company is navigating the 351 regulatory pathway and preparing a comprehensive educational strategy to help providers navigate a product’s clinical application and reimbursement landscape.
Key Takeaways
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These speakers share that the 351 approval process results in precise labeling, outlining eligible patients, wound characteristics, and usage parameters to support consistent, evidence-based clinical application.
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New reimbursement codes are underway, including a Category III CPT code with finalized language expected soon and a future J-code unique to biologics—distinguishing it from traditional skin substitute Q-codes.
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Provider education will be central to launch, ensuring clinicians understand not only procedural use of the product but also the reimbursement and coding differences compared with existing skin substitute pathways.
Transcript
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.
Nikolai Sopko, MD, PhD:
It will be very clear for providers specifically with SkinTE (autologous heterogeneous skin construct). And again, in part because the FDA has made it clear that our first indication is just going to be in Wagner 1 diabetic foot ulcers. And then typically with drugs and biologics going through this approval process, they look at our trial design, our trial criteria, and then that's what goes into the label. So it'll be pretty clear for providers in terms of using the product on label, who are the patients that it can be used on the wound types, the wound sizes and characteristics that will be pretty well spelt out. And then additionally, going through this 351 process, we already have gotten a category 3 CPT code. The language of that is still pending. That was just accepted in the fall of this year, just in October. So that final language will be coming out through the AMA process later this year, potentially as early as January. And then additionally, once you get fully approved, then you can apply for your J code, which is not a Q code that the skin substitutes get, but a J code, which is specific for biologics and drugs in general. And then that gets billed in addition to the CPT code. So we think because of this rigorous, very well-defined process that we've had to go through, that there'll be a lot of guidance for providers in how to use our product on that initial patient population.
Ned Swanson, MD:
I think to add on to that, as we look towards planning for the launch, everything we've just spoken about is going to have to be provided to the market, to providers through rigorous education. And that's not just how to use the product, how to do the procedures, but also all these reimbursement differences with SkinTE (autologous heterogeneous skin construct). So we've found the best results from the product come when there is great education, great training, the way you would expect with any new advanced products. So not only do we plan to rigorously train the market on how to do the harvest procedure, how to apply SkinTE (autologous heterogeneous skin construct) in the best possible way and offload it to ensure the best chances of success, but also to walk through all these differences in reimbursements and requirements that are going to be there with SkinTE (autologous heterogeneous skin construct). The overall structure with procedures and product codes being submitted won't be totally foreign to anyone just coming through this BLA pathway as a biologic. As Nick said, it's a J code. It's not a Q code new CPT codes, so not the CPT codes that have been getting used for skin substitutes, but ultimately the structure is very similar and we're planning to really work hand in hand very closely with all the first users of the product.
Dr. Sopko is the Chief Operating Officer and Chief Scientific Officer for PolarityBio.
Dr. Swanson is the President and Chief Medical Officer for PolarityBio.
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