Subscribers to CMS (Centers for Medicare and Medicaid Services) listservs recently got a very short email announcing that CMS is reopening the call for clinical evidence on skin substitutes. I’d provide a link to the bulletin – but there isn’t one! It was simply a low-key, e-blast. Here is the operative sentence, verbatim: “CMS invites product sponsors, manufacturers, researchers, and other interested parties to voluntarily submit full-text clinical evidence relevant to the medically necessary use of these products in the Medicare population.” Submissions go, as PDF attachments, to CAGInquiries@cms.hhs.gov — the mailbox for the Coverage and Analysis Group.
Who’s Asking?
You may be wondering exactly who is asking. The CMS Coverage and Analysis Group (CAG) is a division within the Center for Clinical Standards and Quality (CCSQ) responsible for leading the evidentiary review process for all clinical topics related to Medicare coverage. Part of the CAG’s job is to identify relevant studies, evaluate their quality, and synthesize findings. Thus, the CAG plays a central role in developing both National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs). The CAG has several divisions including the Division of Policy and Evidence Review that leads evidence review, policy development, and oversight of NCDs and emerging technologies, and the Division of Policy Coordination and Implementation that oversees LCD processes and NCD implementation. In short, the CMS CAG is the agency’s central hub for evidence-based Medicare coverage decisions for both NCD and LCDs.
Why is the CAG Asking for CTP/CAMP Evidence?
The most interesting question is “why is the CAG asking?” The notice says that CMS “has heard from several manufacturers and product sponsors that they did not have sufficient time to submit clinical information during the previous review period,” and is therefore “providing an additional opportunity for submissions.” That means that this is the same skin substitute evidence review that has been running alongside the LCD saga. Remember the draft LCDs proposed by every regional MAC included a list of “covered and uncovered” skin sub products. A big criticism about the evidence included in the LCDs was that the published studies were highly variable in quality (and that the evidence review entirely missed some important publications). Manufacturers complained loudly and in response to their complaints, the MACs allowed the submission of additional published evidence with a deadline of October 31, 2025. However, since the LCDs were subsequently withdrawn, there is currently no official Medicare list of “covered” CTPs/CAMPS. In retrospect, it’s been suggested that the original covered list was created in part to deal with rapidly increasing CTPs prices in the absence of published evidence about those expensive products. If that was the case, one could argue that the CMS decision to set a fixed price per cm2 made a future “covered” list less likely. However, the recent email notice from CMS opening the opportunity to submit evidence might imply that there is a move afoot to craft new LCDs – or even an NCD – around CTPs/Skin subs.
There’s another issue which may be unrelated to this request from the CAG, but is important to note. Medicare claims for skin sub treatments are being denied by MACs on the grounds that products are “experimental” if there are no published studies to support their use in wound healing. Michael Crouch warned us about this in October of 2025 in his guest post, “The Incredible Journey: Lessons Learned from a “Skin Substitute Graft” Audit – Part One”. In the case he detailed, the Administrative Law Judge (ALJ) eventually refuted that determination by the MAC as a reason for denial – but many of you have emailed me to tell me that you have lost your appeal at the ALJ level on the basis that a skin sub product was “experimental.” One well known individual who has provided expert testimony to the ALJ on behalf of several clinicians told me, “If there are no published studies for a product, there’s not a lot of hope for overturning the ‘experimental’ issue in an audit.” (Personal communication, name withheld). In other words, the possibility of a future draft LCD or NCD is not the only reason for manufacturers to submit published data on their product(s) to CMS.
The Bar for CTP/CAMPs Evidence
What makes this even more interesting is that CMS points readers to the November 2025 consensus, Clinical Trials for Cellular, Acellular, and Matrix-Like Products (CAMPs): An Evidence Consensus, “which provides guidance for identifying high-quality clinical evidence.” If there is a move afoot to craft new NCDs or an LCD, a “voluntary” invitation to submit evidence should be taken as more than just a suggestion. Interestingly, this invitation from the CAG to submit evidence does not provide a deadline — it’s framed as an open “additional opportunity.”
CMS wants peer-reviewed publications and other high-quality, publicly available information, submitted as PDFs to CAGInquiries@cms.hhs.gov.
Additional Information:
Check out this amazing work by Zweli Tunyiswa and colleagues analyzing the CTP/CAMP studies for DFUs.
