Avoiding Audits and Making Sure You Get Paid

• Medicare, skin substitutes/CTPs (US outpatient setting): Clinicians report payment denials by Medicare auditors, particularly for amniotic products, citing lack of FDA approval—described in the transcript as an invalid basis for denial and observed more often with high-priced products.

• FDA pathways and claims: Only a small number of products that completed PMA or VLA processes can make healing claims; most CTP/skin substitutes cannot legally claim wound healing or infection reduction.

• Clinical documentation risk: Audit exposure increases when notes include non-permissible claims (often relayed by reps). Selecting lower-priced products and aligning documentation to the product’s regulatory category may reduce audit risk.

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. 

So there's another thing that I think is a dividend about the change in the way skin substitutes are being priced. And that has to do with some very worrisome behavior that we've seen with Medicare auditors denying payments inappropriately, as far as I can tell, denying payments based on the product that has been selected. 
 
I'm not an auditor. I'm not a lawyer. But I've seen the denials that people have sent me and said, “This is what I was denied for.” And Medicare auditors have denied payment, particularly for amniotic products, saying that they're not FDA approved. That is not a valid reason to deny a claim. But I suspect that they are singling out those products because in large part of their price and their medical auditors get to take a portion of the recruitment money. 
 
So I think they probably have looked specifically at very high-priced products and said, “Let's audit that,” because if in fact they're able to deny the claim, that's more money for them. I hope that I can't get sued for saying that, but it seems pretty obvious to me that that's the way it works. So I think once people switch to effective low-priced products, the medical auditors are going to have less incentive to just go after a claim in large part based on how much money is involved in the product that was chosen. I just think that is a reality that their behavior has been in part driven by that. 
 
But clinicians also haven't made it any easier because one thing I think clinicians haven't paid attention to is that when you select a product, and then you put in your note, “I picked this product because it does X,” there are really only about two products on the market that can make a claim about healing. The rest of the products out there that are classified as CTP/skin subs have not gone through the PMA process or VLA process to be able to make a specific claim to healing. 
 
And so clinicians, however, not understanding that are saying “Product X heals wounds and keeps people from being infected.” Well, that may be true, but the company can't claim that and the physician shouldn't say that in the note that “I'm using this because I know that it does X.” 
 
We have to be really cautious and we have to be sure we understand what kind of notes we can make about what kind of statement we can make about how a particular product works. And I think what's happened is that that practitioner is not understanding this. A rep has told them “Our product does X, Y, Z.” They dutifully put that in a note. It's not a claim that's legally able to be made. The auditors pick up on that and that has contributed to audits. 
 
So I think this is a great moment for clinicians to say, while I'm deciding which of these low-price products I'm going to pick, I'm going to make sure I understand what category they're in and what I'm allowed to say about how this product works to help a wound. That may be a complicated thought process, but there's no doubt that it has contributed to audits and that situation will improve with low-priced products.