Focus on Compliance: Observations on the Impact of Skin Substitute Fraud, Waste, and Abuse

In Part 2 of this interview series, Zwelithini Tunyiswa, BS, and Ryan Dirks, PA-C, of Open Wound Research confront the emotional and operational fallout of intensified fraud, waste, and abuse scrutiny in wound care—particularly as it relates to CAMPs. They explore how an aggressive audit environment has blurred the line between intentional misconduct and good-faith clinical practice, and what this moment means for providers trying to remain compliant while staying focused on patient-centered care. 

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• Heightened enforcement has created collateral damage for well-intentioned providers. While extreme cases of abuse warrant accountability, the current “dragnet” approach has pulled compliant clinicians into prolonged audits and appeals, draining resources and, in some cases, forcing the closure of practices that were trying to do the right thing—often in regions with few alternatives for vulnerable patients. 
• Audits do not equal bad care, but the lack of clear guidance has raised the stakes. Many providers are being judged retroactively for documentation and decision-making that occurred before formal CAMPs guidance existed. Tunisiwa and Dirks emphasize that audits, repayments, and appeals are now a reality of practicing in US healthcare—and do not inherently reflect poor clinical intent or unethical behavior. 
• Sustainable wound care requires clear “fences,” conservative decision-making, and patient-first focus. In the absence of finalized policies, proactive compliance strategies—such as internal clinical practice guidelines, defined treatment boundaries, and ongoing communication with MACs—are essential. Ultimately, the speakers stress that clinicians must remain grounded in their mission: providing dignity, comfort, and appropriate care to patients, regardless of whether wound closure is achievable. 

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. 

You talk about compliance early on, and so I think we would be remiss if we did not talk a little bit about fraud, waste, and abuse in some of these cases we've seen, especially out of Arizona – I'd love to get your thoughts. I have a couple of thoughts as well of sort of the schematic of how these things happened. 

I have so many mixed thoughts. And you mentioned voices in our industry. And I have, this is the first time I've ever outside of a work friend circle (that) I've ever really talked or given my opinion. I'm not a blogger. I'm not a LinkedIn person. I have a close-knit group of people within my sphere of influence, including our providers and that's where I've pretty much just kept and stayed. So I hesitate to say a lot of opinions other than it's a lot of mixed emotions. It makes me sad. It makes me angry. It in some ways, kind of makes me glad because we're going to get hopefully a lot of people out of this industry that should have never been in in the first place. But I don't know as well. I just, I've seen it all and I'm watching it and I'm trying not to be distracted from it. You know, at the end of the day, we  go out and take care of people's moms and dads, grandmas and grandpas just as good as we always have. and try not to get caught up in the wave of negativity of it.  

I'm not a negative person, but you become like the people you're around. And so I have to be careful just where I spend my time and my thought. But at the end of the day, as soon as I walk into that patient's room, none of this matters. You know, what matters is do I have the tools I need to take care of my patients and can I communicate well with them? Can I make sure that what I'm doing for them is going to give them the best possible success, whatever success looks like for the relationship I have with my patient?  

And some of our patients, it's not that the wound is going to close. And they're okay with that and I'm okay with that. But it took me a long time in my career as a wound specialist and I work with our providers today on this is it's not a failure if you can't get the wound to close it's a failure, if you decide that I only want to treat patients that I can get the wound to close and everybody else I'm going to sign off on and just give up on. I mean, that's not what good providers do. Good providers are there to talk with your patients and help them, comfort them, provide pain relief, provide odor control, dignity and quality.   

When it comes to the fraud, waste, and abuse and compliance, I have so many mixed emotions but, we’ve got to get through this. We need to get to a point where people are not so focused on the negativity of what we do because what we do is great, it's beautiful. It's needed. To be in the game you have to know how to take care of your patients, you have to know how to follow the rules. You know, that's a necessity as well.  

So I don't know, do you want me to speak specifically on anything? No, I don't want to belabor the point around this because I know it's a very sensitive subject for many people and we need to be extremely careful about how we talk about it because, You know, there's a lot of emotions, a lot of hurt. Suffice it to say, from my side, I would say that, you know, there are extreme cases like Arizona. But what I'm observing as well, and I know this from my time managing groups, is that there's this dragnet that started, right? And then people get pushed into this dragnet, and good people are actually trying to do the right thing, get treated the same as people who are trying not to do the right thing. And it takes a lot of energy and resources to fight some of these administrative things. 

 And I am saddened, because I talk to a lot of people like you do, and there are people that I know are committed to doing the right thing. We're trying to do the right thing. And they have some guy who barely knows statistics, pulls them out, and then starts raking them over the coals, resulting in some cases to the demolition of practices. 

And I think that's sad because at the end of the day,when that person goes out of business in an area of the country where there are not many alternatives and they were trying to do the right thing and the system is set up for them to basically lose what have we truly accomplished you know and what about those patients with holes in their bodies - who's going to come to help them? That's what saddens me about this whole thing. 

 And just as another side, you know, a couple of weeks back, there was a mailer to a bunch of people who I consider acquaintances and friends that I know are trying to do the right thing. And there are companies that are benefiting from this and trying to scare people and make money by clawing back from good providers.So, like you, it's upsetting. It's confusing. Some of it is justified in the extreme cases, but it is just upsetting because at the end of the day, when the smoke clears, are we going to be better or worse off? And I want our field to really do the great work that it ought to do and has done for a very long time.  

I think I want to add a little bit to that because I think I went to a conference recently and they had a very reputable speaker that talked specifically about like the auditing environment going forward and I mean I wouldn't recommend doing this but if you turn on the news you will see a myriad of things going on in the world and in our country where you're scratching your head and you're going, what the heck? It's no different in wound care and where we are. We're all scratching our heads going, what the heck? So it could  be a big distraction and cause us to have a lot of fear and cause us to do something like leave the industry. There's a ton of confusion out there in the noise, in the media and everything that's happening. And when I was at this conference, this person made a comment that within the last maybe two months, there's been upwards of 4,000 U PIC audits that have been sent out regarding CAMPs. And we all know, government efficiency and everything that's been happening. And so it's no surprise.  We all know it's coming. But as I've talked to more and more people in the industry, what I think that people have to understand and what I'm trying to convey to the people around me is that just because you got an audit or just because you had to pay money back because maybe you didn't know what your documentation should have been three years ago or whatever, it doesn't mean that you're a bad clinician or that you had bad intentions or anything like that. I mean, this is the price that we pay to be in our American healthcare system. Now it was before and it is going to be going forward. It's not an excuse for the people that have abused the health care system. And, you know, I think it's interesting. We have 4,000 audits going out, but, you know, what about 100, you know, people that are going to jail or, should be considered for criminal investigation?  I'd like to hear more about that, personally. But now it's kind of like we're all in this, and we're all under scrutiny. And that's fine. We should be.  

So, I think if we look at in the, particularly the CAMPs issue in the post-acute setting, is that they haven't been available. You know, those started to become reimbursable in 2021 or something like that, 2021 or 2022. So there was no guidance. We had to get on the phone and email our MAC all the time and specifically say, hey, what do we need to document and when do we need to use these? When do we not need to use these? We've had on the compliance side to do a lot of our own due diligence and we had to create clinical practice guidelines to be able to tell our clinicians and put up some fences. Fences are good. We put fences around things. Everybody's happy, right? Like, I got a fence and my neighbor loves it because it keeps my dog out of his yard and, you know, all these things. 

Fences aren't bad. It's just when we don't know where the lines are and where the fences are. So I think we're going to have a lot of people that may be getting discouraged from their audits and discouraged from things that are happening. And in some ways, I haven't seen it personally, but I've been hearing about things that are just flat out unjust. It's like, how are we holding people in an audit environment to policies that have never been finalized, or, you know, I've heard of people taking their audit appeals to the ALJ level, having a favorable ruling, and then having CMS come back and say, yeah, we don't agree with that. So it has to go to the federal appeals court or whatever. It's like, for crying out loud, at the end of the day, we're just trying to take care of somebody's grandma that's in bed that needs some extra help. And so nobody's got time for that. And let's be honest, nobody's got the money to do that. So there are a lot of discouraging things out there. And so, when I get frustrated or discouraged, I just go out and I just start seeing patients with our providers and talk to them, smile, listen, and that kind of helps reverse things.  

But we got here for a reason. It's going to take some time to fix it. But back to your question about compliance, going to take a focus on just making sure we're doing the right thing at the right time for the right reasons and being as conservative as possible as we can with our treatment choices. 

Zweli Tunyiswa is Chief Executive Officer and Co-Founder of Open Wound Research. 

Ryan Dirks is the Chief Clinical Officer and Co-Founder of Open Wound Research.