The Prosthetics and Orthotics Podcast
The Prosthetics and Orthotics Podcast is a deep dive into what 3D printing and Additive Manufacturing mean for prosthetics and orthotics. We’re Brent and Joris both passionate about 3D printing and Additive Manufacturing. We’re on a journey together to explore the digitization of prostheses and orthoses together. Join us! Have a question, suggestion or guest for us? Reach out. Or have a listen to the podcast here. The Prosthetic and Orthotic field is experiencing a revolution where manufacturing is being digitized. 3D scanning, CAD software, machine learning, automation software, apps, the internet, new materials and Additive Manufacturing are all impactful in and of themselves. These developments are now, in concert, collectively reshaping orthotics and prosthetics right now. We want to be on the cutting edge of these developments and understand them as they happen. We’ve decided to do a podcast to learn, understand and explore the revolution in prosthetics and orthotics.
The Prosthetics and Orthotics Podcast
Additive Manufacturing Is Now Approved For Prosthetic Coding And Reimbursement
Two sentences from PDAC can potentially change the course of manufacturing history for O & P: additive manufacturing is now explicitly acceptable for coding prosthetic devices that meet existing HCPCS descriptions. We unpack what that clarity means for clinicians, patients, vendors, and payers, and how to adopt 3D printing.
• Why PDAC’s language ends the gray area for 3D‑printed prosthetics
• What PDAC and DME MAC do and how they shape coding
• How to match additive devices to existing L code descriptions
• Documentation discipline to avoid denials and audits
• FDA’s proactive stance and signals to industry
• Medicare vs Medicare Advantage realities for reimbursement
• When new codes help vs when they stall at zero pay
• Scaling care amid workforce shortages using digital workflows
• Using additive to improve fit, speed, and repeatability
• Practical steps to start: scanning, CAD, materials, records
Special thanks to Advanced 3D for sponsoring this episode.
Welcome to season 12 of the Prosthetics Orthodox Podcast. This is where we connect with experts in the field, patients who use these devices, physical therapists, and the vendors who help bring it all together. Our mission remains the same to share stories, tips, and insights that help improve patient outcomes. Tune in and join the conversation. We're glad you're here and hope it's the highlight of your day.
SPEAKER_01:Hello everyone. My name's Yoris Peels, and this is another edition of the Presthetics and Orthotics Podcast with Brent Wright. How are you doing, Brent?
SPEAKER_00:Hey Yoris. I'm doing well. I don't know how it is over your way.
SPEAKER_01:Uh-huh.
SPEAKER_00:But fall has officially started for us, and it's starting to get much cooler, and the leaves are very pretty, though.
SPEAKER_01:Okay.
SPEAKER_00:Okay. So uh when does it start getting colder out your way, or what what's the temperature like now?
SPEAKER_01:It's it's it's nice, actually. Well, I first off, I just got back from Singapore, so I'm a bit kind of confused generally. Uh and uh and then uh and here it's it was cold when I left, or cold for here when I left in Valencia in Spain. It's like good weather for about 330 or 40 days a year or something, and then it rains non-slop for the rest. Um and then uh um so it was cold-ish for us, and now it's warm again. So I'm wearing shorts and uh it's sunny. So uh yeah.
SPEAKER_00:When when does it start getting cold in Spain though?
SPEAKER_01:Um it kind of doesn't. Oh, really? So it's like No. Well, we are uh we are kind of like it doesn't really get cold, but but if you know people start wearing like long pants around like usually around you know November or something. Okay. But in December it can be like 2530 C uh or uh you know uh or even more. So it's a bit weird. The weather here's weird. I mean, last year it didn't rain for like 10 months. Oh wow. So it's it was a bit a bit strange, but but hey, usually it's very sunny and nice, easy. Yeah.
SPEAKER_00:Well, cool. Uh we're gonna try to get out there uh next year.
SPEAKER_01:Yeah, I totally do. You should come over. Love to host you around uh somewhere around here. Um okay, so we're doing this episode without a guest for a super special thing um that well we should have really uh attended to earlier, but I was traveling and it was difficult. And uh so there was a major step forward, a major administrative step forward uh for 3D printing and prosthetics orthotics. Uh that was a hurdle that uh was was a very important one, right? Right, Brett?
SPEAKER_00:Yeah, Joris. I mean, this is some really, really cool stuff. And we're gonna go through a lot of acronyms here. But the long and short of it is that the DME Mac, and we'll tell you what that is, and the PDAC posted on September 18th of 2025, the Additive Manufacturing Prosthetic Devices Correct Coding. And really, it's two sentences with one comma that potentially has the chance of changing the way prostheses are made here in the future. And what it says is additive manufacturing is an acceptable fabrication technique for items that are fabricated for the individual beneficiary. The correct coding for any item must meet the H HICPICS, uh HCPCS long description of the individual HICPIX code along with any other published coding guidelines. And so essentially what that means is additive manufacturing is now approved as a form of manufacturing for prostheses. What this does is puts a line in the sand, especially for those big companies like Equal, Hangar, uh, Embla, uh uh Formotion, um, Autobach, the big companies to say, hey, now we have the opportunity to really push into additive manufacturing for all prostheses. So I think it's a great option. And I think it's a great thing. So what is this PDAC thing, right? So so what is it? Yeah, so the PDAC is pricing, data analysis, and coding. And then they're they're also part of the durable medical equipment uh Medicare Administrative Contractors, DME, Max, and they uh uh together make decisions, kind of policy decisions around specif uh a bunch of things for medical, but this is specific for the prosthetic and orthotic industry. So what what they do is kind of set policy and they also try to look in the magic eight ball, crystal eight ball, and and try to get ahead of some things, which is which is actually kind of interesting for the government, right? To to try to get ahead of some things. And you know, one of the neat things that I think that they have done uh recently, and the government gets a bad rap of, but they have actually been very progressive in the way that they're looking at some of this prosthetic stuff. I I think that they really have the best interests of patients in in in in mind when it comes to that, which is which is a very positive thing. You know, that last year we got a bunch of codes, um, or this this actually this year. So click medical got the adjustable codes, which is what you uh you know love. We got some robotic stuff so um for to help people walk and then move people's arms. Um and then they just have released that they're going to be doing some some more codes specifically for people with partial hands. So, like we've had point designs on multiple times, and some of these multiple arm or hand manufacturers and that sort of thing are going to benefit from that. They also added pattern recognition, which is kind of a nod to uh machine learning, AI, and that sort of thing, uh, which we had uh Blair on from Coopt. So all positive steps.
SPEAKER_01:So this means that on a technology level, they're saying, hey, please uh this this is this is something that you're allowed to submit, but still uh I need to submit individual devices and things I do as well, additionally, right? But it's kind of like them waving a flag saying, yes, guys, this is like uh a way we want you to go, and we will uh there are more approvals forthcoming essentially, right? Or am I seeing this wrong?
SPEAKER_00:Yeah. So what they're saying is, and they never had been, it had been kind of a gray area um for additive manufacturing, which is why it's these big companies didn't really dive head into that. And and now you're gonna start seeing a lot of interest in it. Now, these codes, though, there's the we call them hick picks, but it still stands for healthcare common procedure coding system. And man, our government, and I don't know how it is uh over there, but they love acronyms, you know, the and the longer the better. Um, but essentially what that is, is is there are specific codes, number codes. So for instance, uh for a prosthesis, there's a L code called L5301, which is a below-the-knee molded socket, satch foot, endoskeletal system. So that's kind of like the base code. And then you can add codes to to that to describe the type of prosthesis that you are creating. And so what they're saying is that when you are using this code, uh additive manufacturing uh definitely covers uh when you use this types of uh this type of manufacturing, additive manufacturing is covered um when you're using these codes. Now, the reason why I say it was a gray area is that there is um the the idea of these devices still met many of the characteristics of these codes. It just wasn't fully defined um by the government. And so there were there were a lot of I would say more independent companies that that and that's the reason why they dove uh you know head in, head first into this, is because they believed that it actually did cover um additive manufacturing was part of the correct coding uh way to do things and the the uh manufacturing of orthotic devices. So I think that's that's really the big win. Last year they said that orthotic devices, and and what they were probably meaning was foot orthoses, so 3D printed foot orthoses were covered. But I think that there was a general understanding that if if if the 3D printing was an acceptable form of manufacturing for these orthoses, it kind of there's precedent to move forward into the additive manufacturing.
SPEAKER_01:Yeah, I I've I for one have been really amazed, like just generally uh authorities like the FDA, for example, on the additive manufacturing more generally, has been super proactive. Uh and and and of informing itself, uh sending stoppers to to meetings, to interact with people, trying to get really early kind of an idea in uh of what they were gonna do and which way they were going to be kind of very, very clear. And of course they want to be like the legislative thing uh arena for for for this kind of innovation, right? Because if everybody goes, of course, in in the uh for approval in in the FDA rather than in Europe or somewhere else, uh, it's of course gonna be really good for for America. So I think I think they're doing a really great job of doing this. And and and if they're if they've been really hesitant, they've been really kind of very uh hesitant about the right things, right? Uh so I think that that that that's also kind of like you know, about for example, infinite customization, stuff like that. People are trying to get like a kind of like um uh on implants. They were trying to get like, oh no, this is the thinnest and the thickest it can go, and then ta-da, just approve everything. And they they did some serious pushback on that. I think that's really smart. So um, so I think I think they're being really, really great on this and on the uh on this topic. And then I think this is a yeah, it's a sign of people like really, really working with industry and and really trying to be very proactive. So I think that's really, really very positive. Okay, he said big companies are gonna take notice, people are gonna be looking at this more in depth as well, just to because the chance of getting reimbursed, the chance of inventing a 3D printing device and getting that reimbursed is much higher, right?
SPEAKER_00:Yeah, and I and I I think this is an interesting discussion because what what do we say most of the time when people talk about additive manufacturing? It's it's just a form of manufacturing. So if you if you take the additive out and you just say it's manufacturing, it just makes common sense that it is going to be approved. But a lot of these larger companies were concerned that it might not be.
SPEAKER_01:Okay, okay. So now it's like full CMHA. And how does this process work? I mean, there were there a bunch of people that did this. Who's responsible for for getting us this win? I think, because this is a big deal, I think.
SPEAKER_00:That's a that's a great question, Yoris. And I think what I want to let our listeners know is this doesn't just happen in a vacuum and it doesn't happen by mistake. There were a lot of people involved in this, but uh those people don't necessarily uh want to be recognized or like to be recognized. So if you really want to know who who did this work, uh do yourself a little bit of search or LinkedIn message around that date and time. But I can I can assure you that the people that were driving this don't necessarily want the credit. They just deeply care about the field or the industry of prosthetics and orthotics. But what I can tell you is that AOPA, uh, the American Orthodic and Prosthetics Association, and their coding person, uh Joe McTernan, really took the bull by the horns on this one. And you've got to remember that AOPA is our forward-facing industry uh representation in the government, so to speak. And they're the ones that have the relationships with the PDAC and the DME Mac. And so uh with Joe uh facilitating some of these discussions, it really burst a nice discussion of hey, additive manufacturing really is a lot of times, in many ways, a lateral move. Many of the same materials are used. Uh, but in fact, sometimes the outcomes are better. And so this is where things get really interesting, is because it is important for Medicare to know that we not only are pushing the field forward, but this is a great way to scale to the upcoming needs of the future populations of an aging population. So you have less people providing care for more people as it comes down the line. So very important. So the bottom line is is AOPA really spearheaded this whole discussion?
SPEAKER_01:Yeah, I I've I for one have been really amazed. Like just generally uh authorities like the FDA, for example, on the outer manufacturing more generally, has been super proactive uh and and and of informing itself, uh sending staffers to to meetings, to interact with people, trying to get really early kind of an idea in uh of what they were gonna do and which way they were going to be kind of very, very clear. And of course, they want to be like the legislative thing uh arena for for this kind of innovation, right? Because if everybody goes, of course, in in the uh for approval in in the FDA rather than in Europe or somewhere else, uh, it's of course gonna be really good for for America. So I think I think they're doing a really great job of doing this. And and and if they're if they've been really hesitant, they've been really kind of very uh hesitant about the right things, right? Uh so I think that that that that's also kind of like you know, about, for example, infinite customization, stuff like that. People are trying to get like a kind of like um uh on implants, they were trying to get like, oh no, this is the thinnest and the thickest it can go, and then ta-da, just to prove everything. And they they did some serious pushback on that. I think that's really smart. So um, so I think I think they're being really, really great on this and on uh uh on this topic. And then I think this is a yeah, it's a sign of people like really, really working with industry and and really trying to be very practice. I think that's really, really very positive.
SPEAKER_00:Yeah. And I and I think that it throws everything back in the clinicians, and I think that's a that's a really important part as well, is um with the clinicians, it's up to us to make sure that we are coding correctly and that the devices meet the description of each of the codes based on the published coding guidelines. And uh I think that's a super uh important thing, is that it uh the it's a pretty massive responsibility. And we always say uh build for what you build um code for what you bill and bill for what you code. And and and while that makes sense, is this is it's just like making any other prostheses, you want to make sure, and it's up to the clinician to make sure that everything fits in the box. So and when I say that, for instance, an FDM socket that does not have carbon fiber in it, well, then you don't use the carbon fiber code. But that that just kind of makes sense, right? Um, so those are the types of things that are interesting. There are there are codes like carbon fiber and acrylic that are used in a lot of traditional fabrication, which gives you a little bit of a bump for your L codes. And those are the types of things that you've got to figure out for yourself how are you going to fabricate, how are you going to use additive manufacturing, and you want to use additive manufacturing and the way that you fabricate be described in the way that you code and bill. And I don't know that there's a lot of gray area in that. And so I think that's uh in fact, I I know that there's not a lot of gray area. You have to be confident in in the way that you're coding, and you just code the right way. That's uh in fact, I I know that there's not a lot of gray area. You have to be confident in in the way that you're coding, and you just code the right way. It seems obvious though, doesn't it?
SPEAKER_01:Yeah, but I think if you're working on different things, I think uh but also like it's an expensive mistake to make, right? Because they don't reimburse you, you have to go back, do the paperwork again, all this stuff. Uh so so so you want this is something you totally totally want to get right, right?
SPEAKER_00:Yeah, well, I mean, essentially it's fraud, right? If you're if you're billing for something that you actually didn't provide, okay, um that's that's uh Okay, so that's worse. So that's not the right thing to do. Um so and I think that's the the other part is don't take advantage of of the the system. Like um, you know, I've I've heard some interesting stories about you know the additive manufacturing and how do you build time and that sort of thing. And I would just say if it's if it's in the gray, you you don't want to mess with that because you don't want to mess with messing it up for other people, and that's that's actually what happens sometimes. Like they will take a look at um uh usage codes and and that sort of thing. And if they find some trends, which with AI and that sort of thing now, it's very easy to find those trends. And you just don't want to be on the wrong side of that. And so you just do the right thing. And uh that's that's that's that's essentially the messaging that I would have uh for that.
SPEAKER_01:Okay. And then and and are there more hurdles like this? I mean, uh, does this automatically mean that insurers are gonna be like way more into approving 3D printed stuff, or is that gonna take a lot more convincing as well?
SPEAKER_00:So most insurance companies follow what they say Medicare guidelines, but they are I mean, that's kind of the easy way out. But a lot of times they do carve things out and it causes issues for other things. And like, for example, right now, the people that have Medicare, which is the government insurance for people, I think it's 65 and older, um, that that straight Medicare, it's it's a cut and dry thing that they have coverage. Sometimes those people will get what's called a Medicare advantage plan through a myriad of these companies, Blue Cross, Blue Shield, United Healthcare, that sort of thing. And they might get other things covered. So they don't uh so they pay extra, and the government essentially pays these insurance companies to take the risk that they normally would have. Um, but what happens is a lot of times these Medicare Advantage plans actually are worse than straight Medicare because they're a private company and they're trying to maximize their profit. So they are going to carve things out, they're gonna make it a hassle to get the paperwork right, they will deny things after they've uh approved it, they will go and audit and try to take money back when they don't really have a reason to. And so it's a little bit of a mess, I would say, here in the United States for those Medicare Advantage plans. But what these L codes and that sort of thing does is give precedent to make sure that other insurance companies do start falling um uh falling suit, following suit in uh covering some of these items. But it's not as cut and dry as what you would think.
SPEAKER_01:Okay, cool. And then and uh I like this because it's like uh this is a uh a real administrative step forward. It's a sign of maturity, it's a sign that uh especially if AOPA gets involved, it's a sign that it's not only like three people promoting this. You know, it's it's like it has like broad support. Otherwise, they wouldn't do this, otherwise they'd be trying to get something else approved. So I think this is also a good sign of the the the in the eyes of the industry and regulator stuff that the the maturity of additive is improving. It's much more considered as being much much more mature technology.
SPEAKER_00:Yeah. And I and I think the I think just like stepping back in the in the big side of things, the maturing side of things, is that manufacturing is changing. You know, we're we have less technicians coming into the the industry, and uh there's gotta be other ways to take care of these patients. And the the amount of patients that we're seeing is starting to uh mushroom. So we have less people taking care of a larger uh group of people, and so there's gotta be a way that we have to um scale and to make sure that we're keeping up with taking care of patients and and so I think that's the the important part to remember is that yes, it's maturing, but we're also getting uh uh increased number of patients, uh technology's increasing, um, and being able to leverage that to make sure that we continue to take care of patients is a big deal.
SPEAKER_01:Okay, that's super cool. Uh I think that's it's really, really encouraging uh kind of sign for it. Um does this also mean that we could now lobby for more stuff and we're on the rise and that there's there's people that will listen, or or is this kind of like a one-off, or is it kind of like a sign that we should do more stuff like this together as an industry?
SPEAKER_00:Well, I think I think there's two signs. One is yes, that they are listening, and I and I love that. And the second is they didn't make a new 3D printing code. They're just saying that additive manufacturing is an appropriate way to manufacture a prosthesis. And I think that there's a that's a pretty important distinction, is when they took a look at the data, they felt that the function of what what what was at least presented to them falls under a current uh L-coding um system that uh shows the actual function of the device. So they're not saying that 3D printing now makes a better prosthesis, they're just saying you can use 3D printing to make a prosthesis. So, but with all that being said, is now that we have the adjustability stuff coming down the pike, the extra partial hand stuff, you know, what if we were to use uh some sort of lattice latticing to create extra padding or or that sort of thing, are there new codes on the horizon? I think that's an interesting you know thing. But what you don't want to do is start splitting hairs of like, oh, I need a new code because this is. I mean, the reality is this code set is pretty broad when you start looking at it. And uh what you don't want to do is, and uh a lot of companies have done this, invest a lot of money in in thinking that you have something really amazing and then find out that it's just coded the same way as everything else. And I'll give you one example is there's there was a uh manufacturer that created a uh a gel liner, we'll call gel air quotes, that had like little holes in it, and they they said that it helped regulate temperature uh better, and they went after a new code for that. And when the code coding committee or the people saw it, they're like, Yes, we see that your liner has holes in it, but it's still a gel liner, and so you know, this massive investment that they had now it's coded the same as everybody else's, and there's nothing that really separates it. And I think that's the part that people have to be you know really careful with. The other part is um the PDAC will release a new L code and they look for what's called utilization. So people that use the code, but just because they release a new L code doesn't mean that there's reimbursement that comes along with it, and so that's kind of the the scary part, right? So, oh yeah, we a hundred percent. I thought that was a couple of things. You have a new technology, congratulations. Right now, your reimbursement is zero on that, and so that is the other issue that you run into is you have this thing, and they say, yes, we agree that's a different technology that doesn't exist, but we don't know how to price it, and we're just gonna look at how many people use it. Well, on if you're looking at on my side and I see zero next to your code, guess what? I'm not using it. Um, because I don't want to fight that battle of trying to get paid for that. And maybe, you know, I need to change my mind on that. But the the reality is, is if I'm gonna use your product, you're gonna ask me to pay for it, right? So uh, and then I'm gonna have to go fight to get the reimbursement for it. And if right now it's zero, uh and I get zero, then I'm actually upside down on the product. Um, so it's it's complex. That's that's all I'm saying is that it's it's more complex than just getting an L code.
SPEAKER_01:Okay, okay. Well, that's good to know as well. And then um uh yeah, I just think this is really great news. I thought this was like um uh a good step forward, and I'm I'm happy we discussed it. I'm happy this is like kind of like a thing that's that's that's ongoing. Um, and I'm happy that more people now have to notice. You kind of have to have to talk about this, right? You have to be like, oh, okay, now we have to look at it. Now we have to see if this is for us. So I think I think uh I think it'll mean you know, more out of or more 3D printing, you know, business-related decisions will be taken, more more people will make parts. So I think it's gonna be super good.
SPEAKER_00:Yeah, well, and I think what you just said is now we have to have the discussion. And this this could be a tipping point. Well, and it was going to be a tipping point with the bigger companies, um, because now they can uh go into the additive manufacturing of space and know that they're going to invest in it and then know that they're going to also reap the rewards. And that's a conversation that you have with the people that aren't 3D printing is like, hey, why are you doing it traditionally fabricated? There are now outcome measures that show that some of these products are actually better for your patients than a tree uh a traditionally fabricated one. Uh I I also think the discussion becomes uh how do you how do you then start? What is the runway to to get going? Because those people are quote unquote behind. So how do we get them uh ahead of the or back on you know, the road to using additive manufacturing to its uh greatest potential. And I think that's that's going to be uh the fun part. And I think the other part though is I don't think you just use additive manufacturing just to do additive manufacturing. I think you use additive manufacturing to make it better for your patients. And so my hope is that change of thinking is okay, so if I'm not going to do traditional fabrication, what are the value ads that I can get out of additive manufacturing, but still get reimbursed because I'm doing it the manufacturing this other way? And I think that's really important.
SPEAKER_01:Okay. I think that sounds like a really sensible approach forward. And uh yeah, I really hope people get their heads around this and and uh that we see a uh veritable explosion of uh more additive manufacturing uh uh activity in uh prosthetics and orthotics. Because I think yeah, for a lot of things, uh you know, you you sketch the big picture already, like less labor. We need to somehow magically make more stuff with less people, with fewer people. So uh there has to be some form of automated making technology, whether it be additive or CNC or something else, that has to be used more intensively. And there has to be more design ability, there has to be more um you know technical ability to make the correct things with the right properties as well. Um, so there is the kind of like this this this bigger trend. Uh, and now uh I guess uh we're we're inching towards that. So I think that's really, really great. So uh thanks uh for for explaining that and uh thank you for all the PDAC people who ever involved on the government side, also on the uh on the the lobby business side and stuff. I think that's absolutely wonderful what uh everybody did, and uh really, really a great job uh to to to take this leap forward for everyone.
SPEAKER_00:Well, this was a fun one. Uh yeah, and I'm super excited because that means that we get to take a next step forward, right? And this additive manufacturing journey that we've been on, actually the last three years. We've been talking about this, I can't believe it, for three years. And uh now it's kind of gone mainstream. And uh so I think that's a that's a really cool thing. So I'm I'm looking forward to how this conversation evolves.
SPEAKER_01:Cool, mom. All right. So uh uh thank you for uh listening to another episode of the Prosthetics and Orthodox Podcast. Have a great day.
