Diabetic insoles, shoes, and Medicare coverage

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I routinely prescribe shoes and insoles for my patients who qualify, but a lot of them complain about them not fitting right or not being comfortable. When I examine the insoles, they are typically trilaminer insoles, but some of them have only two layers with claims that they last up to a year so the pt only ended up with a single pair rather than the 3 pairs I’m used to telling them about. Have you heard about this?

I tried looking into pubmed for evidence behind the why we’re using plastazote, there’s some stuff about reduction in peak plantar pressure, but couldn’t find anything on shear or incidence of blister/ulceration. I thought Medicare covers things only if there is evidence behind it. What are your thoughts? Am I missing something here?

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I routinely prescribe shoes and insoles for my patients who qualify, but a lot of them complain about them not fitting right or not being comfortable. When I examine the insoles, they are typically trilaminer insoles, but some of them have only two layers with claims that they last up to a year so the pt only ended up with a single pair rather than the 3 pairs I’m used to telling them about. Have you heard about this?

I tried looking into pubmed for evidence behind the why we’re using plastazote, there’s some stuff about reduction in peak plantar pressure, but couldn’t find anything on shear or incidence of blister/ulceration. I thought Medicare covers things only if there is evidence behind it. What are your thoughts? Am I missing something here?
NOTE: I'm a pedorthist and part owner of an orthotic and prosthetic central fabrication company.

There's no possible way that a top layer of 20 durometer plastazote would last a year under the weight of a diabetic patient, probably wouldn't even hold up a few months. If there is a top layer of plastazote then that middle layer of poron usually helps extend its life. Personally I prefer a trilam with a p-cell (20-25 durometer) top layer because it holds up better and has a much much smoother texture than plastazote.

As far as research I haven't seen any. I think it's just generally understood that trilams are the best material. Though a very small amount of orthotic companies will use bilams (like your supplier) because the material is cheaper for them to buy, not for the benefit of the patient. The HCPCS description for a custom diabetic insert technically just says multiple density which could be defined as "more than one" and there's only specific description of the base layer, so that's the justification I've heard for being able to switch to the bilam. But since there's such a small profit margin on providing diabetic shoes and inserts, and some companies actually lose money doing so, perhaps more companies are following suit and switching to cheaper materials.

The only thing that doesn't make sense to me is providing only one pair. The first pair really has the lowest profit margin, but after that the patient has already been evaluated and the positive models have been made so none of those extra costly steps have to be taken in making the 2nd or 3rd pair. Literally just heat the foam and form it over the models, takes a few minutes. That's foregoing money on the part of the supplier. So from a business perspective I don't understand why they wouldn't have switched to a cheaper material (even though I don't agree with that material choice) and still supplied 3 pairs of them. Unless they're billing for 3 pairs and only supplying one pair or doing something else fishy, which would make sense from a money-making perspective but is obviously fraud.

Personally, I would tell the supplier that they need to give your patients trilam or just switch suppliers. Although I know that may be hard cause some cities probably only have one or two suppliers left doing diabetic shoes and inserts, since it's such a headache.

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Good post. Since a lot of DPM residents are doing less and less custom orthotics, etc I think your insight would be greatly appreciated on these forums. I honestly do no orthotics or brace/shoe fabrication since I’m a hospital employee.

I refer out to HANGER or a mom and pop orthotic/prosthetic company nearby. I just hope for the best when referring my patients out.

If you could provide pearls of information on what we, as practitioners, should be looking for in certain products that would most helpful to us when we are determining if the quality of the product our patients are getting is even good or not.

That would be a major contribution to the forum and it should be stickied.

Please consider doing that for us
Thanks. I'll consider making a thread for that once I've got a gap in my schedule. It's a very difficult topic to cover like that just because of the variability in materials and fabrication techniques. While I could look at an orthosis and pretty confidently judge it's quality based on the materials used, the contours of the device, the trimlines, the finish (how plastics and foams are sanded), how the topcovers and padding are worked in (including whether a dummy was used during fabrication to account for the added thickness of any topcover—many companies do not account for this in which case you lose some degree of the contour of the foot), and on and on, it's pretty difficult to put a lot of that into words. But I'll see what I can do. And anyway, I'm always around to give my input on more specific orthotic topics that anyone brings up.

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NOTE: I'm a pedorthist and part owner of an orthotic and prosthetic central fabrication company.

There's no possible way that a top layer of 20 durometer plastazote would last a year under the weight of a diabetic patient, probably wouldn't even hold up a few months. If there is a top layer of plastazote then that middle layer of poron usually helps extend its life. Personally I prefer a trilam with a p-cell (20-25 durometer) top layer because it holds up better and has a much much smoother texture than plastazote.

As far as research I haven't seen any. I think it's just generally understood that trilams are the best material. Though a very small amount of orthotic companies will use bilams (like your supplier) because the material is cheaper for them to buy, not for the benefit of the patient. The HCPCS description for a custom diabetic insert technically just says multiple density which could be defined as "more than one" and there's only specific description of the base layer, so that's the justification I've heard for being able to switch to the bilam. But since there's such a small profit margin on providing diabetic shoes and inserts, and some companies actually lose money doing so, perhaps more companies are following suit and switching to cheaper materials.

The only thing that doesn't make sense to me is providing only one pair. The first pair really has the lowest profit margin, but after that the patient has already been evaluated and the positive models have been made so none of those extra costly steps have to be taken in making the 2nd or 3rd pair. Literally just heat the foam and form it over the models, takes a few minutes. That's foregoing money on the part of the supplier. So from a business perspective I don't understand why they wouldn't have switched to a cheaper material (even though I don't agree with that material choice) and still supplied 3 pairs of them. Unless they're billing for 3 pairs and only supplying one pair or doing something else fishy, which would make sense from a money-making perspective but is obviously fraud.

Personally, I would tell the supplier that they need to give your patients trilam or just switch suppliers. Although I know that may be hard cause some cities probably only have one or two suppliers left doing diabetic shoes and inserts, since it's such a headache.

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Thank you for a very informative post. So it sounds like Medicare decided that multilayer insoles is better than single layer insoles, and as long as the product generally fits that description, they will cover it?

I found the original article describing the design of the spenco insole, and describing how closed-cell 1/8” neoprene insole are effective at reducing blistering in athletes because the individual cells of the rubber can have more movement to accomodate shear forces compared to closed cell rubber. They then used 4-way stretch nylon for the top cover so the foot can slide into the shoe easier. Would it make sense to use this as one of the layers of the insole for diabetes since there is a bit of clinical and scientific reason for benefit?

Has anyone heard of Noene? The viscoelastic “shock absorbing” insole featured on shark tank, is this thing any good?

Does Medicare cover carbon fiber or steel insole supplement to the insoles? It would make sense to have something to protect against puncture wounds for at-risk feet. Additionally, limiting dorsiflexion of the MTPJs will reduce peak pressures to the met heads, so it would make sense for people with met head preulcerative lesions to have some strategy to limit dorsiflexion to the forefoot.
 
Thank you for a very informative post. So it sounds like Medicare decided that multilayer insoles is better than single layer insoles, and as long as the product generally fits that description, they will cover it?

I found the original article describing the design of the spenco insole, and describing how closed-cell 1/8” neoprene insole are effective at reducing blistering in athletes because the individual cells of the rubber can have more movement to accomodate shear forces compared to closed cell rubber. They then used 4-way stretch nylon for the top cover so the foot can slide into the shoe easier. Would it make sense to use this as one of the layers of the insole for diabetes since there is a bit of clinical and scientific reason for benefit?

Has anyone heard of Noene? The viscoelastic “shock absorbing” insole featured on shark tank, is this thing any good?

Does Medicare cover carbon fiber or steel insole supplement to the insoles? It would make sense to have something to protect against puncture wounds for at-risk feet. Additionally, limiting dorsiflexion of the MTPJs will reduce peak pressures to the met heads, so it would make sense for people with met head preulcerative lesions to have some strategy to limit dorsiflexion to the forefoot.
Last I heard, Medicare will pay as long as the insert is comprised of more than 1 layer with the base layer being at least 3/16" thick and 35 durometer. They don't specify what should be used as a top layer or whether there should be 2, 3, or 1000 layers.

As far as using rubbers for diabetic inserts, I personally wouldn't. Rubbers (neoprene, Neone, etc) and memory foams (poron) both reduce peak pressures with the major difference being that rubbers will have a subsequent rebound pressure much higher than memory foams. So that's probably good in sports so that you don't lose energy by sinking into a memory foam with no rebound, but for diabetics I'd rather have a poron layer which upon compression will reduce those peak pressures but then pretty much retains the compressed shape to accommodate the foot better and not have that rebound pressure—since pressure is the enemy. You should also be able to find studies that say that poron/PPT/memory foam or whatever you wanna call it reduces peak pressures so that would be just as justified.

That puncture protection idea is interesting. Never heard anyone try that for that purpose but they might cover it as a "shoe modification" in place of an insert. What you could also do is just swap out a pair of inserts for bilateral rocker bottom modifications to the diabetic shoes. Adding a half inch or so of 55 durometer crepe to the sole of a shoe stiffens it pretty significantly and that combined with the added contour would reduce MTPJ dorsiflexion and forefoot pressure. Rocker bottoms would definitely be covered as substitutions for a pair of inserts. Though not sure if that would do much in terms of puncture protection.

They do cover carbon fiber plates to go with great toe fillers, not 100% sure about coverage if there's a lesser toe amputation or no amputation.
 
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Last I heard, Medicare will pay as long as the insert is comprised of more than 1 layer with the base layer being at least 3/16" thick and 35 durometer. They don't specify what should be used as a top layer or whether there should be 2, 3, or 1000 layers.

As far as using rubbers for diabetic inserts, I personally wouldn't. Rubbers (neoprene, Neone, etc) and memory foams (poron) both reduce peak pressures with the major difference being that rubbers will have a subsequent rebound pressure much higher than memory foams. So that's probably good in sports so that you don't lose energy by sinking into a memory foam with no rebound, but for diabetics I'd rather have a poron layer which upon compression will reduce those peak pressures but then pretty much retains the compressed shape to accommodate the foot better and not have that rebound pressure—since pressure is the enemy. You should also be able to find studies that say that poron/PPT/memory foam or whatever you wanna call it reduces peak pressures so that would be just as justified.

That puncture protection idea is interesting. Never heard anyone try that for that purpose but they might cover it as a "shoe modification" in place of an insert. What you could also do is just swap out a pair of inserts for bilateral rocker bottom modifications to the diabetic shoes. Adding a half inch or so of 55 durometer crepe to the sole of a shoe stiffens it pretty significantly and that combined with the added contour would reduce MTPJ dorsiflexion and forefoot pressure. Rocker bottoms would definitely be covered as substitutions for a pair of inserts. Though not sure if that would do much in terms of puncture protection.

They do cover carbon fiber plates to go with great toe fillers, not 100% sure about coverage if there's a lesser toe amputation or no amputation.

Didn’t know that about the 35 durometer base requirement, that is interesting. Also good to know that you could take away one of the three insoles to make a rocker modification that’s covered. I will definitely take advantage of this benefit.

So, friction force is what causes calluses, blisters, and ulcers. Friction force is a function of pressure, and certainly more pressure leads to more friction force, but pressure without friction is much less damaging than pressure with friction, so really friction is the enemy, but pressure contributes to it. Materials that reduce pressure is great, but which allows greatest amount of lateral movement (Or has the lowest coefficient of friction) among EVA, PPT, poron, plastazote, vs spenco? For this reason, inelastic materials don’t seem to make sense, there should be some amount of elasticity in the AP/mediolateral direction. I’ve seen plenty of ulcers occur while wearing custom plastazote insoles and DM shoes, so I wonder if there is a better way.
 
Didn’t know that about the 35 durometer base requirement, that is interesting. Also good to know that you could take away one of the three insoles to make a rocker modification that’s covered. I will definitely take advantage of this benefit.

So, friction force is what causes calluses, blisters, and ulcers. Friction force is a function of pressure, and certainly more pressure leads to more friction force, but pressure without friction is much less damaging than pressure with friction, so really friction is the enemy, but pressure contributes to it. Materials that reduce pressure is great, but which allows greatest amount of lateral movement (Or has the lowest coefficient of friction) among EVA, PPT, poron, plastazote, vs spenco? For this reason, inelastic materials don’t seem to make sense, there should be some amount of elasticity in the AP/mediolateral direction. I’ve seen plenty of ulcers occur while wearing custom plastazote insoles and DM shoes, so I wonder if there is a better way.

PPT/poron (same thing) essentially crumbles under friction so it can't be used directly against the sock/skin, there always needs to be another layer on top of the PPT/poron. From memory I would think that EVA and the fabric layer that comes bonded to Spenco both have lower coefficients of friction than plastazote. So still I would personally vote for a trilam with a PPT/poron middle layer for pressure reduction and an EVA top layer for better durability and less friction than plastazote.

If you've seen "plenty" of ulcers occur while using diabetic shoes and inserts then I'd question the quality of the inserts and the shoes. Perhaps the inserts should be custom beyond just the contours of the plantar foot. Perhaps better built in reliefs or areas specially padded (extra poron beneath the top layer in certain areas for instance, but with the same contour to the top surface of the insert) to better match the high risk areas of a patient's foot rather than just simply the same thickness and densities of materials along the entire foot. Even if soft accommodative materials are used, if the entire insert is the exact same density maybe the high risk areas still aren't getting enough pressure relief relative to other areas—since the only way to reduce pressure in one area is to redistribute it elsewhere and that may not be happening if there's no relief in the top surface or no change in densities between different areas. Simply making an insert shaped to the foot may not be good enough for some patients. Also perhaps in some of those situations custom shoes could maybe be utilized. Or maybe rocker bottoms on regular diabetic shoes like we were talking about. I'm just spitballing here.
 
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Also I would add that the major limitation of Spenco and other neoprene rubbers is that they are not thermoplastic. So its virtually impossible to incorporate neoprene into an insert without a rigid base such as plastic, cork, etc. Bonded to softer materials neoprene will just try to unfold back into its flat sheet form and the insert would just lose its form. You might never find an orthotic company that would try to work neoprene into an accommodative soft insert or if you did I doubt you would be happy with the product. That's another reason why neoprene is better suited for functional orthoses rather than accommodative diabetic orthoses.
 
PPT/poron (same thing) essentially crumbles under friction so it can't be used directly against the sock/skin, there always needs to be another layer on top of the PPT/poron. From memory I would think that EVA and the fabric layer that comes bonded to Spenco both have lower coefficients of friction than plastazote. So still I would personally vote for a trilam with a PPT/poron middle layer for pressure reduction and an EVA top layer for better durability and less friction than plastazote.

If you've seen "plenty" of ulcers occur while using diabetic shoes and inserts then I'd question the quality of the inserts and the shoes. Perhaps the inserts should be custom beyond just the contours of the plantar foot. Perhaps better built in reliefs or areas specially padded (extra poron beneath the top layer in certain areas for instance, but with the same contour to the top surface of the insert) to better match the high risk areas of a patient's foot rather than just simply the same thickness and densities of materials along the entire foot. Even if soft accommodative materials are used, if the entire insert is the exact same density maybe the high risk areas still aren't getting enough pressure relief relative to other areas—since the only way to reduce pressure in one area is to redistribute it elsewhere and that may not be happening if there's no relief in the top surface or no change in densities between different areas. Simply making an insert shaped to the foot may not be good enough for some patients. Also perhaps in some of those situations custom shoes could maybe be utilized. Or maybe rocker bottoms on regular diabetic shoes like we were talking about. I'm just spitballing here.

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A lot of good ideas here. It seems complicated and requires a lot of skill and effort to make different densities in different areas, and maybe I need a different supplier. I understood better what you’re saying after reviewing this A few facts about shock absorbing materials for orthoses. / LBG Medical

I didn’t think I was gonna do this, but you seemed interested and open to ideas, so here’s some more food for thought: The study of friction in feet (biotribology) is super complicated, because different fabric types, knit pattern, density of the fabric/material, and moisture affects the coefficient of friction. In feet, we also take into account bony prominences and how there is peak plantar pressures during push off, which could also be thought of as max friction force during push off. Such as bedridden patients who have sacral ulcers are recommended to lay flat as opposed to having the head of the bed elevated to reduce sacral pressure and shear, the same concept can be applied to the plantar metatarsal head, and efforts to limit dorsiflexion should theoretically reduce peak pressure and shear.

Studies on coefficient of friction (COF) of different insole materials and fabrics are confusing because there’s a lot of factors to take into account mentioned above, here’s some of the graphs I’ve found:
1CBA10EC-E8CD-4E60-8DB8-5B33C20110F0.jpeg


The palm of the hand has a dynamic COF of 0.21

24581957-C725-4D24-BECA-E870A1646149.jpeg

However, this other study on I believe static COF of the palm was double that found above at 0.62. Static COF is normally higher than dynamic COF, but we this value may vary between people with different occupations, like the palm of a weightlifter probably has a higher dynamic and static COF than many.

FC0A4108-B243-40B6-BB51-7F898CD995A3.jpeg


This is a biased study published off the website of a company called Tamarack, but its interesting because it shows how moisture increases the COF of most materials (I don’t believe the low COF of the PTFE film, it should be higher such as in the graph below). Notice how the COF of nylon vs skin on the previous graph is 0.37 whereas the COF of this nylon vs sock is around 0.5-0.6.

7C1743FE-5065-474E-A6C7-97DE6DE85F5E.jpeg


Last image, the PTFE film is closer to 0.2 which seems more realistic. It would make sense that plastazote and ppt/poron would not increase by much with moisture because they are closed-cellular structures (correct me if I’m wrong on this one) while Spenco increased by a lot because really the test is measuring the COF of the stretchy nylon fabric top cover. In case you were wondering, the study looked at a few athletes after intense activity and measured sock moisture content to be around 20-30%.

I can’t really draw any conclusions from these graphs other than the fact that there are so many combinations of surfaces and factors that could be tested. And then, there’s clinical tests, which mostly were done before the year 2000 and they were all on athletes, none were on diabetic feet and incidence of ulceration (at least I couldn’t find any, hoping maybe I just missed something). It doesn’t make sense to me why Medicare would pay so much for something so poorly studied.
 
Also I would add that the major limitation of Spenco and other neoprene rubbers is that they are not thermoplastic. So its virtually impossible to incorporate neoprene into an insert without a rigid base such as plastic, cork, etc. Bonded to softer materials neoprene will just try to unfold back into its flat sheet form and the insert would just lose its form. You might never find an orthotic company that would try to work neoprene into an accommodative soft insert or if you did I doubt you would be happy with the product. That's another reason why neoprene is better suited for functional orthoses rather than accommodative diabetic orthoses.

I haven’t thought about it like that, makes sense! I have doubts about the benefit of needing accommodation for diabetic feet, because most ulcers occur in the forefoot, infact the most common location for ulceration is the 1st met head and the hallux, so it would make sense to construct an orthotic that focuses on shear reduction at that area.

AB643CA0-F243-43DC-812A-002A3E5267FE.jpeg

(Study from 2006 Perell et al in a VA population w active ulcers)
 
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A lot of good ideas here. It seems complicated and requires a lot of skill and effort to make different densities in different areas, and maybe I need a different supplier. I understood better what you’re saying after reviewing this A few facts about shock absorbing materials for orthoses. / LBG Medical

I didn’t think I was gonna do this, but you seemed interested and open to ideas, so here’s some more food for thought: The study of friction in feet (biotribology) is super complicated, because different fabric types, knit pattern, density of the fabric/material, and moisture affects the coefficient of friction. In feet, we also take into account bony prominences and how there is peak plantar pressures during push off, which could also be thought of as max friction force during push off. Such as bedridden patients who have sacral ulcers are recommended to lay flat as opposed to having the head of the bed elevated to reduce sacral pressure and shear, the same concept can be applied to the plantar metatarsal head, and efforts to limit dorsiflexion should theoretically reduce peak pressure and shear.

Studies on coefficient of friction (COF) of different insole materials and fabrics are confusing because there’s a lot of factors to take into account mentioned above, here’s some of the graphs I’ve found:
View attachment 225874

The palm of the hand has a dynamic COF of 0.21

View attachment 225876
However, this other study on I believe static COF of the palm was double that found above at 0.62. Static COF is normally higher than dynamic COF, but we this value may vary between people with different occupations, like the palm of a weightlifter probably has a higher dynamic and static COF than many.

View attachment 225875

This is a biased study published off the website of a company called Tamarack, but its interesting because it shows how moisture increases the COF of most materials (I don’t believe the low COF of the PTFE film, it should be higher such as in the graph below). Notice how the COF of nylon vs skin on the previous graph is 0.37 whereas the COF of this nylon vs sock is around 0.5-0.6.

View attachment 225877

Last image, the PTFE film is closer to 0.2 which seems more realistic. It would make sense that plastazote and ppt/poron would not increase by much with moisture because they are closed-cellular structures (correct me if I’m wrong on this one) while Spenco increased by a lot because really the test is measuring the COF of the stretchy nylon fabric top cover. In case you were wondering, the study looked at a few athletes after intense activity and measured sock moisture content to be around 20-30%.

I can’t really draw any conclusions from these graphs other than the fact that there are so many combinations of surfaces and factors that could be tested. And then, there’s clinical tests, which mostly were done before the year 2000 and they were all on athletes, none were on diabetic feet and incidence of ulceration (at least I couldn’t find any, hoping maybe I just missed something). It doesn’t make sense to me why Medicare would pay so much for something so poorly studied.
PPT/poron is an open cell material, so it absorbs moisture pretty readily. That probably accounts for the large jump from dry to wet COF in your first chart. Also, its a thermoset so you can't really heat mold it like you could an EVA or plastazote. That's another reason its usually sandwiched in between two thermoplastic materials. It seems a little more flexible than neoprene though which is probably why you can't really sandwich neoprene the same way with as much ease.

I wonder exactly which materials these companies used for the neoprene/Spenco and for the PPT/poron. Because I'm sure you can buy the neoprene with or without the bonded fabric cover and you can also buy PPT/poron with both sides abrasive (for gluing), both sides having a smooth finish, or one abrasive side and one finished side. Also, like I said before, whatever the coefficient of friction of poron is its not durable under friction force and it crumbles pretty quickly if you try to use it as a top layer.

And while I would still contend that you can accomplish a lot with just pressure reduction, we have also used ShearBan (PTFE) in some cases on the forefoot of orthoses. My only problems with that is it doesn't flex quite as well as most other materials so it ends up wrinkling along the edges over time and also it may actually be too slippery. Like I would almost worry then about the foot sliding too far mediolaterally or anteriorly during gait when its on PTFE and that could cause problems of its own. PTFE could also be put just under the 1st MTPJ but like I said it doesn't flex super well and it would most likely form permanent wrinkles relatively quickly which could then cause their own problems.

Have you ever had a patient try something like the TheraSock that SmartKnit sells? Its basically a sock with two fabric layers to reduce friction. Or perhaps just have the patient wear two socks. I'd imagine using that with an EVA or plastazote top cover would leave you somewhere between (1) the friction you would get with EVA or plastazote and one sock and (2) the friction you would get with PTFE and one sock. So that may hit a sort of Goldilocks zone of friction.
 
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So it sounds like ppt/poron is the material of choice for shock absorption, is it >35 durometer? I wonder if it could be used as a base and be thicker. If I wanted to test a flat neoprene mid-layer in the forefoot, could that be accomplished and be covered by insurance? Does your facility do it or would Hangar do it?

I’ve gotten some samples from tamarack and tried the shearban, it’s an interesting concept. It may have a role in prevention of ulcer recurrence. Their glidewear socks are pretty cool too. I tried their glidewear patches, very hard to apply to the outside of the sock, and with the way the seams are, I’m hesitant to recommend it being applied directly to skin under socks. They advertise it as potentially treating acute ulcers, can’t imagine it being practical if it gets bloody and they’d have to keep washing it. Haven’t tried therasocks. I tell my patients to wear two layers, with the inner layer ideally being of synthetic thin material.
 
So it sounds like ppt/poron is the material of choice for shock absorption, is it >35 durometer? I wonder if it could be used as a base and be thicker. If I wanted to test a flat neoprene mid-layer in the forefoot, could that be accomplished and be covered by insurance? Does your facility do it or would Hangar do it?

I’ve gotten some samples from tamarack and tried the shearban, it’s an interesting concept. It may have a role in prevention of ulcer recurrence. Their glidewear socks are pretty cool too. I tried their glidewear patches, very hard to apply to the outside of the sock, and with the way the seams are, I’m hesitant to recommend it being applied directly to skin under socks. They advertise it as potentially treating acute ulcers, can’t imagine it being practical if it gets bloody and they’d have to keep washing it. Haven’t tried therasocks. I tell my patients to wear two layers, with the inner layer ideally being of synthetic thin material.

Unfortunately PPT is not over 35 durometer and not thermoformable so it would be difficult to make a base layer from it. You could just lay a flat piece of it under an insert but you'd lose a lot of the effect due to the overlying 35 durometer layer of the base of the insert.

You can buy prelaminated bilam and trilam materials which is what most companies do to save time and ultimately money. Orthotic companies could also laminate their own materials together which would allow for things like incorporating neoprene into the forefoot only (easy peasy since the forefoot part is essentially flat and uncontoured anyway) or thicker layers of PPT than what comes in the premade sheets or have variable cushioning in different areas like I talked about earlier (maybe extra PPT or neoprene under 1st MTPJ only). That just all starts cutting into the minimal profit that's there and becomes unfeasible pretty quickly, even though it would probably benefit a lot of patients. Though it is technically possible for pretty much any lab to do any of that for you. Also like I briefly mentioned above they do sell a variety of trilams so you could switch to a trilam which is pretty much standard of care but with a 1/8" middle layer of PPT/poron rather than the standard 1/16" layer that most companies use. Or you can get it with a slow recovery poron (even less rebound pressure) rather than the standard poron.

As far as being covered the HCPCS code only specifies the base layer material should be 3/16" and at least 35 durometer so whatever other materials are anywhere else doesn't matter, it would be covered. You could use a 3/16" 35 durometer base with a 1/4" poron middle layer and only 1/16" of EVA or plastazote top layer of you wanted to. Or a 3/16" 35 durometer base layer with a neoprene forefoot middle layer and a poron midfoot/rearfoot middle layer and an EVA or plastazote top layer. Whatever you can imagine. The only limitation would be how much Medicare reimburses per insert and how much it costs to make each of these deluxe inserts.

If you were interested, while I'm home over Winter break I could scrabble together some sample squares of different layers of materials laminated together (whatever you want) and ship them to you.
 
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Unfortunately PPT is not over 35 durometer and not thermoformable so it would be difficult to make a base layer from it. You could just lay a flat piece of it under an insert but you'd lose a lot of the effect due to the overlying 35 durometer layer of the base of the insert.

You can buy prelaminated bilam and trilam materials which is what most companies do to save time and ultimately money. Orthotic companies could also laminate their own materials together which would allow for things like incorporating neoprene into the forefoot only (easy peasy since the forefoot part is essentially flat and uncontoured anyway) or thicker layers of PPT than what comes in the premade sheets or have variable cushioning in different areas like I talked about earlier (maybe extra PPT or neoprene under 1st MTPJ only). That just all starts cutting into the minimal profit that's there and becomes unfeasible pretty quickly, even though it would probably benefit a lot of patients. Though it is technically possible for pretty much any lab to do any of that for you. Also like I briefly mentioned above they do sell a variety of trilams so you could switch to a trilam which is pretty much standard of care but with a 1/8" middle layer of PPT/poron rather than the standard 1/16" layer that most companies use. Or you can get it with a slow recovery poron (even less rebound pressure) rather than the standard poron.

As far as being covered the HCPCS code only specifies the base layer material should be 3/16" and at least 35 durometer so whatever other materials are anywhere else doesn't matter, it would be covered. You could use a 3/16" 35 durometer base with a 1/4" poron middle layer and only 1/16" of EVA or plastazote top layer of you wanted to. Or a 3/16" 35 durometer base layer with a neoprene forefoot middle layer and a poron midfoot/rearfoot middle layer and an EVA or plastazote top layer. Whatever you can imagine. The only limitation would be how much Medicare reimburses per insert and how much it costs to make each of these deluxe inserts.

If you were interested, while I'm home over Winter break I could scrabble together some sample squares of different layers of materials laminated together (whatever you want) and ship them to you.

Thanks bob, I’ll send you a PM
 
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