Hello, and welcome to this module of the ATPPS and AAOE DME course. My name is BJ Mack, I'm an athletic trainer, I'm the Senior Director of Inovus' Healthcare Solutions Divisions, and today we're going to talk about the fun topic of Medicare updates and changes for the DME world. So this will be a presentation focused around what we're hearing, what we're seeing, as far as regulations and rules that are coming. I'd like to start off with a disclaimer here, just to make sure that we are all on the same page. This information has been taken either from the CGS or Neridian sites, or information that they have put out, so the disclaimer here is that we're as current as we can be as of this date of recording, and that if there's any changes afterwards, that would supersede anything you hear that I'm relaying today. Learning objectives, what we hope that you guys get out of this. First one, to identify recent changes in Medicare requirements for durable medical equipment. Second one, examine strategies for successfully meeting documentation requirements. Third, examine ways to overcome errors in DME documentation through effective appeal letters. Fourth, assess anticipated changes for DME in 2025 and beyond. And finally, learn why DME can be challenging in our world today. I'd like to start with just a general overview. For some of you, this may be brand new knowledge. For a lot of you, this may be very simple, but I think it's helpful to just set the table for what are these devices that we are talking about. So you will see the phrase DME, durable medical equipment, or DME POS, DEMIPOS, durable medical equipment, prosthetic, orthotic, surgical supplies. But let's talk about what an orthosis is. Can be an orthotic device, is the first one there. Prefabricated or semi-rigid devices used for the purpose of supporting weak or deformed body member or restricting and eliminating motion in diseased or injured part of the body. Custom fabricated, these are going to be individually made for a specific beneficiary or patient. And then starting with basic material, you're creating something from nothing. And it involves a whole lot more than just trimming, bending, or making other modifications to substantially prefabricated item. And a lot of what we're going to be talking about today and a lot of what you guys deal with is that last point there, prefabricated orthosis. Both off-the-shelf quote and custom fit items are considered prefabricated for Medicare coding purposes. And they're manufactured in a quantity without a specific patient or beneficiary in mind. So just to kind of help set the table for some of these terms that we'll be talking about. So let's dive into what custom fabricated is. Again, it's individually made for the specific beneficiary. You're making this or fabricating this based on clinically derived castings, tracings, measurements, other images of the body part. And you have basic materials including but not limited to plastic, metal, leather, cloth in the form of uncut or unshaved sheets, bars, or other basic forms. And so the person doing this work is actually doing very substantial things like vacuum forming, cutting, bending, molding, sewing, drilling, finishing before putting it on the patient. And you do need a positive model of the beneficiary. Let's dive into minimal self-adjustment versus more than minimal modification. So really what these two columns indicate is what is off the shelf, what is custom fitted. So on the left, the beneficiary themselves, the caregiver or supplier, they can perform the adjustment. It does not require a certified orthotist or individual specialized training. An example of this would be just the adjustments of the straps or the closure, a little bit of bending or trimming for final fit or comfort. That's a lot different than on the right. For custom fitted, you're making changes to achieve individualized fit during the final fitting. This does require the skills of a certified orthotist or an individual with specialized training. And what you're doing is trimming, bending, molding, with or without heat, or modifying any modification that results in alterations beyond just the minimal self-adjustment. So if you are going to document custom fit need for a patient versus just minimal off-the-shelf, you need to document the why, the what, and the who. Why the patient is needing custom fit versus just the off-the-shelf. So for example, the shape of their leg or deformity or whatever else that requires more than that. What is actually done? So you must also document that I trim this this many inches or I added this strap or whatever it actually was done as to what. And then who? Can you document that you are a certified orthotist or that you've had specialized training in this? Or a possible example might be an AT. Let's talk about why the world of DME and all of what you do is so difficult. Let's put some frame this into a conversation as far as what is it that makes the world so difficult. So you'll see a couple charts here. The one on the left is previous year's data. And the one on the right is the most current data that we would have. And the dates do look a year off. And that's just due to the fact that the reporting piece is about a year behind. So overall number, and this is what we call the CERT, the Comprehensive Error Rate Testing. Basically what has been improperly paid by the government for healthcare. And there are various reasons for that improper piece. But if you look at the number on the left side, overall number was $31 billion of improper payment amount. So about 7% of things were improperly paid. And if we skip down to the bottom, you'll see DEMI Post, while it's just under $2 billion, so a smaller amount than the Part A, Part B, and the hospital IPPS. It is the largest percentage by far of errors. And now you'll see on the right, the same data and how the DEMI Post numbers have actually gone down, actually improved a little bit. And the reason why I wanted to highlight this right now is because this is an example of why the things are so difficult. There's a lot of improper payments. We've all heard about all the fraud that happens with DME. The government's done a tremendous job in the last several years through the operation Brace Yourself, various things to cut down on the fraud for free, back braces, spine braces, and the wrong things that have gone into all this. So the point is, is that there's still a lot of errors out there and there are a lot of hoops that you have to jump through, but we're going to help you see some path forward on how to improve some of this. Now the previous stat about the DEMI Post improper payment rate, keep in mind that that also does cover several things that are beyond the traditional orthopedic world of DME. That will also include things that you guys might not deal with, CPAP, as an example, nutritional things. But if we rifle in a little bit deeper into the improper payment rates for things that you do deal with, I have an example up here of old, previous year's data and the new data on improper payments. So lower lymphothesis previously was about $188 million of improper payments and almost a 60% rate. That's a staggering number. But as the year has gone by, you can see the improvement in what they have improperly paid for. So that means that people are doing a better job of doing what they're supposed to do on the things like documentation or proper coding or whatnot. But it still is very, very high and they intend to continue to help you make improvements with this and to continue the regulation so that this number continues to trend downward. So why are things being improperly paid in our world? Well, I hope the large piece of the pie, the 59.8% catches your eye. Insufficient documentation. And I hope that if you're going to take anything away from this whole presentation, it is going to be the importance of documentation and doing exactly what is asked of the rules and regulations and standards to get these things properly covered. Yes, medical necessity is a big piece. You've got incorrect coding. You have no documentation or then another category. But let this sink in a little bit. Most of the things that are done wrong are due to not enough or improper documentation. So as you talk to your physicians and providers about, hey, I need this documentation to say this or that, this is going to lead some evidence as to why you're asking for that. This is a very, very important thing that documentation must be done correctly. Again, trying to answer the question, why is this so difficult? I've zeroed in a little bit on some numbers for looking at improper payment rates by the provider type. And if you'll see towards the bottom there, orthopedic surgery, podiatry, improper payment rates for the items that they would prescribe or dispense are some of the higher end items. And you'll see that there's a lot more on this chart that I cut off. But just for the sake of the eyes, I just wanted you guys to get an idea of what the orthopedic surgery and podiatry world has to do with demipost. There's a lot of improper payments on this. Another table here to drive home the point of why documentation is important. You can see a lot of the error categories for lower limb orthoses specifically, and the sample claims that they go through. You can see how important it is for documentation. Medical necessity is also in there. But again, just driving on the point that making sure that you are doing what is supposed to be required in the LCDs is in there, is in your notes and documentation. More stats just to focus in on here. And these are sorted on the left by the dollar value. So what I've highlighted here are a lot of the products that you might deal with. The lower limb orthoses, the LSO, and the upper limb orthoses. The insufficient documentation, the no documentation, just the overall rate of things. You can highlight here why this is such an issue. And to go back to a previous point I made about what other is considered in demipost, you can see all the other items in there that you may or may not deal with. So you can just see how it compares to the rest of the demipost world. It is an issue and it is something that has to be dealt with by that, and that's why we're getting into this conversation. One more eye chart to look at. This is pretty much the same one as the previous slide, but we're looking at percentages here. So you can see why it is so important to make sure that you're getting your providers to put the right documentation in there, because it is a problem out there. Okay, let's pivot into some good news. Very appreciative of this recent decision by CMS to add a new HCPC code, HCPC, Healthcare Common Procedure Coding System. The brace that you see on the right in the image there is an example of what we're talking about. A knee orthosis elastic with condylar pads and joints with or without patellar control, prefabricated off the shelf. This is a brand new HCPC code that is replacing, well, not replacing, it is done in conjunction with L1820. You previously seen L1820, but that is now strictly a custom code. We now have a new off the shelf code. So effective October 1st, 2024, this code went into effect. And if you were using the L299 miscellaneous code, that no longer is necessary. You can use this. So previously for L1820, the code that was before that, the OR02 designation for L1820, that was one, you could see the custom fitted piece in there. So now what they've done is remove the requirements for this, change the verbiage for L1820, and now we have a new verbiage for L1821. So it just basically puts that in an off the shelf piece. Rates are about the same on this. So unless there is a specific patient need, there really is no reason to use L1820, but obviously that's up to your discretion. Also, reminding about some things back August 12th, 2024, Medicare no longer requires prior authorization for L1833. So if this is something you've been doing or you weren't aware of, you no longer have to use L1833 for prior authorization for Medicare beneficiaries. There are new codes that were added on August 12th, L0631, L0637, L1843, and L1845. These are ones that do require prior authorization. We also have some language in here that may or may not apply to you, but just there is no more, there's a suspension as of today, prior authorization requirements for bone growth stimulators. And lastly, at the bottom there, claims submitted with an ST modifier if there's an emergent need and the expedited prior authorization option is not necessarily appropriate. Another reminder, just for the sake of being cognizant, competitive bid was a thing a few years ago. As of this recording right now, it is still in a temporary gap period. So there is no competitive bid modifier KV needed right now. The fees have continued to be adjusted. We might be hearing some news soon about a competitive bid update. And if so, per the disclaimer earlier, then this slide is null and void. But as of right now, the KV modifier is not needed, but we would expect competitive bid to come back at some point. And as we continue the education piece of this, just a, this will be for your reference and benefit, right left modifiers, NU modifier, KX, GA, GY, GZ, and then the KV one that we just mentioned. These are modifiers that are commonly used and you could see the definition of each of them here. Just again, this is provided for educational references and maybe you're seeing some denials based on not having the correct modifiers. I would like to point out right now on the RT, LT, right, left modifier, they are the DemiMax, CGS and Meridian are trying to get away from adding, they would like for you to not put RT and LT in the same line. So if you've been doing that, use separate lines, one line for right, one line for left if you're handing out two knee braces at the same time, one for each knee. This slide is pretty helpful, appreciative of CGS for providing this. I put this on here just to give you guys an idea of how the claim, the journey of a claim actually happens from start to finish. And you can see all of the steps that a claim has to touch and get through and all the things that have to happen in order for it to be successfully clean and covered. And if you don't do something right or if something's missing, you could see how it goes through a roundabout and takes a detour and all the other things. Just to kind of frame a little bit, it is a complex world. The DemiMax do have good processes in place, but they do ask you to follow the steps on it for this to actually make sense. Okay, I'd like to cover the same and similar issue. A lot of you guys are dealing with Medicare not covering a brace for a lower limb or they may have gotten a walking boot and then a few weeks later, they're prescribed a ankle brace just as they're progressing. Those can be denied as similar items and you guys are probably doing a good job of navigating all that. I just wanted to use this slide here to let you know that we are starting to see a lot of issues with upper extremity, same and similar issues. So, patient may have gotten a shoulder brace and then all of a sudden you see a denial because the wrist splint is not covered. Totally different body part, but it is part of the upper extremity. Remember, there is no LCD for the upper extremity and therefore, the processes that they have in place, you may see denials right now. They are working to fix this, I believe, but just know that if you are seeing some denials for upper extremity for Medicare beneficiaries, it's due to the fact that it's just getting caught in the system. If you have the right documentation, appeal it, you should win. And again, this is information I've heard straight from CGS people. Let's talk about advanced beneficiary notice or the ABN usage. These are only to be used if you are unsure if coverage will apply. Whether you use an electronic form or paper form, these are increasingly being used and that is a good thing just to make sure that you're walking through the education with the patient of what may or may not be covered. But I will say this, and this is also what we've heard from the Demi-Macs. If you're blanket ABNing, to use a verb there, that is considered to be a red flag. So, don't use ABNs on every single patient. If you have a different document that you would like to use to help you, you know, cover that or if you need to adjust the fine print and what you're having the patient sign about things to make sure that you're protecting yourself, then that's fine. But submitting and filling out an ABN on every patient and then submitting the appropriate modifier with it is not really a best case scenario. So, just want to make sure that I'm passing along useful information here. And as a disclaimer here, this is not us telling you how to run your DME billing business. This is merely passing along information that we have heard from the payers themselves. So, take that into consideration. Quick reminder about some other acronyms and definitions. A written order prior to dispense, WOPD, that is a completed standard written order, SWO, that is communicated before the delivery of the item. And so, just making sure that you know that for these HCPCS codes that the date of the written order prior to dispense shall be on or before the date of delivery. And a face-to-face requirement must be also in the middle of that. So, just make sure that you're aware of the appropriate definitions here. And so, on the continued conversation of custom fitted versus off-the-shelf, this is what we call a split coding crosswalk. And on the left, you'll see the customizable codes. And then all the way to the right will be the corresponding off-the-shelf codes. So, as an example of what we've already covered so far, L1820, not quite midway through there on the left, is now the custom only code. And now, we cross that over with the L1821. So, as a reference, you can see what is customizable codes versus off-the-shelf codes. Okay. Now, let's cover some specific criteria for coverage that certain codes would need. So, we're starting at AFOs. If we're looking at 4397 as off-the-shelf or 4396 as the custom code, these are the things that are looked for in the documentation. You either need to do 1, 2, 3, and 4, or number 5. So, the criteria must be, number 1, plantar flexion contracture with ankle dorsiflexion on passive range of motion at testing at least 10 degrees, and reasonable expectation and ability to correct the contracture, and contractures interfering or expected to interfere significantly with functional abilities, and component of therapy program, including active stretching muscles and or tendons. Or, if you can meet the criteria to document plantar fasciitis. So, if you're not getting coverage for these, this might be a root cause here. For the codes L1900 through L4361 and then 4387, AFOs are covered for ambulatory beneficiaries with weakness or deformity of the foot and ankle who require stabilization for medical reasons and have the potential to benefit functionally. The keyword in all this is going to be ambulatory. So, making sure that they are able to ambulate to be able to use these braces. If you're going to custom fabricate an AFO or a KAFO, that you need to document that one of these following here, that the beneficiary could not be fit with a prefabricated one, the condition necessitating orthosis is expected to be permanent, or need to control the knee, ankle, or foot in more than one plane, or the beneficiary has documented neurological circulatory orthopedic status that requires. So, if there's something done in the past, or there's a healing fracture that lacks normal anatomical integrity. So, these are the reasons why you can get away with a custom fabricated AFO versus an off-the-shelf one. Okay, let's move over into the knee for coverage criteria. So, the knee orthosis with joints L18-10 or 12. So, again, think back custom versus off-the-shelf that we just did, or the L18-20 or 21. This is covered for ambulatory beneficiaries. So, keyword there. And you have the following, weakness and deformity, weakness or deformity of knee, and you require stabilization. Another rare one there, it would be L18-31 or L18-36. But again, the main ones there would be the ones above. Weakness or deformity of the knee, and that stabilization is required. Moving into L18-30, L18-32, L18-33, and then L18-43, L18-45, L18-51, and L18-52. These are covered if the beneficiary has had a recent injury or surgical procedure on the knee. These can also be covered if they're ambulatory and there's instability noted. So, there's two paths for these very popular codes here. One, a recent injury or surgical procedure, and two, the patient is ambulatory and they have knee instability that is documented. So, let's get into a little bit of that. How are they covered for instability? Well, there is an examination and there must be an objective description of joint laxity. So, simply putting pain or a subjective, my joint is unstable, that will not meet criteria on that. You will need to have a very objective and thorough examination that is documented for these codes to be covered for instability. And again, not the recent injury that we just covered, but this is more for that instability criteria. And if you want to use the custom codes that correspond with those off-the-shelf ones, just like the AFO size, you would need to document deformities, size of the thigh and calf, and there's minimal muscle mass. So, something in there, going back to the why, you would need the custom fabricated. These are the specific languages that they're looking for. More of the same that we just covered there, you can see the criteria that would be needed to have these specific codes met. So, L1830, L1832, L1833, L1843, L1845, L1851, and L1852. Criteria one, recent injury or surgical procedure. It is of note here that CGS, as of right now, determines recent for as three months. Noridian, if you're in their jurisdiction, it is 30 days. So, keep that in mind. And again, if you're looking for reasons why you have denials or more information requested, this could be a root cause as well. So, the criteria number two, again, as a recap, ambulatory and that you can document the instability. And a reminder, L1832, L1843, L1845 are in the custom side of things, and you would need the what, why, who, you need the custom fit code. So, example of evidence supporting joint laxity, if you're going to look for that criteria to be covered. Examples on the left of what are accepted as joint laxity versus the ones on the right that are not covered. So, making sure that you're documenting very objectively and not just saying that the joint is, there's OA in the knee and that's why they need this brace. There must be some instability noted if there's not been a recent injury. RUL, reasonable useful lifetime of the knee orthoses. One year is RULs for those codes, which would also include the L1821. Two years for those ones in the middle, 31, 32, 33, and 50. Three years in the green area, and then three years for all custom fabricated ones. This is obviously the RUL for the knee. Most everything else for ankles and AFOs and upper extremity items and spine bracing will be five years, but for the knee, there are these exceptions made for the five-year RUL. Now, we'll move into coverage criteria for the spine. So, you can see the HCPCS codes there. These would be covered when ordered for one of the following indications. One, reduction of pain by restricting the mobility of the trunk, or aid healing after an injury to the spine or soft related, related soft tissue, or aid in healing after spinal surgery or surgery of related soft tissue, or supporting weak spinal muscles and or deformity of the spine. It is important to note that you do not have to get all four of these for coverage. If you can document one of these, then coverage would be made. But keep in mind, if you're doing Medicare, as we discussed earlier, these would fall underneath the prior authorization pathway. A simple statement in the medical records that the patient has back pain is not sufficient to establish coverage. If you're going to talk about pain, use that first point. But it is important that the medical records contain the need for the brace or the fact that the beneficiary would benefit from the use of a brace. So, examples of some denials that we've seen recently, and we covered this in another slide. Let's use the RT and LT modifiers on separate lines. So, that just, again, what we're trying to do is help you understand some of the why's that you might be seeing on your denials, and to be able to dig through there and see this, this could be a reason. I'd like to use some specific examples that we have been provided by one of the Demi-Macs on examples of why things have not been covered. So, you'll see on the left here, the medical record has a time stamp date of June 6th, whereas the proof of delivery, the patient signed for the device on April 27th. So, this is never going to job in their eyes with the dates are not aligned. If there's eligible documentation, if they can't read it, then it won't get covered. So, just an example of what they see as eligible. If after something is printed out and there is handwritten in some way, shape, or form, there should never be a scribble out, and it should just be a single line through the error, and then the corrected information should be written out, initialed, and dated. If the date is eligible, again, go back to the line thing that I just mentioned, correct date should be just rewritten and a line drawn through it with an initial and date. Make sure that your orders have the beneficiary's name on there to be compliant with the standard written order. So, in summary, we hope that you now can understand the importance of meeting current DME requirements. We also hope that you can discover methods of handling denial challenges, and hopefully, you're now a little bit more prepared for future changes in the DME landscape. Thank you for your time in this conversation. There are some really good references and information to help with. The Dear Physician Letter that CGS provides and Aridian does the same. These links are going to take you to a lot of things to help you do your business better, but I really recommend the Dear Physician Letter because they, this gives examples of what they're actually looking for in determining coverage. Thank you.

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