This presentation is designed to provide accurate and authoritative information on the subjects covered. However, it should not be considered legal counsel and the speakers are not engaged in rendering legal advice or other professional services. That, the agenda for today, we're gonna do the introductions of presenters. We're gonna give you the purpose of this webinar, context for advances in orthotics and prosthetics coverage, some key mobility device coverage and coding advances. We're gonna do questions and answers and parting comments. And with that, hand it over to our speakers to introduce themselves. Thank you very much, Chris. My name is Prateek Grover. I'm an associate professor of physical medicine and rehab at Penn State College of Medicine and an adjunct professor for biomedical engineering. My other roles include quality improvement and research and education. So some of the roles I have are physical medicine and rehab vice chair of quality and safety, a residency associate program director for research and co-director for health system science for the entire university at Penn State College of Medicine. The focus of today is primarily around prosthetics and orthotics and my related work there is director of limb loss and preservation rehab, medical director for the Amputee Coalition and chair of the Amputee Limb Restoration Rehab Community Group at American Academy of PMNR. I also do some work as a member of the health policy practice and advocacy committee at APMR and I co-chair the policy and legislation committee at ACR and these also comprise my disclosures. With that, I'll hand it over to Peter Thomas. Thank you, Dr. Grover and Chris. Appreciate it. Good evening, everyone. I'm Peter Thomas. I am the managing partner of the Powers Law Firm in Washington, D.C. And the firm Powers has represented the academy, believe it or not, for 51 years. That's very rare in Washington. And I myself am a bilateral amputee below the knees and have been using prosthetic limbs, 14 different sets of limbs over the last 50 years. And I've got a fair amount of personal experience but also I represent the Orthotic and Prosthetic Alliance which is a coalition of five organizations all engaged in orthotic prosthetic care as well as the item coalition which I'll talk more about later in my slides. Next slide. I'll just move right into the purpose of the webinar. And that is really to educate physicians on the key advances in Medicare coverage, coding and payment that have occurred in the last roughly two years. It's been building for the last several years but in the last two years, there's really been some advances. To understand how to comply with documentation, medical necessity, requirements related to advanced mobility, technologies to recognize how significant these improvements really are for Medicare beneficiaries and by extension, other individuals who need this type of care covered by other health plans that often will look to the Medicare program as a guide for their own coverage policies. We're really gonna be focusing on prosthetics, orthotics and durable medical equipment. And then finally to illustrate how years of AAPM and our advocacy has helped culminate in a real change through collective and concerted advocacy. The context is important for this because these changes that you'll hear about tonight didn't just kind of happen overnight or happen for no reason. There has been years of pent up demand for advanced prosthetic and orthotic and DME coverage. It's been stymied by fraud and abuse concerns that started way back in the early 1990s. And that's really been a cloud hanging over this entire benefit category that frankly has produced very little change over the last three decades in terms of advanced coverage. There have been investments in advocacy and in research building the evidence base across the last three decades. This has all led to a much more robust evidence base upon which to base new coverage policies and change some of the intractable policies that we've been dealing with for years. The Biden administration has really taken upon itself the goal of health equity and the removal of health disparities. This was included in one of the first executive orders that the current president announced on the first day of his term. And it has really taken hold across healthcare in a very meaningful way. Also the creation of the technology coding and pricing group at CMS, which is really an administrative construct, but it has helped, I'd say, dislodge some of the entrenched individuals and entrenched policies and thinking about this whole benefit. And so it's been really an improvement in both coding and coverage and to some extent payment as well. And of course, this all can't happen without coordinated and joint advocacy, not just from the physician community, but working with the rest of the rehab community, the disability community writ large. But AAPM&R has been a real leader in this area. Thank you. Rakeek. Thank you. I appreciate the background there. So what I'm going to talk about is a little bit of a transition on a background to what Peter will be talking about in more detail, which is the coverage changes that we have. But I want to start with creating the bridge that is needed between aligning patient and clinician perspectives with system and policy perspectives. And one way of doing that is to think about the patient journey within the health system. So when we think about somebody with an acute event, let's say a motor vehicle accident, they will come to a hospital, they will be stabilized and some form of coordination needs to be done for continued recovery. And we recognize that as where physical medicine and rehab and the rehab team plays a vital piece. And then there is transfer of care into post-acute care, addressing functional needs and medical needs. And then yet again, there is transfer of care back to the community with or without DME, with or without services, with or without follow-up, either intentional or unintentional. Now, what we recognize is that this can actually be thought of as a model where these at the top are steps of care delivery, and these are key points of transition. And we recognize that sometimes people will return to the community, will have acute events and come back either from the same incident or from different incidents. But what is also important to recognize is that all of this happens in context of the health system and policy. So two people with identical sociodemographics and other identical injuries and so on may still have very different outcomes and it would depend upon where they are, what they have access to and so on. So there is a very strong interlink between what we do as clinicians and the health system and policies that impact our outcomes. And so let us take the example of a patient journey with limb loss, which is related to what we'll be talking about, prosthetics. So if we see somebody with a foot that looks like that, oftentimes they may end up getting a surgery that results in limb loss and the limb should heal. Once it heals, we hope that they're able to get a prosthetic device. We work towards that. And then our ultimate goal is a good quality of life. So if we take the patient's perspective, what it means for them, it really means surgery, limb healing and rehabilitation, prosthetic prescription, learning how to use the prosthesis, and then finally back to good community functioning. But if you think about it from the system perspective, it looks very different. So in other words, let us think about somebody who had limb loss surgery and received post-surgical care. Let us say that we start with 100 patients in a year. Not everybody gets rehabilitation prior to receiving the prosthetic device. In other words, pre-prosthetic rehabilitation. So let's say that number drops to 80. Of those folks, not everybody will come to a PMNR clinic or go to their primary care for a prosthetic prescription. So that number now goes down to 60. Of the folks who get a prosthetic device, not everybody will get access to good quality rehabilitation. Some may choose not to complete it, but a majority may not have access to it. Now that number goes to 40. And then following them back up in clinic, as and when needed, that number may go down even further. And we don't really have a good understanding of what the quality of life looks like. So as you can see, this journey from a system perspective looks very different than a patient perspective. And this is where policies and the health system come in pretty strongly. This is where the role of rehabilitation and prosthetic devices and advocacy around them becomes really important. So one way of doing that, and I will not spend much time on this slide, is to think about actually designing frameworks for implementing rehabilitation programs. And so essentially, we take that very same journey and take the steps, post-surgical stabilization, pre-prosthetic rehabilitation, limb healing and maturation, prosthetic fitting and prosthetic rehabilitation. We can now start quantifying what is happening in each of these. We can measure them. We can think about the stakeholders. We can think about the systems. We can think about the individual policies. And then based upon that, we can now start implementing interventions that help with each of these pieces of the journey. So I can tell you my experience at Penn State Health. I've been here for just about a year and a half, and we developed a program based upon this LLRC framework. We have seen that the attrition, which went from 100 down to a 20, as we said anecdotally, that attrition has decreased. In other words, with a coordinated program, we are able to have more people come to inpatient rehab, more people getting a prosthetic device, more people getting rehab with a prosthetic device. And we are just starting to understand what their quality looks like. The delays are better as well. In other words, if somebody was getting a prosthetic device in six months, and I'm sure we as clinicians have all seen people who have been lost to care and come back to us, they are getting it in a more timely fashion. So that's the impact of coordinated care. Where does insurance come in? Besides devices, which we'll talk about, it also comes in terms of rehabilitation. We are still struggling as far as insurance is concerned, especially categories like Medicare Advantage, where both pre-prosthetic rehabilitation and prosthetic rehabilitation delays exist, primarily related to insurance. On a positive note, and some of the policies that Peter's gonna talk about, we have found more success in being able to get people the prosthetic components like NPK knees or K2 level that was not happening before. So the technology that we're gonna talk about today, prosthetic devices, which as we recognize replace function, we'll talk about NPKs, we'll talk about upper limb devices and bone anchored prosthetic devices. Orthotics that augment function, we'll talk about powered orthotics. Wheelchairs that assist function, we'll talk about power wheelchairs, and then supplies, we'll talk about catheters, referred together as DME POS or durable medical equipment, prosthetics, orthotics, and supplies. And so the definition of DME POS or DME itself is a five-pronged definition. It should be durable, which means it can withstand repeated use. It should be primarily medical in nature. It should not be useful in the absence of an injury or illness. It should be useful in the patient's home, which we recognize can be a challenge because people will go out and they should be able to utilize devices outside. And then they should have a reasonable useful lifetime of five years. We see three for prosthetics and so on. So there are different definitions there. And then two definitions to clarify. One is orthotics and prosthetics, which refers to artificial legs, arms, and eyes, and rigid or semi-rigid braces that are used for the purpose of supporting or restricting or eliminating, depending upon the indication, as distinct from prosthetic devices, which can refer to both internal body organs and external body members. And the thought here is replacing a part or replacing function. And so the access to this, Medicare is the standard for coverage that many payers use for guidance. Coverage, coding, and payment are the three distinct requirements. The first step is always benefits category determination, and that is followed by the determination whether the device is reasonable and necessary. And it is antiquated, yet it's a key benefit that sets the stage for access to devices and technologies. And so here is a brief graphic on coverage, coding, and payment. And I can read it out to you, but I think Peter will be able to explain this better. So I'm gonna hand it back to him to talk a little bit more about this. And then he'll follow it up with the item coalition and some other details. Sure, thank you, Prateek. So in terms of access to assistive devices and technologies under the Medicare program, and pretty much under any payer, there really are three main areas of activity. And as an advocate, as a lobbyist trying to assist clients to get through this process, in many instances, you can hit a real pothole in the coverage area, or you can do very well in coverage and get really compromised on coding, or you can do well in both of those areas and then get a payment level that just doesn't make ends meet. And so with respect to coverage, this occurs largely through Medicare manuals, the NCDs or National Coverage Determinations, local coverage determinations, or LCDs. Something that explains the LCD is typically referred to as a local coverage article. Those are easier for the DME MACs, which are the medical directors who administer this benefit to change or to modify. An LCD and an NCD have more strict procedural criteria. And then other guidance documents that CMS issues. With respect to coding, you're all familiar with the level one coding CPT process and that code set, but there is a level two code set that's referred to as the HCPCS code set or the Healthcare Common Procedure Coding System. And that essentially is used for all durable medical equipment, prosthetics, orthotic supplies, and outpatient Part B drugs. And then finally payment. There is a regulation that regulates how new codes are assigned a reimbursement value, how you crosswalk from one existing code to a new code, or whether you have to gap fill, which is an antiquated process that results usually in reimbursement levels that are simply much lower than the new technology would suggest. Next slide. So I mentioned the Item Coalition a moment ago. The Item Coalition has 101 members. We started it at Powers in 2003 with respect to the IBOT mobility system, which is pictured here on the right. That's a device back in the early 2000s that elevated onto two wheels and then balanced with the use of gyroscopes. It climbed stairs, it descended stairs. It raised the seated user to a standing level and it actually balanced even when moving. An amazing device. But Medicare did not wanna cover this device. And in the end, they didn't wind up doing it. They broke it down into a series of codes and it kind of sputtered for some time. Johnson & Johnson was the company that had invested in this and was responsible for starting the Item Coalition, but we've run it ever since they got out and away from the IBOT. And ultimately the coalition is thriving. We've got a large group of people and organizations that are involved, a steering committee that does the heavy lifting on a day-to-day basis and a number of different funders that contribute to enable us to do what we do. But it's got a strong consumer focus and we really have made great strides. I encourage you to go to the website, itemcoalition.org. AAPM&R has been a longstanding member of this coalition. So let me first talk about new microprocessor knee technology and the local coverage determination that just went into effect on September 1. So on January 18th, 2024, CMS and the DME MAC medical directors, they published a proposed local coverage determination for public comment, kept it open for 30 days and everyone commented, AAPM&R commented, many of the other organizations and of course lots and lots of physicians and individuals commented. This was a proposal to expand coverage of microprocessor fluid and pneumatic knees, prosthetic knees to a new cohort of patients, a less functional cohort. Currently and since 1994, microprocessor technology was available to K3 amputees or functional level K3 amputees and K4 amputees, most of which Medicare does not cover those devices for K4. But for K2s, they prohibited coverage of MPK knees. And the reason really dates back to the early 1990s when there were some Office of Inspector General reports that suggested that certain DME companies were going around to nursing homes and fitting everyone they could with a microprocessor knee and they were not being used. They were being overused in fact and abused. And so they made the decision to only permit microprocessor knees to people who were considered unlimited community ambulators or K3 amputees. This policy proposed that they extend microprocessor technology to K2 amputees which is generally known as limited community ambulators. AAPMNR submitted comments, the Item Coalition submitted comments. It was a wonderful advance and we hoped it would go into final effect. Next slide. So on January 18th, the final policy was issued, LCDL33787 for lower limb prostheses. They also issued a local coverage article. They in fact did go forward and expand for Medicare beneficiaries at the K2 level, access to and coverage of microprocessor controlled knees including fluid and pneumatic knees. Again, limited community ambulators who require a prosthetic knee based on the best available evidence. And this did go into effect on September 1. Next slide. So this is new coverage. It was designed to prevent or to lessen the rate of falls, the risk of falling, fear of falling and gait performance with MPKs. Now, you know, when an amputee, when a person with a limb loss is unsure about where their next step will be, or is unsure if their knee begins to buckle, whether they'll be able to recover, they become much less functional. They become much more timid in their gait patterns and are reluctant to engage in more active activities or climbing stairs, descending stairs and the like, because they just don't know if they're going to wind up flat on their back, you know, in the next moment. So this is why these MPKs were extended to this beneficiary population. And it's essentially, it's based on the evidence. There have been quite a few studies over the last 25 years that have demonstrated that this patient cohort can very much benefit from MPKs in a manner that was not assumed in the early 1990s. The final LCD clarifies that not all non-MPKs must be ruled out before a K2 beneficiary can access an MPK. It's just kind of a situation where you try to figure out whether a non-MPK will work for a particular beneficiary. And if you conclude as a professional that they really can benefit from a microprocessor prosthetic knee, then they have access to it. As long as you do certain things, you got to document, you got to make sure that you're following the rules that they've laid out in the LCD and the LCA. So not only are prosthetic knees covered for this patient population at the microprocessor level, but also compatible feet for this same population. So they've coupled the foot and knee components, recognizing the holistic approach to prosthetic care. There are certain modifiers that are listed there that you'll be using, or actually the prosthetist more likely will be using when they submit claims for these prosthetic limbs. Next slide. So what does the documentation need to include? And by the way, back in the 2018 timeframe, prosthetists and orthodists were granted the authority under the Social Security Act that their notes, their clinical notes are relevant for the medical necessity determination. Many of you might think, well, of course they are. Why wouldn't they be? They're the person that most closely aligned with the prosthetic care and takes explicit prescription and direction from the physician or the rest of the rehab team. But prior to that passage of that law, that was not the case. Their notes essentially, because they were suppliers, their notes were not considered part of the medical record, if you can believe it. That's changed now. But the documentation has to include, and this needs to be in the physician's file as well. It's got to be corroborated by the physician, not just in the prosthetist's notes, how the MPK will improve the beneficiary's functional health outcomes. So you've got to take the time to write down in the patient's file, how is this going to improve the beneficiary's functional outcome? How is the MPK going to help the beneficiary accomplish their activities of daily living? Specifics. Other lower limb or lower level knee options have been considered and ruled out. You've got to make an affirmative statement to that effect, or you've got to demonstrate that we've looked at that, we've examined it. Maybe you've talked with the prosthetist and those have been ruled out based on the individual's functional and medical needs. The microprocessor knee has to be provided. It must be indicated for K2 amputees and include integrated technology that allows stumble control, automatic resistance in the knee to prevent falls. That's a key element of this coverage policy. Now, luckily, or I guess coincidentally, virtually every single microprocessor knee helps prevent falls. There may be one or two that don't, but the vast majority are designed with that feature in mind. And finally, the beneficiary is able to make use of a product that requires daily charging and the patient can understand and respond to alerts and alarms, which may indicate knee dysfunction. These are individuals who have some cognitive capacity and understand how to take care of a limb. Next slide. You're probably familiar with the functional levels because prosthetists and orthodists have a role to play, primarily prosthetists, in assigning a functional level. Really, it's the physician that has to consult with the prosthetist if they wish to and ultimately make the determination about what functional level that individual is either performing at or has the potential to perform at. That's an important concept. The functional level is one where the beneficiary can attain and has the potential to be at that functional level. It's not necessarily where that person is today. And the reason for that is because you don't want to hamper that individual's functional assessment by the technology that's holding them down now. You want to give them the benefit of the doubt that if they had better functioning limbs, prosthetic limbs, that they'd be able to perform better functionally overall. So the local coverage determination has certain specifications in the document requirements. When submitting a prosthetic claim, the build code for a knee, foot, ankle, or hip components must be submitted with a modifier, K0 through 4. Again, K3 is unlimited community ambulator. K2 is a limited community ambulator. K0, you don't get access to a prosthesis. These are people that are just not good prosthetic candidates. They're not motivated to ambulate. They don't need a limb to transfer. And that's the end of that. K1 is kind of a combination between K0 and K2. And K4 is someone who's running marathons and doing all kinds of things, or a child or an athlete. So you need to determine a functional level with respect to a Medicare beneficiary. And the LCA gives additional guidance to physicians and prosthetists in making this assessment. There must be information about the beneficiary's history and current condition, which supports the designation of the functional level by the prosthetist, the orthodist, I'm sorry, the prosthetist, the physician. New details and guidance to physicians and prosthetists are in the new policy. The article creates, let's see, regarding selection. Okay, so it does provide some specifics regarding the selection of functional level and the recognition of special treatment for bilateral amputees continues in the policy. For bilaterals, the functional level is often more flexible than a unilateral amputee. And that continues in the local policy article and LCD. The LCD actually contains the language. It's no longer in the policy article. Next. So the medical records, documentation of a clinical evaluation of the beneficiary's potential functional abilities, which demonstrates K2. That's what's required to be in the medical record. The beneficiary's overall medical health and rationale for a fluid pneumatic or MPK knee. Which functional health outcomes, fall reduction, injury prevention, lower energy expenditure are expected to be improved and specifically which activities of daily living, transferring, climbing stairs, grocery shopping, housekeeping, working. You need to try to be as specific as you can in the clinical file, clinical record of the patient. So when the payer comes in and looks at these documents, the prosthetist is able to continue to keep their payment for the prosthetic care. And you're able to keep your payment for your physician services that you provide to the beneficiary. The documentation of support that all non-MPKs have been eliminated as options. Yeah, thanks. We're good there. We've already covered that. In terms of additional requirements, the claims for an electronic microprocessor knee for beneficiaries who's functional level two, it also needs to include documentation that the MPK is indicated for functional level two and has that integrated technology that allows for stumble recovery. So I gave you earlier some of the requirements for what has to happen in order for an amputee to get access to these new advanced knees. But this is what actually has to be in the file and in order for it to be paid. And then documentation indicating that the beneficiary is able to make use of the product, as we've talked about before. Next slide. OK, so here's where the local coverage article goes into additional documentation, additional detail on what a physician and the prosthetist can write in their file to demonstrate who is a K2, who is a K3. So for a K2 individual, the person has the ability or potential for ambulation with the ability to transverse low level environments such as curbs, stairs or uneven surfaces. And this is typical of the limited community ambulator. So that's who we're talking about by a K2 amputee. Then they go in, they describe this a little bit more in depth. They say that individual can with or without assistance. Remember, you don't consider whether they use a cane or a crutch or whatever it might be. They have to perform the following performing level one tasks. So those are just safe ambulation in the home. That's K level, K1. So that's kind of a given. And then added things to make you into a K level two would be being able to ambulate on a flat, smooth surface, concrete, asphalt, a porch, a patio, a driveway. How to negotiate a curb, how to access and actually access public and private transportation. Negotiating a stair or two and negotiating a ramp built to ADA specifications. And that's one inch rise for 10 inches of horizontal length. So it's one in 10. Pretty low level barriers. Next slide. But the LCA continues and also says that the individual may require a wheelchair for distances that are beyond the perimeters of the yard or driveway or apartment building. An individual may only be able to increase their generally observed speed of walking for a short distance or with great effort. They may generally not be capable of accomplishing most of the tasks of a K3 level amputee who is a unlimited community ambulator. And these are, you know, more detailed descriptions of the K level system that should help prosthetists and in particular physicians identify better exactly who's a K2 and who's a K3 amputee. Next slide. All right, back to you, Dr. Grove. Thank you. Appreciate it, Peter. So I briefly want to make the connection between what Peter described and what we as clinicians should be documenting. I'm sure a lot of people already do this. But in terms of clinic visits, especially when we are looking at the prosthetic device, prosthetic rehab and any sort of community rehab, the framework I end up using is the World Health Organization International Classification of Functioning. So you see the functional domains lifted here on this table on the left. We have impairments, activities, and participation. And on the right, we have got our recommendations and prescription. And the three levels of function that are important to document are the function before limb loss, the current function with limb loss if we are seeing them in clinic before they receive a prosthetic device, and an anticipated function with the prosthetic device. So talking about impairments, the pre-amputation function in terms of physical and mental health is important to describe. That can be connected with current impairments for limb loss. As Peter mentioned, those could be related to energy requirements. They could be related to pain. They could be related to volume changes and hence changes in the dose of medications and so on. So lifting those impairments. And then anticipated function is where the prosthetic candidacy comes in. So there are two pieces to this. The first is, is the patient a good prosthetic device candidate? That determination needs to be made. That is where the K0 level comes in. And if they are a good candidate, then what is their functional level in terms of impairments? That is where the components come in to be able to help that. And that helps us prescribe the prosthetic device. When we start looking at activities, pre-amputation function in terms of daily activities, mobility and cognition, which we highlighted, which is vital for people to learn how to use a prosthetic device and use it safely, is important to document. Any changes with limb loss, the activities should be documented there. And then the goal really is to try and match pre-amputation activities with anticipated function. And that is often very helpful to think through levels. So even though we don't officially assign a pre-amputation functional level, we can. So let's say if somebody was a K3 in the past, currently with trauma, they are at a K0 or a K1. Their anticipated function could still be a K3. So understanding those prior functional activities becomes really important to do this. In addition to prescribing the prosthetic device, this is what helps us also determine what the optimal setting for prosthetic rehabilitation would look like. Should they be coming inpatient with a higher level of amputation? Should they be going outpatient if they don't have much medical complexity and so on? And then the third piece, which I think is vital, is documenting participation. What were they doing for personal activities before they lost their limb? What were they doing for social activities? What nature of work did they do? What recreational activities did they do? How are all of those currently affected with limb loss? And then how do we actually want them to go back to that? And what can we actually do in that regard? How do we help them get back to driving? How do we help them with community resources, vocational rehab, and so on? This is where clarifying goals and expectations becomes really important. It is really important to set short-term expectations as opposed to long-term expectations. And the reason is if expectations are not set properly, the wrong prosthetic components could be prescribed if somebody doesn't recognize that, and that can in turn impact mental health for people if they receive a prosthetic device that they cannot properly use. So all of this together essentially should be reflected both in the visit, which in my case my clinic visits are anywhere from 45 minutes to an hour, but it also needs to be reflected in documentation. So I have a templated version of documentation, which I know a lot of folks frown on, but it helps me get through all of these tenets. And then the prosthetic documentation in that case collaborates a lot of what I write, but it's not exactly the same, which helps us get to an agreement on K-levels independently as two different disciplines and yet being able to get to the same K-level based upon the same things that we are hearing. That in a nutshell is what I do with this documentation, and with that, I'm going to hand it back to Peter. Thank you, Prateek. Okay. So clearly a big victory on lower limb microprocessor technology, access to that benefit. It went into effect on September 1st of 2024. So if you do have Medicare patients who have real fear of falling, they're timid on their prostheses. Maybe they haven't even embarked on having a prosthesis because they're too afraid. I would most definitely consider exploring microprocessor technology for some of those beneficiaries. But there's also developments in other areas, including upper limb prosthetic coverage, or I should say coding. Upper limb prostheses are covered under the Medicare program, but the code set, if you really understand and work a lot with upper limb amputees, the code set is really quite outdated. There's been a tremendous amount of technologies that have been brought to bear in upper limb prostheses, and the code set has really fallen way behind and has not kept pace. There's a number of codes that could easily be eliminated and no one would know the difference because the codes are rarely if ever used. And then there's a bunch of new technologies that are not reflected at all in the code set. So CMS did retire some coding guidance in 2023 as a result of some complaints that it was being applied in a restrictive manner and was preventing beneficiaries from getting what they needed. And they've embarked upon, at the behest of the Upper Limb Society of the American Academy of Orthodontists and Prosthetists, an effort to try to update the code set. So there was a 12-code set of descriptors that the Upper Limb Society submitted on July 1st. CMS came back and said, we don't like the changes that you're suggesting, but we do recognize that this code set is outdated and needs to be improved, particularly for people who are missing a part of their hand or fingers. The partial hand prostheses and finger prostheses have not kept pace at all in the code set. And yet they're clearly upper limb prostheses. They're covered. They're just not well coded. They've proposed, CMS has proposed seven new codes for upper limb prostheses to address the lack of codes for people with partial hand and finger amputations. The jury's not a little bit out on this one still, because the preliminary hearing on this is not until the 8th of November. There are some problems with the seven codes that they've proposed. But ultimately, this is progress. This is moving forward. And I expect additional progress in the future on upper limb coding. Next slide, please. Bone anchored prostheses, what many of you may have heard of as osseointegrated prostheses. Over 500 people around the country now have OI or bone anchored prostheses. These are pretty incredible to take a look at a patient who has gone through this surgery. It is a surgical procedure. It does take a fair amount of time to have the bone heal, to have the abutment exit the skin, and to manage the infection potential there. My understanding is that the infection potential is somewhere between five and 8%, according to the data. But ultimately, for people who do not adapt well to traditional socket technology, bone anchored prostheses are really a godsend. I've seen a number of amputees, some friends of mine, and others who have gotten access to this technology, and they're really able to do incredible things with this new fitting technique. Luckily and happily, CMS did agree to create a new HCPCS code, L5991, for an addition to lower extremity prostheses, osseointegrated external prosthetic connector. So what's covered now is the connector that would connect the abutment, or the pylon that exits the skin, to a connector, and then the external prosthesis would be connected to the connector. And so the rest of the prosthesis, essentially, is the same as the other kind of components. Now, there is a problem, and there's a couple of problems with this. It's kind of incomplete, but this is happening in real time. There is no base code, and that's a prosthetist's problem. You can't just have a series of add-on codes and create a prosthesis. You've got to have a base code, and yet each one of the lower limb base codes contain a socket. They describe the creation of a socket, and there is no socket with a bone anchored prosthesis. So we've got some additional work to do on coding, but bottom line is, we also have some additional work to do on the surgical piece to this, because right now it's being billed under certain codes that are not specifically designed for osseointegrated prosthesis. But bottom line is, they're moving toward covering this through the creation of that new code. Osseointegrated prosthesis, I think, offer a very good option for some beneficiaries, but certainly not all amputees. My personal view is, I would never get a bone anchored prosthesis. I've been using sockets for 50 years, but I adapt well to sockets. There's plenty of people who don't, and this is a really important option for that set of patients. Next slide. The next, one more. The next benefit that really has been an incredible advance one more slide, is a powered orthoses. For some time, the Medicare program did not consider power added to an orthoses to be an orthoses. They didn't feel as though it supported a weak or deformed body member or restricted motion in a lower limb or an upper limb. And so CMS was looking at determining that any power added to an orthoses would be considered not a non-benefit. It doesn't fit into a benefit category, or it would be durable medical equipment. And then you've got a problem with rental, and you've got a problem with the in the home requirement. Clearly, these types of powered orthoses are meant for use both in and outside of the home. So we were very glad to see a regulation come out in June of 2023, that codified the definition of a brace as a rigid or semi-rigid device used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body. But it also included power as an orthoses. Next slide. And on August 22nd, AAPMNR and the item coalition both submitted comments supporting the regulation and ultimately CMS determined that power applied to orthotics is a covered orthotic benefit under the Medicare program. This opens up and lays the foundation for a whole new family of powered orthoses to be covered by Medicare and by extension, other healthcare payers. So not to use specific brand names for any reason other than to just describe exactly what we're talking about here. You may have heard of the Myomo devices from MyoPro for people with stroke, upper extremity. You may have heard of the Rewalk or the, I believe the name of the company now is LifeWord, but the Rewalk device, the exoskeletal powered orthoses. Those are considered covered orthotics under the Medicare program as of that decision. Next slide and then I'm wrapping up here. Coverage of seat elevation in May of 2023, the item coalition after several years of having submitted a national coverage determination and working with Dr. Anjali Shah and AAPMNR member and a whole host of other individuals we were successful in getting CMS to issue a national coverage determination for seat elevation in power wheelchairs. That's so rudimentary and basic a function for a person who needs a power wheelchair. It's absurd to me that it took until 2023 for the Medicare program to cover that benefit but they finally have. And they did it in a very broad way. They covered the benefit not only to improve the reach of an individual in a power wheelchair but also to improve transfers from one surface to another whether or not the beneficiary has a lift in their home. So it really came down to the evidence base talking about how seat elevation improved the safety, improved the function of transfers and improved MRADLs, mobility related activities of daily living in the home. And that's the coverage policy for power wheelchairs. And so seat elevation is now a covered benefit. In the last six months of 2023, we're aware that at least 5,000 claims were paid under the Medicare program. I don't have new data on 2024 but I can imagine it's increased considerably since then. So big victory and the AAPMNR was very much involved in that decision. And then finally on the supply front, muted myself somehow. For years, 1,300 different types of catheters, intermittent urinary catheters were coded with just three codes, a straight tip catheter, a coude tip or a curved tip to get around for instance, a stricture or a enlarged prostate and a sterile kit. Those are the only three codes that you could use for catheters. And these are extraordinarily important for patients with spinal cord injury, paralysis, all kinds of conditions and disabilities. Hydrophilic technology is a technology where a certain type of lubricant is impregnated into the skin of the catheter and it only is activated when it becomes wet. And it's very easy for beneficiaries to use these catheters. They're considered the gold standard but there was no separate coding for those catheters and finally CMS has agreed to create a new codes for hydrophilic catheters. They won't go into effect until January 1, 2026 and they will be paid the same as the existing codes. So they determined that there was a lesser risk of UTIs, urinary tract infections with hydrophilic catheters and they will be covering them and coding them differently in the future. So you'll be able to give your patients a more specific prescription and ensure that the suppliers provide hydrophilic catheters if you believe they need them. The final slide that I have is not even related to personal mobility equipment or devices. It's more related to some rules that came from the Affordable Care Act and from the Rehab Act of 1973. It's non-discrimination provisions based on disability in the provision of health insurance. That's the 1557 rule. It was issued in April of 2024. That provides general non-discrimination requirements under the Affordable Care Act. 504 was also re-regulated in May of 2024 by the Biden administration. That provided for accessible medical diagnostic equipment that if you don't have that in your offices, you're going to need to comply with some new requirements. By this point, 34 years after passage of the ADA, I highly doubt many of you don't have some kind of accessible examination table or weight scale or whatever it might be, but those new requirements are in effect and they are enforceable by the Department of Justice. There's also non-discriminatory medical treatment decisions and regulations on that and regs that prohibit the use of value assessments that are discriminatory, usually based on disability and kind of normative judgments of the life of a person with a disability. Web accessibility is also another set of regulations that the Department of Justice and DOJ and HHS issued recently, and that will help people with disabilities gain access to kiosks and websites and other kinds of things to enable or help enable telehealth. Dr. Grover, back to you. I believe that was the last slide. So I think we are done with the presentation and we are happy to take any questions. Scott Brown asks, our experience is that Medicare won't pay for both a power wheelchair and a prosthesis. There's no rule that says that. I can most definitely see an instance where a person would want to have both a prosthesis and a power wheelchair. Frankly, some people that do use prosthesis are not particularly comfortable on them. There are questions, of course, about whether they're seeing the right prosthetist or not, but assuming they are, and they've just got a residual limb that's got all kinds of problems with neuromas and bone spurs and all kinds of things that can't otherwise be surgically improved, I can most definitely see the need to have the ability to walk when necessary and when one wishes to engage in walking and one needs to rely on a power wheelchair. So I would fight that one through the appeals process. There's certainly no requirement that you cannot get access to a prosthesis if you have a power wheelchair. Yeah, Peter makes a great point. My clinical approach to that is that a prosthetic device is going to be much more expensive, so that is the right place to start. So what I do in my clinical evaluations is we discuss it, we make a case, we prescribe a prosthetic device, we set up an appointment for another two or three months, and at the next one, I prescribe a motorized wheelchair, which gives people enough time to get the prosthetic device, and then at that point in time, we can make a justification for the wheelchair as well. Trying to do it the other way, the challenge that I have seen, and I haven't seen it personally, but I've heard from colleagues, is that if you have a wheelchair, they say you should not be using a prosthetic device. So I flip it around, start with a prosthetic device, then go to a wheelchair. You have any comments regarding the denial of Medicare-appropriate requirements for DME and rehabilitation services by the so-called Medicare Advantage insurers? Oh boy, Medicare Advantage. So we're now at 50% of the Medicare population is covered by Medicare Advantage. They are notorious for imposing prior authorization on everything that they can possibly impose that on. They're being chastened. The health plans are under fire. There's just a report that came out in the Senate just on past Thursday that vilified UnitedHealthcare, Aetna, and Humana for dramatically overusing prior authorization, particularly in post-acute care. It's a real problem in MA and in Medicare Advantage, and it will continue to be a problem. I think there are new rules that you can use to try to push back. They can't use algorithms. They can't use AI. They have to follow the Medicare fee-for-service coverage rules. They have to have educated policy makers or decision makers on approval of services, but that's a whole bill. We could spend another hour talking about that one. I would agree with Peter on that. I will tell you my challenge with Medicare Advantage is not so much prosthetic devices. If you have good documentation and you have your prosthetist in the clinic with you, which is what we typically do, prosthetic device coverage, as long as the prior function, current function, and anticipated function is well-documented, prosthetic devices will get covered. My challenge is more with pre-prosthetic rehabilitation and prosthetic rehabilitation, where I'm doing peer-to-peers, people are talking with me, the medical directors on the other end, saying, thank you, we agree with you, but we are not going to approve it because it says so in our rule book. So that is a difficult one to work on. But to Peter's point, I think there is a lot happening nationally that is trying to address it more at a system and policy level so that they stop denying care that is appropriate care. One, another good question here on the length that a prosthesis should last. My personal experience is typically between three and five years is fairly typical. I've used prostheses for as long as 12 years, but with routine maintenance, I probably went through two or three different feet, but I'm talking about the basic socket, the basic pylon and the like, maybe cleaning them out and updating the stoppers and lubricating them and such throughout that time period. But they can last a fairly lengthy period of time if you're stable, if your weight is stable, if you're not having any medical complications, if you've stopped growing. But most prostheses will last between three and five years. There is an exception to the reasonable useful lifetime requirement for prosthetics so that if a beneficiary can demonstrate through their physician's documentation and the prosthesis documentation that there was a change in the patient's condition, you can get access to a new prosthesis or a replacement socket or whatever you might need. Yeah, I would agree with Peter on that. So I would say when you're looking at feet, I find that feet last the longest, followed by knees. And then sockets, I would say you can change them as frequently as needed. In other words, you'll find in the first couple years, the residual limb actually shrinks quite a bit. So it is not unusual for us to change sockets, two to three sockets in the first couple years. Sometimes that happens when people are doing prosthetic rehab, they're already using eight ply socks. So I'll see them in another month or two in my clinic and I'll prescribe a new socket. And we never get any sort of challenges with that. Socks and liners, I would say, should be changed every six months. If people are using them regularly, they are ready to be changed every six months or so. Changing liners with the sockets is not unreasonable either, even if they are not that old. My apologies, my dog's in the background. Microprocessor knees and others are typically covered for three years. And so are the feet. So you'll find warranty covers them for three years. If your prosthetic discovers delamination or you have some challenges with your microprocessor knees, to Peter's point, you can always talk with the company. They can try to service them. If the servicing is not going to work, they can be replaced. But it is the knees and the feet where you'll find a little bit more fight. But I agree with him, overall, three to five years for those components is pretty typical. We're at the end of time, but let me quickly answer a couple of questions here in the chat. For specific documentation requirements involving socket replacement, suspension, sleeves, liners, it's all in the LCDs. It's all in the Medicare and DME MAC policies around lower limb prostheses. Just go straight there and you'll find it. In terms of getting patient access to inpatient rehab hospital care, the Academy is working on that issue right now because we're noting a new trend where they're saying if you don't have a prosthesis, you don't get into an IRF. But if once you have the prosthesis, you no longer need hospital-based care. And this is one of the 60% rule conditions. So that's a real problem. We're writing a white paper on it and we're pursuing that. And Dr. Grover is going to be helping with that, I understand. So what else? I have seen cases where Rewalk and MyoPro are being covered, including with Medicare. It's starting. It's in the early phases, but certainly Veterans Administration and private care, private insurance have covered those for some time at this point. I think we have to end. Is there one more question from Mary? I think the last question is, has anyone else had a problem with auto primary covering 9-1-2-1-5 visits? I have a new problem review of a denial. The reason listed is that the code is not usually required more than once during their care. I will say, I have not heard that. Are we talking clinic visits? Yes, I have many amputees. I have accumulated over the years since 96, leaving Henry Ford Medical Group. They are traumatic, so they live. And in the last couple of years, a couple of them that needed revision, which hasn't happened in a long time. So they're a longer visit and they've just frankly denied it. They haven't downcoded. And I have several visits that either, I'm still seeing them, but I'm frustrated and there's really no one I've been able to go to. I'm in Michigan. They just switched the no-fault law to go on Medicare. And that's why I'm asking about, okay, I need to learn the Medicare rules, which I haven't had to use for these patients, so. Yeah, thank you for sharing that. I think that is very insightful. Maybe this is a crop of new things that we will see. But I will say that most of my visits are 214s and 215s, sometimes 213s. And I'm in Pennsylvania and we have not yet seen that problem. Thank you. Chris, I think we need to draw this to a close. We're over our time period here. That is correct, Peter. So thank you to everyone for joining tonight. Thank you, Peter and Dr. Grover for presenting. If you have additional questions that were not covered here or were not fully answered that you've already put in the chat, we will get you a response. If you have additional questions that come up, please email AAPMNR at healthpolicyataapmnr.org and we will get you a response. So thank you all for joining. Have a great rest of your night. Thanks, everyone. Thank you very much. Good night now. Have a great night.

orthotics

prosthetics

Medicare

microprocessor-controlled knees

K2 amputees

osseointegration

powered orthoses

rehabilitation medicine

prosthetic prescriptions

insurance challenges