How Changes to CTPs Could Impact Providers and Patient Care

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Brian McCurdy:
Welcome back to Today's Wound Clinic podcast, where we bring you the latest practical treatment and reimbursement information for leaders in the wound care field. I'm Brian McCurdy, the managing editor of TWC. Today we're talking about cellular and tissue-based products for wounds. The Centers for Medicare and Medicaid services recently made some changes to CTP usage taking effect September 17th, which could interrupt patient care with me are some members of the Alliance of Wound Care Stakeholders to discuss the impact. Welcome. Why don't each of you breach? Why don't each of you briefly introduce yourselves to the audience?

Marcia Nusgart, RPh:
Hello, my name is Marcia Nusgart and I'm the Chief Executive Officer of the Alliance of Wound Care Stakeholders.

Karen Ravitz, JD:
And I'm Karen Ravitz, and I've been the health policy advisor for the Alliance of Wound Care Stakeholders for over 15 years.

Kara Couch, MS, CRNP, CWCN-AP, FAAWC:
I'm Kara Couch. I am director of Wound Care Services at GW Hospital in DC and I am the co-chair of the Alliance.

Marcia Nusgart, RPh:
Brian, thank you so much for allowing us to be able to spend this time with your listeners. The Alliance of Wound Care stakeholders is a nonprofit, multidisciplinary trade association of physician specialty societies, clinical and nonclinical associations, patient organizations, wound care provider groups, wound care clinics, and business entities. And we are the unified voice for the wound care community to advocate on public policy issues such as this that might create barriers to patient access to treatments or care. So we focus on key areas, appropriate coding coverage and payment for wound care products and services, quality measures and wound care research. And most importantly, and that's the reason that we're coming together today as ASRA listeners to do what we do is to advocate for appropriate payment and coverage for wound care products. And we're going to address an issue that, as you mentioned, does impact cellular and or tissue-based products for skin wounds. So we leverage the expertise of our clinicians and clinical association members to influence regulatory agencies and decision makers.

Karen Ravitz, JD:
And it's also really important to note that in this space for the cellular tissues, the policies that are being issued are not by CMS National, but actually they're local contractors, which are the Medicare administrative contractors. And the issuance of the local coverage policies has really changed over the years. And these MACs are no longer seeking the kind of stakeholder engagement or even using carrier advisory committees that have historically been used to help create clinically sound policy. So the result has been that the max are issuing bad and they have very, very wide reaching negative implications, including issues with the lack or diminishing access that we're seeing in the LCD and LCA that you mentioned, Brian, that were issued by CGS First Coast and Novitas for the cellular and tissue-based products for skin wounds or CTPs. And we're extremely concerned that the MACs didn't engage stakeholders in the crafting of the policies, but they're also not following certain procedures and regulations that they're required to follow. So advocacy becomes a very large issue here so that patient care isn't impacted, which we believe it will be. And I think Kara can probably touch on some of those and we can even get into some of the specific policy issues when after Kara has discussed that.

Kara Couch, MS, CRNP, CWCN-AP, FAAWC:
Yeah, I think that it's a huge issue not just for the clinicians, but more so for the patients because they are essentially having to disrupt their current active treatment plan, which was probably working for them with no recourse and no alternative. And the language is so severe and that we cannot make appeals for patients who were doing well with the product. It's just absurd to cut people off from nine applications to four and give us less than six weeks’ notice. We can't even regroup fast enough. So what's going to happen are negative unintended consequences for the patients who unfortunately will bear the brunt of this by getting amputations, which will then lead to depth. So a cost saving measure or an attempt to maybe reign some areas in is really going to backfire and spiral and add to the cost burden for CMS and also make our patients' lives much more miserable, which is just, it's absolutely ridiculous what they're doing.

Karen Ravitz, JD:
It is. And to that point, Kara, it might be good for the listeners to know sort of what some of these provisions are that we're referring to. So in these LCDs that CGS and Novitas and First Coast have issued, what they've basically done is they said, you know what? The number of applications that you're permitted to use for a patient in a 12-week period of time is now limited to four. And there are no exceptions according to them. At least in the policy it says there's no exceptions. We are trying to gain clarification to say, well, wait a minute, how can you say no exceptions? Right? I mean, that's kind of a crazy thing because there are some patients that will be moving towards wound healing, they're going to be progressing and after four applications, they're cut off. Well, they're going to completely regress and or get an amputation or even more seriously death because you weren't able to the progression of wound healing.
 
So that is hugely problematic in terms of the number applications. And there isn't currently either a grandfathering clause in the policy that will allow a patient that's currently being treated based on a plan of care that was established prior to September 17th, which is the implementation date of these LCDs. There's nothing that allows them to continue their care. So not only moving forward is the four application limitation a problem, but it's also a problem for patients who are currently receiving care that comes September 17th, their care is going to be disrupted, so there's no grandfathering clause allowing them to continue their care. And then another really big issue is that the max decided to remove a whole lot of products that are currently covered. I think there's maybe over 140 products that have been moved from the covered list to the non-covered list. And by removing these products and placing them in a non-covered list, the max are making coverage decisions that, and in doing so, they're required to provide evidence to support their decision in moving them from covered to non-covered, which they have not done.
 
And this is, again, very problematic because if you are using a product currently that is going to be moved to the non-covered list again come September 17th, you can't use it. So that's going to disrupt care for current patients. But then you also have issues with maybe facilities who have a formulary who have products on the formulary that are now they have to figure out what products they want to put on the formulary, and there's a process for that that takes significantly longer than just the six weeks that they've given us for implementation. So not only is CMS not following their own guidance and placing products and following the process for covered versus non-covered and providing evidence to support their decision, but it's also providing a lot of confusion in the clinical community because they're not being very consistent in what they're putting on the group to covered list versus the group three non-covered list.
 
So for example, right now, the way that Medicare regulations are written, and this is not our issue, this is the way that Medicare regulations are issued. Only sheet products are covered. So any product that is not in sheet form is currently not covered. And yet the covered list on these LCDs contain some products that are not in sheet form. So that's going to be confusing to clinicians who are looking to think that they're covered when in reality they're not. And then they might be getting an overpayment determination or some sort of post-payment audit and they might have to recoup, the Medicare program will recoup the money that was put out for those products. So that's a problem. And then on top of that, then there's also products that are on the non-covered list that have followed all the requirements that are put forward in the LCA and they've provided the necessary documentation and they're also in sheet form, and yet they're still on the non-covered list. So it's very confusing to figure out as a provider, I'm sure Kara, what products you can and can't use based on this list because it's not consistent and they can change that at any time because it's issued in a local coverage article. So products can shift from covered to non-covered and non-covered to covered at the whim of the contractor. So that's a huge problem as well.

Kara Couch, MS, CRNP, CWCN-AP, FAAWC:
Yeah, I think that it's incredibly difficult because you can't keep up, and again, this all takes a lot of time. It takes weeks and months to get products through your formulary and get them added in, and then you have to address the charge masters and things like that. And so by giving us six weeks from notice to implementation, it's just absolutely, absolutely absurd. In addition to just the logistics part of it, starting this in the middle of the year when traditionally we're used to starting new policies and things like this at the first of the year because you reset the clock, so to speak. So clinicians have been used to resetting the clock yearly for these CTPs for over a decade. And by switching it up now and resetting the clock nine months into the year, it's a huge problem for these patients because we know that a lot of venous leg ulcer and diabetic foot ulcer patients have recurrences.
 
So if we had a wound earlier this year and it healed and we use the CTP, that's fine. And then come in with a new wound. Now at the end of the year before we could have put a different product on if it was a diabetic foot once and then a venous leg ulcer ulcer, you could start a new series, but now you can't do that anymore. And it's a really, really confusing issue. And your point about the local coverage article switching products around, there are products that are the same product, but different sizes on the covered and the non-covered list, and it has to do with the sizing of all of it. And so it just really doesn't make a whole lot of sense that the smallest sizes are the cheapest and a lot of those are the ones that are now no longer covered. So why am I going to pay more money for a product that I don't need and I'll be wasting, whereas I could have chosen an appropriate size for the wound that I had there. It's just really incredibly frustrating.

Karen Ravitz, JD:
Yeah, and to your point too, Kara, I mean there's also some policy language that not only is either new, but that we also don't agree with, to your point. So they are now saying in the LCD that HTPs or anything that is a wound covering, which most HTPs are considered wound coverings because of how they go through the FDA, those products are non-covered according to the policy. So that's a little bit confusing because their rationale is that these cellular products are supposed to adhere or affix to the wound and wound coverings don't do that. They're more like surgical dressings, which is clinically and technologically inaccurate. And so that's a huge problem. And they're also calling these products rather than in an advanced therapy, which is what they are. They are calling them wound management products. And that's hugely problematic because first of all, we've never seen that language in any draft form for this policy.
 
We've never seen it. They put it in the final, but they never gave the opportunity to provide any comments on it. But secondly, CMS, when they issued the physician fee schedule last year, wanted to change the nomenclature for CTPs, and they put it out in notice and comment, and they called them wound management products. And through a lot of commenting, including from the AMA and the Health Information Management Association along with every single clinical association under the sun, everybody said, no, it's not appropriate to change the terminology for CTPs to that nomenclature. And yet here we are, the three max decided in this policy to call these products. I'm sorry, they called the Moon Management Methods. And again, they didn't afford anybody the opportunity to provide any comments. And CMS has already dismissed it as a nomenclature for these products.
 
So why it's showing up in an LCD is kind of odd and sort of goes against all the regulatory requirements that we know. So that's also a problem. And then you have the whole issue of retreatment of a wound. So if you have a wound that you've already treated on your foot, the way that the coating works, there's really no distinction that you're treating a different wound. You're just showing that you're treating a wound, let's say, on your left foot. And so it's going to be very difficult for the MAC to that. In fact, it's going to be a new wound that you're tweeting on your foot as opposed to one that maybe you only use those four applications under this policy and already healed. So they don't address that at all in this policy. And that's also hugely problematic to providers who, for all their intentions are following the policy, but because of the way these products are coded or how the claims are being submitted, there's no distinction that it's actually a new wound that's being treated. That's another problem that we are really trying to address, and this is where advocacy is hugely, hugely important. The alliance has moved forward with a call to action, and we have also submitted a list of frequently asked questions to all of the max that we are waiting to receive feedback on, but it's really important for clinicians and their patients to send in letters of concern to the max because again, we're trying to avoid disruption of care and we're also trying to avoid bad policy being implemented.

Marcia Nusgart, RPh:
Well, what's interesting is that the Max really do listen to clinicians and obviously Medicare beneficiaries, so that's why it's so important. But let's just talk about a little bit about where if clinicians do live in a certain area, they're the ones that are going to be impacted by this. So there's three different MACs Karen had mentioned. One was Novitas, one was CGS, and one was First Coast. So the states that Novitas covers are Arkansas, Colorado, Delaware, Louisiana, several counties in Maryland, Mississippi, New Jersey, New Mexico, and Oklahoma, Pennsylvania, Texas, several counties in Virginia and Washington, DC. Those in the CGS area includes both Kentucky and Ohio. And for First coast, we're addressing Florida, Puerto Rico and the US Virgin Islands. So our website also does have a map to see this list and the, as well as Karen mentioned, the specific policies of each one of these Macs, as well as our call to action and sample letters that you would be able to send, both you and your patients would be able to send to these Macs.

Brian McCurdy:
So if you are in one of these states and you share the Alliance concerns, what can you do as a provider?

Marcia Nusgart, RPh:
I would say the first thing that one can do is to the Alliance website. There will be instructions on how to make your voice heard. There are sample letters for both you as a clinician as well as to be able to give to your patients to be able to submit to the MAC medical directors, which is extremely important that they hear from you because the more letters that they hear, the more questions that are asked, that will certainly be an impetus for them to be able to take action.

Karen Ravitz, JD:
But you also just need to keep in mind too that these policies will go into effect on September 17th. So time is of the essence. So I urge anybody who is wanting to be involved and send something in to do so by September 8th because that'll give the max time to review these things. And I would also urge the listeners try not to do a form letter. This is something that you all practice. You do wound care your patients, and you know that any interruptions in their care is going to be hugely problematic. So make it personal because if the letter all come in as a form looking letter, it's going to be counted as one. It's not going to be looked at as this massive amount of concern. So I will say that. And then I would also say that just in terms of managing expectations, so there are certain issues that can be addressed by the listeners and certain things that are a little bit more of a longer term solution.
 
We are trying very hard right now to delay implementation so that care is not disrupted. That is something that you absolutely can impact. Absolutely. The issue of, I don't really like that there are four application limitations in the policy is going to be a lot harder to impact in these letters because that issue was put out in proposed rulemaking and they allowed stakeholders to provide feedback and comments. They didn't listen to us, but they allowed for it. And so as a result, in order to get something like that turned around, we do have to file something called a reconsideration request that is a longer term solution and it's something we are going to embark on. But what that entails then is gathering more evidence, new evidence, and submitting it in for their reconsideration to turn around that for application limitation. So that is something we're doing, but I just want the listeners to understand that right now, the most important thing we can do and you can do for your patients is try to delay the implementation of these LCDs so that you can not only continue to provide care, but it gives you ample time as Kara had mentioned, to make formulary changes if necessary and things like that.
 
So that's just my feedback to everybody, and I really do hope that anybody who's listening, I urge you to be involved for your patients.

Kara Couch, MS, CRNP, CWCN-AP, FAAWC:
I think another key thing is that we can marshal our patients and have them also respond to this because ultimately they are the ones that are going to pay the price of these LCDs getting implemented. So talk to your patients about it. You can come up with very easy information that you can hand them a one pager, provide them with the email addresses of the administrators, of the medical directors of these MACs. All of that information is on the Alliance website, and you can get it to the patients. And I know that we don't all have dozens and dozens of patients who maybe are email savvy with that, but you have three or four. And if all of us have three or four patients who then submit something to their max and about this LCD, we will make an impact, but we have to do it now. So not only do I really encourage us to engage our patients, also engage your other specialty societies, which you may be a member of. I know that I belong to a half dozen societies who are going to be affected by this, and so it's really important to make sure that they all also have the information and they can send it out to their members because we really need to blast this horn loud.

Brian McCurdy:
If you do want to get involved, remember to visit the Alliance's Advocacy Action Center and send emails to your MAC by September 8th, so policymakers have time to consider your request. Thank you all so much for sharing your thoughts and experience with the audience. For more podcast episodes, be sure to check out todayswoundclinic.com, SoundCloud, or your favorite podcast platforms.