Wound Care and Skin Substitutes Carrier Advisory Committee (CAC) Meeting - April 28, 2020 - JE Part A

LINDA MEYER
...Noridian facilitators, and also the Specialty CAC Members are in a listen only mode for the duration of this meeting. Please note that the meeting will be recorded, and a transcript will be posted along with the recording on the NoridianMedicare.com website. Records for this meeting and all of our CAC Meetings can be found out on the Contractor Advisory Committee page located under the Local Coverage Determination section on our website. Our Contractor Medical Director, Dr. Larry Clark, will lead the discussion with the Specialty CAC Members on the topics of Wound Care and Skin Substitutes. He will start with introductions and an overview of our CAC process, and then proceed into those specialty topic discussions, which will be a majority of our today's meeting. After the specialty topic discussion, we will ask the CAC Members a series of key questions. Each of the CAC Members will provide a rating of the level of confidence he or she has related to the evidence supporting each key question. Those ratings will be collected and presented for each key question during our presentation. Dr. Clark will then continue any additional topic discussions and conclude our meeting with the next steps in our policy development process. With that, I will turn the meeting portion over to Dr Larry Clark.

DR. LARRY CLARK
Thanks, Linda. Basically, the first thing I want to say, and I promised I would do this in three minute (inaudible). For many of our panelists and for our attendees, this is their first experience with the 21st Century Policy Development and Carrier Advisory Process. This process is different. I think the major thing that most Medical Directors agreed they had to get their heads around was the fact that we are not showing up with a policy tonight. In the Carrier, the new 21st Century Mandated Process we actually are weighing the evidence tonight, we are discussing the evidentiary basis upon which we will develop the policy. And perhaps in a little segue into Salesian Spirituality, what we are doing is we are focusing our intention. What we are trying to do is to see what is important to experts in the field to weigh the evidence that is the underpinning of those directions. And the policy will subsequently be developed by my colleagues and I over the next two months. We will then take that policy, post it on our website. It will also be posted on the CMS website, and we'll give all interested parties at least several weeks to observe and note the policy. We are then going to have two separate Open Meetings: one on the broad topics of wound care that we will be directing tonight, and one on the use of synthetic skin substitutes and more complex wound healing. These Open Meetings are open to the public. You will not be muted as you will tonight, people can sign-up to participate. That can be a patient; that can be a practitioner; that can be a stakeholder. It is an Open Meeting. We anticipate those meetings will continue longer than tonight's meeting. Following that, there will be a 45-day period of comment where written commentary will be additionally accepted, and then reviewed, and then a final policy will be posted.

I'm really pleased to say that the eleven individuals who have signed up to be panelists for tonight are going to stay with the process and help advise us in the development of the policy. That is why this is being recorded; that is why their conflict of interest statements have been filed; and they will give a brief overview of those conflicts before speaking tonight, along with their names. You only have, panelists, you only need to give the conflict of interest in a couple of sentences. But you need to say it the first time you speak, and then the next time you speak in the next couple of hours please just say your name first so we can identify you when listening to the recording. That's basically the process in a nutshell, and I did it, it's 5:08, so I did it in three minutes.

I'm going to introduce the panelists. I think you will agree that these are an extraordinarily distinguished group of people. I'm going to do them in alphabetical order. Dr. James Alexander is a General Surgeon, retired Naval Officer, former Medical Director Trailblazer Medicare. Dr. Joel Aronowitz is an Attending Physician, Department of Plastics and Reconstructive Surgery, Cedars Sinai Medical Center. Kara Couch is a Certified Nurse Practitioner and Nursing Director of the Limb Preservation Center at George Washington University. Caroline Fife is Director of Wound Care at St. Luke's Hospital, Woodland, Texas, and I believe she is the current President of the Wound Care Stakeholders, the Alliance of Wound Care Stakeholders. Got it right, Caroline?

CAROLINE FIFE
I was muted. It's Co-Chair. Thanks.

DR. LARRY CLARK
Dr. Grossman. Co-Chair, thank you. Dr. Peter Grossman is a Plastic and Reconstructive Surgeon. He is the Medical Director of three burn centers in greater Los Angeles metropolitan area. Dr. Dan Keating is a Podiatrist. He is a partner in Excelsior Orthopedics, and is currently the New York State, President of the New York State Podiatric Medical Association. Dr. Martin Johnson, also background in plastic and reconstructive surgery, is Wound Care Director at the Mayo Clinic in Scottsdale, Arizona. Dr. Dennis Orgill is Professor of Surgery at Harvard, Director of the Wound Care Center at the Brigham and Women's Hospital. Dr. Alejandro Perez, background is in vascular medicine, he is Director of the Wound Care Center, Providence Healthcare System, Portland, Oregon. Bill Tettelbach, William Tettelbach, background is infectious disease. He is Director of Wound Care for the Intermountain Healthcare System based in Utah. And Stephanie Woelfel is a Professor of Physical Therapy and Kinesiology at The University of Southern California.

So again, a brief reminder, the first time each of you speaks just give your name, one sentence if you want about yourself, one or two sentences of your conflicts of interest, and proceed. The first thing I would like to ask about these are the general questions, and then between hours one and two we will do that Key Question Analysis. So, Linda, if you would be ready in about 50 minutes on that.

The first question I would like to ask is, and I do also want to thank the folks at Noridian, particularly Novitas. Dr. Lalla, did the most recent original Medicare work in wound care about three years ago, with a policy which we are certainly not seeking to replace but seeking to advance. And in that time I have not seen a whole lot of change in what is considered to be the standard of care in terms of basic wound healing, wound moisture control, wound infection control, selective and nonselective debridement, etc. I'd like to ask each of the panelists if they would just kind of recapitulate the last three or four years, have you seen anything of change in concepts of biofilm, matrix metalloprotein? Is there anything else that you have seen that should be included in this policy that might better orient or make the care of the patient more appropriate and more effective? And since he was particularly sort of outspoken with his opinions and I found him to be a challenging speaker I am going to go to Dr. Marty Johnson from Scottsdale, Arizona. Marty, do you want to start us off?

MARTIN JOHNSON, MD
I'll be happy to. Can you hear me?

DR. LARRY CLARK
Yes. The question that I just asked you, have you seen anything new, anything beyond the basic six or seven areas of standard of care that you have seen in the past three years that you would add into the development of this policy?

MARTIN JOHNSON, MD
You know, probably, you know, when we were looking at new materials to replace our current, for instance, wound cleanser I did some research and started looking at hypochlorous acid as an alternative to the bleach solutions. And I, I found it interesting that, you know, there is evidence from both industry as well as in the literature to suggest that, you know, you've got a product that is 70 to 80 times more biocidal than bleach. And, you know, at the Mayo Clinic for me to consider something like this I've got to go the Surgical Supply Committee, and I have to show them what this product alternative could be. I'm going to be replacing a product, and I have to show evidence. I have to show, you know, what are potential outcomes. Is it safe? Is it cost effective? And so we've been playing with that. I shouldn't use the word playing, but we've been trialing that for 2020. And at this point are ready to make a recommendation to the Committee that we should replace that. It seems to be very effective against biofilm. It is a biocidal for both bacteria, viruses, fungi, and so anyway that's kind of our, our approach to biofilm and MMPs.

DR. LARRY CLARK
Thank you. Let me, anything else? I'm sorry, someone else jump in? All right, Jim Alexander, anything new?

JAMES ALEXANDER, MD
Okay, Larry. Can you guys hear me?

DR. LARRY CLARK
Sure can. Jim, go ahead.

JAMES ALEXANDER, MD
Okay, am I on now?

DR. LARRY CLARK
You sure are.

JAMES ALEXANDER, MD
Okay, good. I was supposed to list my conflict of interest. The main conflict of interest I guess for this group is to know is that I am a previous Medicare Contractor Medical Director for, and worked with Larry in Trailblazer, for a number of years ago. And that can be a conflict of interest, or it just might be just a body of knowledge. But anyway, I wanted to pass that on. My clinical background is in general surgery and I'm Board Certified and recertified and have tried to keep up in all of the relevant fields where my certification and certainly I've recently done some things on, in my CME that I do on wound care. I really don't, in the last three years and also looking at the information that I looked over, the scientific information that Larry was so kind to send, I really didn't see anything from my standpoint that I think there was anything much of a change. Certainly, biofilm is more on the horizon now than it used to be, and the understanding of that is it's better, I think. But I don't really think it's really changed that much in the last three years.

DR. LARRY CLARK
Thank you, Jim. Anything else?

JAMES ALEXANDER, MD.
I think that's got it.

DR. LARRY CLARK
Okay. Caroline, I want to get your reaction? Caroline Fife.

UNIDENTIFIED CAC MEMBER
Larry, can you guys hear me?

DR. LARRY CLARK
I have been trying to attend some of the wound care lectures. They are generally proprietarily sponsored and I've signed up for some of them. And I've actually learned that there are some technologies out there involving tissue biopsy, involving quantitative assessments such as wound blotting. What is the status of this, and is it really clinically relevant enough to be put in this policy? Gary, why don't you pick up the question? I’m going to dial in again and try and lose the feedback.

DR. GARY OAKES
Okay, okay, let me get back in here. I'm wondering if everyone that's speaking is mute?

LINDA MEYER
This is Linda. Yeah, we are all having that feedback. So please continue, Gary.

DR. GARY OAKES
Well - nope, no feedback there. Joel, are you there? Dr. Aronowitz? Maybe you are on mute. Okay, well I don't hear any, maybe having a little bit of technical difficulty there. So, let's move on down the line to Dr. Dan Keating. Dan, are you available for us?

DANIEL KEATING, DPM
Yes, I am here, thank you. I have no conflicts, but I am still the CAC Rep for New York State. And in terms of biofilm, I don't see anything that's really new yet. I still think that good, clean, adequate debridement gets rid of the biofilm, so I don't see any, anything topical that's brand new that I've been using. Thank you.

DR. GARY OAKES
Thank you, sir, appreciate that. Dr. Aronowitz, have you been able to get us back?

JOEL ARONOWITZ, MD
Yes, can you hear me?

DR. GARY OAKES
I can now, thank you.

JOEL ARONOWITZ, MD
Oh okay, great. So, my name is Joel Aronowitz, I'm a plastic and reconstructive surgeon in Los Angeles at Cedars Sinai. I don't have any conflicts of interest. I have a busy wound care practice, and experience over the last 30 years with reconstructive surgery and this topic. So my answer to Larry's question briefly is that what's new in the last few years is I think we have, I think we have a consensus that we can already hear revolving around the basics of wound care that are well accepted. I think that on the horizon is the use of autologous and both autologous and other human stem cells obtained from umbilical cord and umbilical cord blood and even cultured. They are still in an experimental phase at this point; however, and not well accepted, I think the other thing that's on the horizon for all wound care practices is going to be the issue of viral transmission of the COVID virus in wound care detritus and bodily fluids that we are going to have to contend with in everyday practice. So that's my two comments regarding Larry's question.

DR. GARY OAKES
Super. Thank you for that. I guess I’m just going to keep it simple.

DR. LARRY CLARK
Well, I'm back. Can you hear me?

DR. GARY OAKES
No, we can't hear you. Go ahead.

DR. LARRY CLARK
Was that Joel last talking?

DR. GARY OAKES
Yes, that was. Yes.

DR. LARRY CLARK
Good, thank you. Gary, did you have a question you were going to ask?

DR. GARY OAKES
No. I was just going to say, I was going straight down the line, so Kara.

DR. LARRY CLARK
Go ahead.

DR. GARY OAKES
Kara, are you available?

KARA COUCH, CRNP
Yes, I should be. I'm muted now. Thank you. I am a Nurse Practitioner and Wound Specialist at GW Hospital in DC. I do both inpatient and outpatient. I have a few disclosures of doing some consulting work with various industry partners. I also am on the Board of the Association for the Advancement of Wound Care, and the Alliance of Wound Care Stakeholders. I'm also the Chair of the Scientific and Medical Advisory Committee for the Amputee Coalition. So those are my main disclosures. I am also an Assistant Professor of surgery at GWU School of Medicine. So, I've been doing this for 17 years, and I had this discussion with Larry last week. I think a lot of what we can use to kind of frame our thoughts are with the guidelines that have been published in the past couple of years. For example the NPIAP put out new guidelines, and even if we are looking at wounds more specifically how do we incorporate things like the Society of Vascular Surgery's Wound Ischemia and Foot Infection Classification System? And making sure that when we consider developing a guideline for wound care that we are looking at things like making sure that the patients get appropriate vascular testing early, that they don't wait three, six, nine months before they get a venous ultrasound for a venous ulcer, or arterial noninvasive for arterial insufficiency in diabetic foot, etc. So, I think that is something I would encourage us to look at in addition to examining the evidence, looking at the guidelines and the various classification systems, how we weave those in.

DR. LARRY CLARK
Thanks, Kara. Your reference brought something into my mind. There is a group that I believe the only two US Representatives are, there is a Dr. Driver from Brown University and Dr. Attinger from Georgetown. It's an international workgroup on the diabetic foot, and they renewed their guidelines. I think that was one of the things that Jennifer Van Pelt, our Research Analyst sent out in that packet to you. What I seem to be impressed with on some of these seminars that I have signed up for, again, talking about actual biopsies from the wound, the use of RNA transcriptase I think they call it, transcriptomic analysis of wounds, the concept I mentioned of wound blotting. And yet this international and seemingly highly thought of group is very, very conservative. I was just going to ask Kara in her conclusion, are any of these things being used at George Washington in anything beyond a research capacity?

KARA COUCH, CRNP
Not at GW right now. It's possible that Georgetown, that's where Chris Attinger is, is using that. I know he has a robust research platform, but we haven't gotten that down to GW quite yet, aside from research.

DR. LARRY CLARK
Well I mean I'm wondering. I think I'm going to jump ahead a little bit out of order here to Dr. Dennis Orgill. Are you using any of these technologies at Brigham and Women's? Do any of them have any substance or consideration in the present environment?

DENNIS ORGILL, MD
Can you hear me, Larry? We use a lot of -

DR. LARRY CLARK
I can, and just give a thumbnail of the conflicts of interest with the research you are doing.

DENNIS ORGILL, MD
Integra, I consult for Integra Life Sciences. I receive research funding from TCI, from E-Cell. I work with clinical trials, with a group called Perry that does a lot of clinical trials on diabetic foot ulcers. And I've been involved in the development and technology transfer of many other products over the years. So yeah, there is a lot going on out there in the world of biofilm and wounds. And it's a little hard to know where things are going because the literature, as you point out, is not crystal clear. But I think this group was going to focus on skin substitutes and when we should be using those, and what kind of evidence would be optimal to, to provide to practitioners so that we can give them good choices but not overuse them if we don't think we need to. So I think it's a really broad topic and it's hard to go - the issue of biofilm is everybody thinks it's there but we don't have really a great way of measuring it and/or reproducibly finding out if we are making a difference. So, there is a lot of technologies that show promise, but you know, I don't think we've hit the magic thing yet for biofilm, and there is still a lot of work to do. So, I think I'll stop there.

DR. LARRY CLARK
Thanks, Dennis. And in terms of that concept of transcriptomic analysis, again, potential of value in the future but not in the present?

DENNIS ORGILL, MD
I mean I think at the end of the day we need to do, we need to do some large prospective study showing that, you know, that you use that information in a way that makes a difference to the patient and the outcome, and that you reduce amputation rates, or you get people with a wound to heal quicker or something to add value to the system. Just because it works in the laboratory doesn't necessarily translate into improving the human condition.

DR. LARRY CLARK
Thanks, Dennis. I am going to skip again to Stephanie Woelfel, understanding that her constituent group of physical therapists are involved in active wound debridement and care. Stephanie, anything that you would add to the standard of care as defined in the predecessor Novitas policy? Anything that has changed in the past three years? Anything you are doing different at USC?

STEPHANIE WOELFEL, PT
I think, you know, I would, oh sorry, Stephanie Woelfel, PT, University of Southern California. No conflicts. I would concur with my colleague that mentioned the use of like some of the hypochlorous cleaning agents. That's something that we've converted to at USC recently as well. I mean I think we are; we are still in the beginning stages but looking at some of the fluorescence imaging in relation to identifying biofilm. But that hasn't really changed anything from a standard of care perspective as how we would potentially treat those patients. It's just helping us potentially identify them more quickly or, you know, kind of target the care a little bit. So, I would say from the standard of care perspective I think things are fairly similar at this point.

DR. LARRY CLARK
Thank you. Dr. Peter Grossman, joined us too, to give the added perspective, not that we are going to focus on burn care in, really in the context, the general thrust of this policy will be the same as the Novitas policy in terms of DFUs, VLUs. But Kara Couch did ask us if we would include, try to be inclusive of some of the other wound types that affect the senior population, and we will try to do this. But I did want to, while we are talking about basic wound care, I would like to hear Dr. Grossman if he was doing anything different, changing anything from the standard of care? Peter? Hello? Are you on mute, Peter? Hello?

DR. GARY OAKES
Yep, still hear you, Larry. Don't hear him

DR. LARRY CLARK
Okay, so I'm going to ask -

LINDA MEYER
Dr. Clark, if I could interject. Dr. Grossman, if you happen to be on your cell phone if you could type in the presenter chat, the last four digits of your cell phone number. It may be that your cell phone is not in a presenter mode.

DR. LARRY CLARK
Thank you.

LINDA MEYER
We'll try to work that out because we do know he's on.

DR. LARRY CLARK
Okay, thank you.

PETER GROSSMAN, MD
Can you hear me now?

DR. LARRY CLARK
Yes, we can.

PETER GROSSMAN, MD
Oh, I'm sorry. So, I'm Peter Grossman, and I'm a plastic surgeon with a focus on care of the burn injured patient, both in the acute and reconstructive format. No conflicts but in disclosure, I am on a Board of Advisors who are at a company called Xircom, which is a company that makes new type of dermatome. You know, there is a lot of crossover now in acute burn wound centers, they do both burn and wounds. And so, there is some crossover, and about a third of our patient population is elderly. So, using skin substitutes becomes something that is of significant interest to us in the burn realm. We are somewhat limited in the acute care and what options are available to us based on reimbursement, which is a real factor. If the hospitals don't get reimbursed, then they don't allow us to utilize some of these skin substitutes. So, it's an interesting dilemma that we have. From a bioburden still the basic care for burn patients and other types of wounds that burn centers take care of is a mechanical debridement, occasionally enzymatic debridement. And I do think that in many cases that deals with the bioburden, although for some of the more extensive burns that take months to heal you do get a biofilm burden. And we are stressed in how we deal with that, and so hearing what some of the others here in this conference are utilizing would have some important crossover benefit for us.

DR. LARRY CLARK
Thank you. What did you have in mind, Peter, in terms of the benefits?

PETER GROSSMAN, MD
Well, you know, one of the things that we tend to find is that for patients who have had extensive burn injuries who do not have enough of their autologous tissue to graft and have long term open wounds getting them epithelialized becomes harder and harder the longer that the wounds are exposed. I do believe that bioburden, very similar to chronic wounds in diabetic foot ulcers or chronic venous stasis wounds or chronic arterial ulcers, is similar. And so, I would like to find out what is considered the up and coming modalities to treat the bioburdens that may end up being beneficial for both us in burn as well as in more the chronic wound market.

DR. LARRY CLARK
Anybody able to help Dr. Grossman out with suggestions or things, even if it's not necessarily within the purview of this policy. Is there anything out there in answer to his question? Because it seems to me that this is where the chatter is, I just don't see it being thoughtfully endorsed yet and probably not ready. Is there anything that's really on the horizon here? If anybody has an answer just un-mute and go right ahead.

JOEL ARONOWITZ, MD
I think that the use of - this is Joel Aronowitz. I think that the use of autologous and neonatal stem cells is really what's been on the horizon for the last 10 years and has been - and development has been held back by the FDA Cyber Division. The use of cellular and human tissue product has really - their classification of these cells as thwarted research basically. But that's what in my opinion is really on the horizon. I do think that a policy change could help people like Peter out a lot and myself, plastic surgeons who deal with wounds all over would be able to use skin substitutes more freely if we weren't constrained by the same LCDs that are designed for lower extremity wounds in particular. So, I think we should accept the principle that wounds are wounds wherever they are anatomically, they shouldn't be defined anatomically. And that some of the side constraints or the constraints with how much you can use on a, you know, at a particular time we should reconsider for special circumstances, for example like Peter's where he's dealing with larger burns.

DR. LARRY CLARK
So, so your proposal in terms of unique situations is the presentation of the patient with the largest surface area wounds?

JOEL ARONOWITZ, MD
Yeah. And the basic concept that we shouldn't categorize wounds by their anatomic location, we should consider a wound a wound. It's just we have venous stasis ulcers on the ankle because that's where [inaudible] venous stasis, but the wound is a wound wherever it is. So for example, a study that demonstrates efficacy of a diabetic foot ulcer or a venous stasis ulcer it, that study should be applicable to other wounds in other locations, not specific to the fact that the original wound was caused by venous stasis, for example.

DR. LARRY CLARK
I'm trying to think about that in the context. It may have to be outside the context of this policy. I am going to just take a brief minute here in terms of, again, focusing what you need to advise us on over the next few months as we go ahead in this policy. And then there was a place where you and Dr. Keating were surprisingly in alignment, although coming from different specialties. And we may head off into a slightly different direction. But I do want to say that what prompted Dr. Oakes and I to head off in the direction of a jurisdictional policy, this is not - you know, many of the policies these days are coming as a collaborative initiative from multiple MACs. This one, while we are certainly offering it to any of our fellow AB MACs is coming to solve problems within our own Noridian jurisdictions. We are seeing, despite educational efforts, despite sharing tenets from some of the other contractors' policies in terms of education within our jurisdictions, we are still seeing disorganized, protracted, ineffectual wound care, with the biggest circumstance not the dollars but the poor care of the patient. We are seeing patients who are far too long in the course of treatment of the patient before there is any attention to vascularity, and that's something that Dr. Perez is going to open the discussion on in a couple of minutes. But we are also seeing, you know we come to the end of a course of one particular, one episode of treatment and we go right into another one with no change in the medical management of the patient. So, part of our effort is we have to try and focus on better, more thoughtful care within our jurisdictions. So, so far, I have not heard any deviation from what is considered a standard of care. Let me just open it up for a few minutes here, and any suggestions to us in terms of policy directed improvement in wound care?

CAROLINE FIFE, MD
Dr. Clark, this is Caroline Fife.

DR. LARRY CLARK
Just un-mute. Go ahead.

CAROLINE FIFE, MD
This is Caroline Fife. So I don't think that there have been - my disclosures are the Co-Chair of the Alliance of Wound Care Stakeholders and the Directorship of the Quality Reporting Registry that works with the Alliance, the U.S. Wound Registry, and I'm on the faculty at Baylor College of Medicine in the Geriatrics Department. I haven't seen any game-changing technologies in the past three years that would affect our definition of the standard of care. There are many new things on the horizon. I believe you began the conversation about whether there was a change in the standard and I don't think that's the case. I think there is a recognition that we have done a poor job with things like nutritional support and the impact of low Vitamin D level in collagen production, so that may be an example of an old thing that's new again that has been poorly represented. So, I think also the only game-changing thing that I have seen is platelet-rich plasma, autologous platelet-rich plasma, the reimbursement for which is not clearly established yet; but I think the standard of care is well understood now.

DR. GARY OAKES
Well Caroline, help us understand what's the best way to use this policy as a textbook to educate physicians and nurse practitioners how to apply the standard of care because that's our biggest challenge.

CAROLINE FIFE, MD
Yeah, that I could have, you know, I could have asked you to ask me that question because that's where I think quality reporting and quality measures fit, because the guidelines tell us what kinds of practices are accepted and appropriate. And quality reporting, or quality measures, gets to the implementation of it. Which is why the registry crafted a series of quality measures to implement those guidelines, such as arterial screening on the first visit, and evidence based and appropriate compression of venous ulcers at each visit; offloading of diabetic foot ulcers there are a number of them, and none of them are rocket science. They are implementing in a very basic way and measuring the implementation of the guidelines, so I think that's the place to start.

DR. GARY OAKES
Yeah, the unfortunate part of that is we as a contractor cannot require participation of registry for a study; but I'm trying to think how to best phrase this. Each of you are doing a great job, no question about it. So, we may need to use your expertise and your guidance to bring this out to the masses who are treating these day by day. That's, that's one of our biggest challenges is just getting out there as you and I have talked, and as I've talked with Larry and Marsha, my main goal here is to take care of the patient, save as many amputations as we can, get them back on their feet, get them mobile. And, you know, this diabetes thing, the bad disease it is, we still need to work with it and keep it under control. And that's the biggest challenge that we've got. But it's nice to know that what we've done in the past hasn't gone in vain, we are still preaching good stuff.

CAROLINE FIFE, MD
Thank you - it's Caroline, I think you are correct that the basic things are the things we all need to begin with. And one possible use of some of these quality measures isn't that people are required to report them, but they are a way of framing guidelines. So, it's possible to use the framework of arterial screening at the first visit, for example, when Dr. Clark was mentioning that things languish, and they don't get done in a timely way. It's possible to at least use that framework to say this is the approach that helps implement those guidelines in a way that's best for the patient.

DR. GARY OAKES
Thank you, that's very helpful. And we may have to do it through chart reviews, which I hate doing, but at the same time it may come down to that for some folks that we see that are not being compliant. And perhaps maybe a way to do that is to have them bill for the vascular check in some way, form or fashion, or have a quality code that they put on there saying yeah, I did it this time. And those that don't have that -

Yeah, within a couple of visits at least we could go and say why aren't you doing this?

DR. LARRY CLARK
Yeah, those are great points, Caroline. I'm going to, you know, actually take advantage and segue again building off something that you said. Dr. Alejandro Perez, who is with us tonight from the Providence Healthcare System in Portland, came into wound care from a different direction, from that of vascular medicine. Dr. Perez, you gave me a kind of a thumbnail in a few minutes of evaluation, a complete vascular evaluation of the patient, arterial venous, small vessel, etc. Could you just recapitulate that right now?

ALEJANDRO PEREZ, MD
Sure. Can everyone hear me?

DR. LARRY CLARK
Yes, we can.

ALEJANDRO PEREZ, MD
So, to speak, first of all no disclosures, I am a vascular medicine specialist out of Portland, Oregon. So, to reiterate and to add onto the discussion, so limb wounds are different from wounds in other areas because the vasculature plays a much greater role in regards to healing. And so most hospitals that have some sort of vascular association, and I'm the Medical Director of ours, have implemented either through third party wound company or through internal protocols some sort of assessment early on in the patient's journey through wound clinic to assess for any impediments to wound healing due to arterial or venous supply. And that has important considerations as to what you would do, because you could have a long-standing diabetic foot wound and you could talk about what skin substitutes may be appropriate, but if there isn't enough circulation then you are not addressing the critical issue. If you have a venous ulcer and of course you need to do compression, but if there is an underlying venous disease that's not addressed potentially with intervention then again there is some stalling that would not have otherwise be there. So specifically, to talk about arterial disease the standard of care in most clinics is to do some sort of ABI. We all know that that's an important tool, but we also know that it can under-represent the degree of disease, specifically in diabetics, chronic kidney disease patients, older patients. And so, it's basically in the most workflows to get also some small vessel perfusion assessment in regard to diabetic foot wounds because you can have a normal ABI and still have significant arterial disease. And what used to be called small vessel, or (inaudible) was (inaudible) or diabetic disease may not have been addressing those, so the quality to address it wasn't sufficient. But now with endovascular strategies that can re-catalyze plantar wounds, that's no longer fair to say. And if you don't acknowledge that that is a concern, that that is an issue with a patient they could end up with amputations unnecessarily when in the past maybe there was not the technology to address it, and now when there is an aggressive evaluation of not only large vessel disease but small vessel disease we can sometimes prevent an amputation. So that's one change that we've been pushing for in the community. It’s already been occurring at our wound clinic, and we'll push for that in the community from an arterial side. From a venous side there has been data now to show that early intervention in regard to venous disease can promote healing faster, and maybe prevent recurrence. In the past venous interventions were reserved when patients had healed to prevent recurrence, but now we can show that if somebody has a venous intervention in addition to standard of care, compression therapy, dressings, a dressing infection, that you can actually shorten the timing of wound and the time to healing. And so, I would agree that every patient needs a vascular assessment if they have a limb wound because these issues did not address delayed wound healing. And so, for my proposal, in addition to what other people have already stated, would be yes, we all agree vascular assessment is important. But a further nuance of that would be a vascular assessment with an ABI or some other tool for large vessel disease with some small vessel assessment, whether that be a toe brachial index, the skin perfusion pressure, transcutaneous oxygen monitoring, something to know what else is going on below the level of the ankle. And of course, for venous disease, not ruling out UVT but an actual venous reflux study to assess if something can be done on that side. Because just like you would not put a skin substitute on the bottom of someone's wound that's not offloading you would not, you know, put a skin substitute on someone whose got an ischemic wound that hasn't been revascularized. And so those are kind of important points, and kind of more newer data than people have traditionally been following.

DR. LARRY CLARK
This is Larry. Let me just ask you a couple of questions. You mentioned the toe brachial index, I think that is becoming a more standard and accepted technology. You also mentioned small vessel perfusion studies. Are any of these getting to a level of acceptance that they should be included in a policy? Is there an evidentiary basis to underpin what you just said?

ALEJANDRO PEREZ, MD
I'm looking at one reference right now, Journal of Vascular Surgery, May 2016, Volume 63, Issue 5 that assessed how often arterial disease is missed if you only use an ABI to assess, and basically the value of assessing small vessel perfusion for limb salvage to prevent amputation. And as far as venous disease, allow me, this was published in the New England Journal 2018, 378:22, it was an investigation of a randomized endovenous ablation and venous ulceration. So, I mean so there is data out there. A lot of the guidelines have been out there for quite a while and maybe have not necessarily incorporated these specific numbers, but specifically if you have a normal ABI but an abnormal TBI that still warrants further vascular evaluation. If you have venous reflux that warrants a discussion with a vascular interventionalist, something (inaudible).

CAROLINE FIFE, MD
And Dr. Clark, this is Caroline Fife. A quality measure that -

DR. LARRY CLARK
Go ahead, Caroline.

CAROLINE FIFE, MD
The quality measure that CMS has approved through the wound registry is actually the assessment of healing potential. So while it's couched in terms of arterial assessment, it's actually focused on whether there is adequate perfusion to heal. And transcutaneous oximetry and skin perfusion pressure are the preferred measures, we just can't restrict it to that for quality purposes. And transcutaneous oximetry and skin perfusion pressure are very available in many wound centers, and I think most people would agree that they are far superior to ABIs or even TBIs. So, the focus on healability with the secondary question being if perfusion or oxygen is low is it because of a fixable arterial lesion? That seems to be the crux of the issue, and most of us on the call can recite almost weekly the patients who come to us after months of care somewhere else and ischemia has been missed because a more sensitive test hasn't been done. It's probably where you waste most of your money right now.

DR. LARRY CLARK
Thank you, that is an excellent point and I'm going to ask you, and actually I'm going to ask all 11 panelists if you would commit some of these thoughts and recommendations to writing, but I really appreciate that. There is one person that we've not heard from yet and I think that we are going to ask him to kind of summarize some of the frustrations he has had. I think comments that he made are the perfect segue into the second hour and where we will break to go through the key questions. And then we are going to open the session on synthetics, or skin substitutes, not just synthetic, with some remarks from Dr. Orgill. Let me ask Dr. Dan Keating, one of the things that he said which really struck me on behalf of (inaudible) and constituents in small group and individual practices is the difficulty in maintaining particular wound products in a smaller office. You know, I was sort of coming into this in a world where I was looking at, you know, 104 or something Q codes, and then Jim Alexander last night sent me a list of proprietary products that were viewed as investigational by commercials. I think that was 82 Q codes off the table right there. And so, Dan Keating was talking about the difficulty of maintaining in, even the ability to do clinical research in the smaller office because of the difficulty in maintaining consistency in the care of the patient. And it was interesting, Dr. Aronowitz from Cedar Sinai, a person who I would not have expected the exact same comment to come from because of the support of his medical faculty, and yet he made the same point. So, Dan, you want to go over some of those frustrations that you talked about with me?

DANIEL KEATING, DPM
Sure, Larry, thank you. Again, I have no conflicts. I am in private practice, and I think that I agree with so much of what everybody has said, and blood flow is so important. The challenges that we face in the private office settings are oftentimes multifactorial. One is offloading. We have an idea of what products are best of offload a patient, and oftentimes we write the prescription and we'll send them, and it's not covered. So, some type of standardization and consensus on the proper offloading, maybe contact cast is the standard but it's often not feasible with that extremely large patient that isn't compliant. Many of the wound care products, the same thing, the cost is difficult. And the skin substitutes also are also oftentimes not covered by many of the insurances that we all deal with. And I hope that somehow, we can add some of these things, even the non-diabetic PVD patients should be allowed to have some of these products that are sometimes rejected because they are not a diabetic. The key though to all of this oftentimes is blood flow and offloading, oftentimes I'll see a patient and they will be admitted to the hospital for another reason, and I will see them in the hospital or after they've been discharged and their wound is better. So, I know that offloading will work as long as the other parameters are included. But it is certainly challenging when so few products are often covered in the office, the skin care, the substitutes that are very expensive, you don't get paid a whole lot to apply the skin substitutes but the cost of these are oftentimes $1500 or more. And in the private office setting, you put three or four applications on in the office, sometimes the bill comes, and that money has already been used for payroll. So, I hope I'm not going on too long about this, but the cost really becomes an issue with trying to create a standard in your own office. So, I hope that answers the question, Larry.

DR. LARRY CLARK
Yeah, no, thank you, Dan. It was just, it was again another and different perspective, one that was a little bit more removed from, you know, the facility-based practice. But I thought it was a real one that many ways your choices are determined by what commercials and Medicare Advantage does because you can't keep everything in a small office, that that becomes financially impossible.

DANIEL KEATING, DPM
Yeah, it just gets too costly to keep so many products on the shelves. And oftentimes the shelf life doesn't allow you to do that.

DR. LARRY CLARK
Linda, are we ready to go on to the key questions?

WILLIAM TETTELBACH, MD
Hey, Larry, this is Bill Tettelbach.

DR. LARRY CLARK
Go ahead, while we are -

LINDA MEYER
I was going to say, Dr. Tettelbach is impatiently having his virtual hand up. So, we'll allow him to be able to put his hand down. So please go ahead.

DR. LARRY CLARK
Go ahead, Bill. And then you get, if you would get the key questions ready, Linda, that would be great. Thank you.

WILLIAM TETTELBACH, MD
Yeah, this is Bill Tettelbach. My conflict of interest is that I'm currently the Associate Chief Medical Officer for My Medics. I was the Executive Assistant Director over Intermountain Healthcare, which was 22 hospitals and 10 outpatient clinics for eight years until just about two years ago. I still actively practice. I'm the Medical Director over wound care and infectious diseases for Providence Hospital here in Salt Lake City. So, I wanted to state a couple of things, you know, in regards to the last three years or whatnot. So, you know, I totally agree with the hypochlorous statement, that is something that we initiated almost eight years ago and saw anecdotal differences in our outcomes, people, you know, going to the ED for post-debridement and cellulitis dropped off. One of the other things I think has been new, and we started this also about six years ago, and were fortuitous coming into the COVID-19 pandemic is really telehealth. That's been a game changer in a large system and multi-clinics in the sense that when you have large backlogs of patients and you have patients who don't necessarily have to come in every week, but you can follow. Or you have very complex patients who are vented at home, or are paraplegics, or have pressure ulcers and other reoccurring symptoms having telehealth and having been in a system that was supporting that really changed everything. And so, we were doing things, you know, for a penny a visit. Part of the problem is you have to use the resources of home care to be able to roll the patient, see where the wound is, get recommendations, guide them, the individual who is in the home on their scope of practice. And so, there was no real set reimbursement on that. It's unfortunate we've had to go through a pandemic to open up some of this, but I think once the pandemic is gone we have to reevaluate that we still need this outlet to manage this ever-expanding group of wound patients as the elderly population increases. One of the other things is also site of service. So, this has been a new thing with the less, you know, more patient, less paperwork and open access. You know, there have been very innovative folks out there in the last three years who have started not just private offices, but actually mobile offices that have gone to patients' homes and they utilizing advanced practice providers, using DPMs, using MDs, DOs. And so, this needs to be, I think, considered as well in this.

One of the things, when Caroline is speaking about doing TCOMs and other advanced therapies at private clinics to maybe not be able to do well, or may not have the training to understand that, you know, doing this on edematous legs may not be as accurate as those when you finally get the edema down. It's really referrals. You know, I've had the opportunity to work in industry now for over about a year and a half or more and travel the world and help other healthcare systems like NHS try to deal with their shortcomings. One of the problems is we don't get referrals done quick enough to those specialists. You know, be it, you know, a wound care specialist like Caroline Fife or Dr. Perez, who is vascular, you know, or just individuals in private offices that may not have the overhead to have specialty, or high, you know, more advanced therapy in stock deep where these folks can be, you know, put into wound centers that may be able to handle these types, or into, you know, a vascular center or whatnot. So, I think, you know, a way to encourage referrals, considering site of service is a new expansion in the last three years of where wound care is being done, just not in hospital-based clinics or in private clinics. Telehealth is another one. And then, you know, I think the, one of the last ones, you know, I was kind of writing my list as we were going along, is, you know, nutrition is one. So, this is old and, as I think Caroline said, needs to be revisited again; but I think not just in what we are giving but how we are utilizing it or paying for it. Private clinics don't necessarily have the ability to hire a dietician, even in hospital-centered clinics we struggle to do that. You know, they have their own department, they are asked to come in only on certain days. But if we actually had a way to bill for each visit for each new patient, or patients who are failing their initial evaluations on a nutritional level I think we would see better outcomes, better compliance when we are trying to manage diabetes as well.

And so, you know, and I'm going to end on the fact that when we talk about, I'm going to go way back to the beginning when we talk about this. You know, wound blotting and biofilm, part of what's been startling to me, having been Program Director for Duke and still having an appointment with Duke University for their Hyperbaric Wound Center, and actually hold an appointment at Western University, having had, you know, a decade of training podiatrists, training fellows from all specialties, you know, from cardiology to occupational medicine going into hyperbaric medicine, you know, the variation of debridement across the nation is just, you know, a problem. And it gets to the problem in the sense of how people remove biofilm with the debridement, how aggressive they are. You know Randy Wilcock and Greg Schultz and a consensus group got together trying to develop a step-down, step-up procedure, or a guideline to get folks to be more aggressive in the debridement. But this is one thing that will hinder us if we don't somehow, you know, do better with this. A 40-hour course doesn't necessarily, you know, take clinicals into it, risk factors in the sense of having the nurse practitioner come onboard. We would train these folks for four to six months clinically just before they could stand on their own. And then also there is just the - so the blotting issue with these new technologies work great in the sense that maybe they can show us there is biofilm, but we can't remove it if you are not debriding it appropriately. And if they are not quantitative, they are always going to be there, so it's kind of like when you teach people when they are taking cultures, don't treat the culture, treat the wound. You know, if the culture is positive but the wound is improving, well then you may not need to do anything more than what you are already doing.

And then there is ways to tie in, you know, the vascular studies. You know, at Intermountain we had to institute ABIs on all patients that were getting compression wraps through home health because there were times when patients were getting too tight a wrap or getting wrapped inappropriately. So, you know, if someone has a venous insufficiency diagnosis, you know, there could be a need for an ABI still, just because you want to make sure you are not going to turn their foot blue. But there is a way to tie those codes and put filters in in the guidelines to flag things for review, and therefore you are doing less review. You know, as Gary says, doing audits is not the funniest thing. So, you know, there is things that we can do, you know, in the sense of reimbursing ABIs I think or (inaudible) test the toe and making sure that those are easily accessed, increase access to dietary, increase nutrition. And increasing access to telehealth to help us offload busy clinics and to work more closely with our folks who are at home. And I hope I didn't go too long on that.

DR. LARRY CLARK
Thank you, those were really valuable points. Linda let's go through the questions and then Dr. Dennis Orgill will open us up on perspectives on the skin substitutes. So, Linda, let's go ahead.

LINDA MEYER
Thanks, Dr. Clark. Before we get started, to ensure that all of our CAC Members can vote, you should be able on the right-hand side you'll see the key questions, each question will come up. But I do need, Dr. Keating, are you able to accept a request to become a presenter and vote? And the other -

DANIEL KEATING, DPM
This is Dan Keating. I tried to launch this Adobe Connect several times and it just doesn't seem to want to load.

LINDA MEYER
Okay, then we do have the ability, because for the final record we will include all votes, so we will send you the key questions for you to submit to us. And you can follow along and, like I said, we'll get yours in for final record. And then, Dr. Aronowitz, are you able to accept the request to vote?

JOEL ARONOWITZ, MD
I exited out, unfortunately. Can you resend it?

LINDA MEYER
Thomas, are you able to resend it? We can have our technical support send it to you, absolutely.

JOEL ARONOWITZ, MD
So, I hit download Adobe Connect? Launch.

LINDA MEYER
It looks like you accepted.

JOEL ARONOWITZ, MD
I did?

THOMAS JONES
It shows accepted, but he has not moved up.

LINDA MEYER
Are you able to confirm? Okay. Well, we will continue with our questions. If you do not see the capability again, we will ensure we get your ratings for the final record. We will go ahead and move on with the key questions. And we do have seven key questions for our members. As I said, we have seven key questions for our CAC Members to address. And CAC Members, as I alluded to, you'll see the question box on the right-hand side of your screen. For each question, select your confidence rating in the voting box for each of the questions. When all CAC Members have voted it will show a complete list of nine. We will close the voting, the electronic votes, and then display those overall results and then -

KARA COUCH, CRNP
Hi, this is Kara Couch. I'm sorry, I need to chime in. I'm really concerned, we haven't discussed any of the evidence that was considered, you know, whether it was, it is appropriate or not. You know, we were sent everything, but we really didn't have a discussion amongst ourselves. And I had a concern that a lot of the evidence was in RCT format, which I understand is, you know, what's been considered the highest level; but that's not what we see in the real world. We are not considering real world effectiveness data.

DR. LARRY CLARK
That's (inaudible). Right. Kara, we are going to come into that into the next phase. So, if you go through the questions, we will pick that up.

LINDA MEYER
Thank you, great question. For the attendees, all questions refer to the wound care and cellular and tissue-based products, so CTPs in the Medicare-eligible population only. So for each of the voting questions we do ask that you use this scale you see on the screen, or that has been presented to you, which is a 1 to 5 rating, 1 being a low confidence and 5 being a high confidence. So, I'll go ahead and move onto the first question. How confident are you that current wound care guidelines and published evidence accurately represent reasonable and necessary care for diabetic foot ulcers? CAC Members, please vote.

UNIDENTIFIED CAC MEMBER
I'm not seeing a place to vote for this, or I'm not seeing a place to vote on my screen and I'm in the app.

LINDA MEYER
It looks like we have all nine. Okay. On the right-hand side do you see there is a voting on the right-hand side? It does look like we have nine members voting. Okay. We'll send you - thank you for that. We'll send you the list of the questions and then you can vote on paper. Thank you for that notice. It does appear that we have all members voting. Thomas, please go ahead and close the voting, and we will display the results. We will display the results for each question, we will not do a discussion at this time as Dr. Clark talked about, there will be additional discussion after we do the voting results. Okay. Thomas, you can remove the results. [No results in audio file.]

We'll move onto Question 2. Okay, Question 2: How confident are you - so was there a question?

JOEL ARONOWITZ, MD
Yes, this is Dr. Aronowitz. If you could just send me the written form also, please. I can't answer the - I can't vote on this. I can see the slides but not vote. Thank you.

LINDA MEYER
We will. Thank you for that note. So Key Question 2: How confident are you that current wound care guidelines and published evidence accurately represent reasonable and necessary care for venous ulcers? So those who can electronically vote, please do so now. Okay, it appears we have all electronic votes and, Thomas, you may close and go ahead and present the results. On your screen now are the results to Key Question 2 for those who could vote electronically. Thanks, Thomas, you can remove those, and we'll move onto Key Question 3. [No results in audio file.]

Key Question 3: How confident are you that current wound care guidelines and published evidence accurately represent reasonable and necessary care for pressure ulcers? Okay, it does appear you can close the polling, everyone has voted. Please present the results. On the screen now you see the results for Key Question 3. Thank you, Thomas, you can remove the results. We will move onto Key Question 4. [No results in audio file.]

Okay, Question 4: How confident are you that published evidence supports the use of CTPs for healing diabetic foot ulcers? Please vote now. Okay, Thomas, you may close the poll and please display the results. This is the results to Key Question 4 for the electronic voters. Thank you, Thomas, you can remove the results and we'll move onto Key Question 5. [No results in audio file.]

Question 5: How confident are you that published evidence supports the use of CTPs for healing venous ulcers? It looks like all votes are in, please close the poll. And you may show the results. Show the results to the electronic vote for Key Question 5. [No results in audio file.]

Okay, we'll move on to Key Question 6: How confident are you that published evidence supports the use of CTPs for healing pressure ulcers? Please vote. Thank you, all votes are in, please close the polls and we will show the results. Here are the results to Key Question 6 regarding CTPs for healing pressure ulcers. [No results in audio file.]

We will now move onto our final Key Question, Question #7. And that is: How confident are you that there are not differences in effectiveness between brands or types of CTPs? Okay, it does appear we have all votes in. Please go ahead and close the poll and show the results. Here are the results for our final Key Question on the confidence on effectiveness between brands and types of CTPs. [No results in audio file.]

Thank you to our CAC Members who were able to vote, and for those who were not able to electronically vote we will send you a paper copy, and we will include your results and voting into the final record that will be published. On that note, Dr. Clark, I will turn it back over to you to continue the discussion.

DR. LARRY CLARK
All righty. We are moving into a discussion of another aspect of the wound care. This part will be separated out in a separate Open Meeting. And as I acknowledged at the beginning, obviously two hours I think that any one of these topics that we have touched on could take two hours. But I think again to focus direction of a potential policy and to get your suggestions, also to hear the concern that Kara Couch raised. I want to start Dennis Orgill can you give us an overview of where you think this aspect of wound care is headed? And do you think there is anything that needs to be specifically addressed in this policy? And Dennis, could we make sure your volume is good because, you know, we are trying to make sure, even though we are having difficulties we want to make sure this gets recorded.

DENNIS ORGILL, MD
And you know we have wonderful representation on the call -

DR. LARRY CLARK
Super, thank you.

DENNIS ORGILL, MD
... out of different areas. And I think there has been a lot of innovation in this field, and we have a lot of new ideas, and a lot of products on the market now, and a lot of things that are in development now. And hopefully these products will lead to faster healing of our wounds and closure. And there are many ways to classify these devices. One could be what's actually in the product or device, and what it's intended to replace. Does it replace the epidermis? The dermis? Does it induce wound contraction? Are there cells that are live in there? Are they autologous? Are they from a cadaver source? Where do they come from? Are they terminally sterilized or are they not? So, there are a lot of differences in these products. One of the things that's happened in the marketplace as I see it is that companies, in order to have a viable business, need to get the products approved from a regulatory standpoint. And they need to convince people to pay for it. Those are the two hurdles that they have. And the regulatory hurdle to do a good study to show these where typically you might need 100 patients in each group to show a difference. These are pretty expensive studies and a lot of the particularly small companies don't have the capacity to do that. So, as I look at the product landscape, I see a lot of products that are based on a 510(k) mechanism. These would be primarily devices. And then a lot of products that are based on autologous or cadaver-based material that in either one of these mechanisms do not have the really regulatory scrutiny of like a Class III medical device or a drug that would need to go through the FDA. And so, then you have the interesting thing where you have some products that have had pretty reasonable studies done, and we've talked about those in the past. And then you have a new product come on, and then the question is does that product need to repeat that study to show that it's different? Or can they just rely on the work that other people have done? And so, understanding that is very interesting. And then someone mentioned the whole financial aspect of the practitioner, which I think really comes into this. And a lot of products are (inaudible) needs to make money doing this as well both on the professional phase and on the product phase. And so, a lot of methods have come across in kind of (inaudible) application. So those are (inaudible), but we have a lot of products now. The average clinician can only stock a few of these in their office, and they very often (inaudible) a dominant carrier they are using will pay for it. And so that's (inaudible). So, I think I'll stop here and open it up to other people.

DR. LARRY CLARK
(Inaudible)

CAROLINE FIFE, MD
Yeah, this is Caroline Fife. My -

DR. LARRY CLARK
Does anybody else like to make a comment at this point on where we are at?

CAROLINE FIFE, MD
(Inaudible) that already kind of that RCTs are necessary and we understand why the world works the way it does. We've looked and published extensively on the lack of generalizability of nearly all of these RCTs to real patients. And as a result, we really don't know how well any of them work in the real world, even if they've had exhaustive RCTs because the patients are not who we see. So, when we've looked at this very systematically, even in the same clinics that are doing clinical trials as well as seeing real patients, they enroll Wagner I DFUs, they see Wagner 3. They exclude arterial disease. They enroll venous ulcers that are three to five times smaller than they are, and most patients have three venous ulcers when only one is studied. So, my huge concern continues to be that we don't know how they work in the real world without real world evidence.

STEPHANIE WOELFEL, PT
This is Stephanie. I would agree with that comment as well.

DR. LARRY CLARK
Yeah, go ahead.

STEPHANIE WOELFEL, PT
We do a lot of research out of our Limb Salvage Clinic at USC and have a pretty difficult time with subject recruitment sometimes because of the exclusion criteria. And you know as Dr. Fife said, as terrible as mentioned, these are just not the actual patients that are in need of these products. So, I think we need to be mindful of that when we are reviewing -

WILLIAM TETTELBACH, MD
This is Bill Tettelbach.

STEPHANIE WOELFEL, PT
... to make sure that it's evidence that we could actually generalize to some of these patients.

WILLIAM TETTELBACH, MD
Yeah, this is Bill Tettelbach. I was -

DR. LARRY CLARK
Stephanie, which -

WILLIAM TETTELBACH, MD
I'm getting a little feedback.

LINDA MEYER
Dr. Tettelbach, (inaudible)

WILLIAM TETTELBACH, MD
Yeah, so I agree and disagree with Caroline's stance on that. I do agree that, you know, not all studies have, you know, as strict a criteria and do reflect. But the thing is, you know, when you work in a hospital center or an academic center you may very well be getting more of the worst of the worst. But I think a lot of the private clinics may be seeing folks that don't carry as many, you know, most of these patients do carry two to four comorbidities. But again, you know, when you generalize that, you know, folks who are on hemodialysis, that generally reflects maybe 10% of the population. And those who are on chemotherapy, those are maintenance patients. And we are not looking to necessarily heal those folks until they get off hemodialysis, I mean, I'm sorry, off of chemotherapy. So, I think we need to not be so broad as to, you know, set the expectations of where things are engaged, on what patient populations and, you know, really think that through. I think the fact that, you know, a lot of these, or you are saying all studies don't reflect that. I think some of these actually do and maybe reflect it more in areas that we don't practice in, but yet get the sort of the more complex patient. And that kind of gets back to the referral system where somehow we need to encourage referrals to get folks who are more complex into areas that may be better served with people who are more expert at this as yourself. Or those, you know, like at USC. Not all having trained, you know, years of these folks, not all folks even graduate with formal training with the same depth and expertise that is reached with the years that you have done and dedicated to research, or all of us in this group. So, I think we may, you know, have a little bit of a different, you know, lens on being that, you know, I think our experiences go beyond the majority of the would care docs out there.

DR. LARRY CLARK
Marty, Marty Johnson, what is your perspective?

MARTIN JOHNSON, MD
Yes, again I didn't introduce myself earlier. Marty Johnson, I'm Mayo Clinic in Arizona. I have no conflicts of interest. You know, the other thing that we've been looking at since one of the five pillars that Mayo has established for us is regenerative medicine. So, we are looking at not only the CTPs in that category, but the complex wounds where we might need something to cover bone or tendon or the like. So, we are looking at the PRP products at this point, and hopefully that it will add another arm to, or another tool for the toolbox to take care of these complicated patients. I mean obviously we are a tertiary or a quaternary referral center, and the people we see are pretty darn sick and require a lot of advanced therapy. So that's where we are right now, we are evaluating some products that involve the patient's own PRP.

DR. LARRY CLARK
Thank you. Anybody else want to - Kara Couch, want to state your question or concern about CER interjected? Did Caroline represent your opinion well? Is that your concern, because I will say you do again go back to what Dr. Grossman and Dr. Keating said, that replicating clinical research in an office-based setting, they both encourage more care evaluation at the front line. I'm not sure that's anything we can handle in a policy, but I think that we could make it a thought. Is that correct?

KARA COUCH, CRNP
So, I would give a specific example of a patient of mine who has (inaudible) venous disease, a large ulcer that was about 12x10 cm, had been present for three years and had already failed grafting previously. So, cleaned him up, did the standard of care, compression studies, etc., and then he was ready for a CTP. Well, you only get so many per year, 12, I'm in the Novitas region so we get 10 applications in 12 weeks. So, you start getting this large wound reduced quite dramatically, and it's been progressively improving all along as you are applying these products. Well then you get it reduced by about 75%, and its' only April and you are stuck and you can't apply the, you know, process that had been successfully helping this patient to heal. So I think that's something that we should definitely look at, and that's where these comparative effectiveness trials are looking at, you know, this is not a patient that has a 1x1 cm venous ulcer where we really need to consider the real world aspects of patients that we see in our clinics. And, you know, whether they are from, you know, poorer parts of DC or members of Congress, you know, it's a whole wide range. And if we are only considering RCT data we are doing a disservice to our patients because that's not what we see in our clinics.

DR. LARRY CLARK
So, let me just - go ahead.

DR. GARY OAKES
This is Gary, let me - Larry, if you don't mind, just real quick. Yeah, I was going to say if you get a case like that and you are making great progress there is, I know it's a pain and forgive me for even bringing it up, but touch base with the Medical Directors because more often than not we can do an individual consideration based upon the facts of the case. The policy is there for the majority of the cases, but when you get an exceptional one like that, at least in Noridian, if you were to shoot an email or even send it in as a Redetermination, more often than not we would work with you on that.

JOEL ARONOWITZ, MD
Can I make a comment? It's Joel Aronowitz.

DR. LARRY CLARK
Yes, please.

JOEL ARONOWITZ, MD
You know, I just want to reiterate those, thank you for your suggestion, I just want to reiterate those comments that part of the problem with the policy is drafting a policy that's specific to anatomic locations. Not that they are, as Dr. Perez pointed out, there obviously are differences between a wound caused by an arterial insufficiency at the large vessel or small vessel level and/or by a, you know, diabetes, that diabetic malleolar wound, but the basic biology of wound healing is the same wherever it is. And for doctors that are treating wounds at any anatomic location, if the guidelines are specific, if the guidelines arise strictly from the literature, and the literature, the study has been designed to look at a specific anatomic location then our hands are tied in terms of using what would otherwise be the perfect product in a location that wasn't specifically studied. And I hope that we can move the policy toward allowing the clinician freedom to use the material in anatomic locations that are more broad, and in amounts that are reasonable in relation to the size of the wound. That's all. Because that would help us, that would help us out a lot, especially for the people that are in noninstitutional settings where the cost of the material.

WILLIAM TETTELBACH, MD
So, this is Bill Tettelbach, so I think -

JOEL ARONOWITZ, MD
... if you are stuck with, you know, eating the cost of material it becomes prohibitive.

DANIEL KEATING, DPM
Larry? Larry this is Dan Keating. Larry, this is Dan Keating, I also think when you look at the future of this something we haven't added into this, and maybe it's going a little too far, but the negative pressure wound vac in combination with the skin substitute, if the wound is optimized on the cellular level and the vascular status is there, I think that has to be at least on the mind of all of us. That type of thing (inaudible).

WILLIAM TETTELBACH, MD
This is Bill Tettelbach. I just wanted to comment on the last two and even on the third that was just said. So it's interesting, so trying to build a policy just with the RTC, you know, like data or, you know, retrospective data, or even real world data, you know, gets in the way of really what all the practitioners, you know, observe. So since day one, I think since advanced therapies have been available be it from, you know, from, you know, from an animal source or whatnot, and now we have bioengineered to the placental derived, but one of the things is when a wound got to a certain size and you thought it would heal one of the first things you kind of found out as a young, you know, practitioner, you think oh this is going to heal on its own. And then you stop what you are doing, go back to standard of care, it stalls, and they start getting bigger, and you really learn that sometimes you have to follow through, you know, with what you are doing to get to the very end. The other point, you know, what Gary made, is putting in a recommendation well if you reach the end and then it takes weeks to a month or so you may be slowly getting back to where you started from by the time you get approval. So that, you know, that's a difficult situation. And then again I think also we have to start thinking about, you know, if there is evidence that certain things work, because, you know, I think looking at the, the voting and, you know, there is, was a consensus that maybe not all of these products are the same and maybe we should be using products that have evidence. But the thing is I agree with Joel in the sense that, you know, if I correct the underlying pathophysiology of a wound, say you know, the diabetes is actually better controlled so there is actually better protection of the immune system, and I get revascularization going so that, you know, there is better perfusion, so these are sort of the pathophysiology that hits these wounds. But you know, an abdominal wound which has good perfusion but yet for some reason has stalled and there is biofilm and the upregulation of MMPs is not completely being addressed with the standard dressings and you may need something more, you don't have the freedom to move forward to get that patient out of the, with something else to get them out of the clinic to make space for a new patient who needs something more urgently. So I think that's where, you know, we could think about things in pathophysiology or actually logistics in the sense that, or you have a location anywhere in the body but if that's an irradiated tissue that's going to behave differently than just say any wound. So maybe there needs to be good evidence on how we work with irradiated wounds. And I think with negative pressure that's a great, you know, we've been using negative pressure, the plastic surgeons have been using negative pressure to bolster split thickness skin grafts for a long time. And bolstering a product that actually has some activity to it that you need to be as close to the wound bed as possible makes sense. And actually, I think there is now experience out there, we just don't have it written up that actually works. So, these are things that where I think these type of conversations are definitely needed to help guide these type of next steps to improve how the delivery system is for wound care. Thank you.

ALEJANDRO PEREZ, MD
Yes, just a quick comment.

DR. LARRY CLARK
We have two more comments queued, one of them from Dr. Perez and that will be followed by Dr. Alexander. Alejandro?

ALEJANDRO PEREZ, MD
So, (inaudible) did a review for CTP skin substitutes back in January of 2019 and their concluding statement was the current evidence base lacked studies comparing many of the skin substitutes to standard of care and to each other. And that even the future trials don't address these questions. And that being said just, although we can all agree we have anecdotal stories of skin products helping our patients, I think the only thing that we can all agree on is you have to address the basics and that's arterial flow and venous flow. And if that's adequate I think that's, that's the standard of care when you look for advanced modalities. But if you haven't moved past, you know, step one then, you know, these more advanced therapies are still kind of adjunctive rather than primary.

DR. LARRY CLARK
Thank you. Jim? Jim Alexander, hello? Are you on there, Jim? Hello? Gary, you still hear me?

DR. GARY OAKES
Yes. And can you hear me now?

DR. LARRY CLARK
Hello?

DR. GARY OAKES
Yes, yes.

DR. LARRY CLARK
Do you hear me? Dr. Alexander, you had your hand up.

JAMES ALEXANDER, MD
Basically, this has been a very good discussion. I'm glad, I think that was Dr. Perez raised the issue related to the ARC reviews. And I thought the interesting thing was to me, as I read these, and you can look in the tables, they are really good tables, Table 14 about randomized controlled trials in 2012 and then Table 18 and 19 about the RCTs in 2020. And when you take all those things together and you look at them and you look at the results, the results are striking that these agents, many of them very different, do have improvements in the majority of cases that are very impressive. You know, relative risks 1.5 and above for healing, and then healing times that are also show, you know, concerted decreases in just almost all of the studies. And that tells me that, you know, that these things work. And I'm sure some of the newer products that have chosen not to do RCTs and accept their maybe do cohort studies and such like that probably do also. So, I think any LCD that's made should make room for products that a given practitioner who does a good job on working the patients up and then decides to use one of these has the option to use it for whatever. As a surgeon I talked with Larry about this, you know, I've found certain products in my surgical practice I like just because they handled nicely, or they, you know, they seemed to last longer on the wound than others did. And so I think my recommendation related to the policy is going to be how do you get to a point where people who have knowledge, like obviously so many of you do, can use the product that they think is going to work best in this particular patient based on either a randomized trial that they are impressed with, or a probably the predicate device for a 510(k). I mean one of the things when you look at the 510(k)s you need to see what the predicate device was that the new product is being compared to. And sometimes you'll find it's being compared to a product that really has a good RCT behind it, and it's considered a predicate of that device. So that's good scientific evidence also. So, my comment would be there is a lot of information out there, and a lot of information showing these things work. The question is how can we get it into a policy that's going to, you know, allow the best products to be used by the best practitioners for the best clinical outcome? That's all, that's all I would say on that.

DR. LARRY CLARK
You know, you and I touched on this when we spoke before this call, and from a policy perspective I talked about the pushback, the acceptance, the good medical care that may be derived from requiring just a three or four sentence rationale for the choice of the product used. Did you think that was an unreasonable policy initiative, or do you think that was consistent with good care? I mean that was one of the recommendations. One recommendation that everybody on this panel agreed to was appropriate vascular evaluation prior, you know, early on, within the first week of the initial wound assessment that you would assure the vascularity.

JAMES ALEXANDER, MD
Yeah, I think that that is one of the things -

DR. LARRY CLARK
But how about that concept of a rationale for the choice of the skin substitute?

JAMES ALEXANDER, MD
... related to documentation in the section on LCD where you have to specify, you know, if somebody needs to be looked at that a rationale should be present in the record as to why a practitioner, either a physician or nonphysician practitioner, chose a certain product in a product that would be necessary related to a nonhealing wound. That would, if that chart was looked at under review it would be passed because it would say well this is a reasonable product, it has an FDA 510(k) clearance and it's being used in an appropriate way. And when you look at the record I think that really is one way in policies you can assure that good medical care is being carried out, and as to whichever product a person wants to use when those are necessary beyond where the guidelines breakdown and you get a nonhealing wound.

DR. LARRY CLARK
Okay. And the other one, which I'm going to again kind of throw out, it was something that Joel Aronowitz and I sort of derived out of conversation. He was talking about the strength of the Cedars Sinai faculty, I suspect this is something that Dr. Orgill's group enjoys, you know, Mayo, not everybody has that benefit. But what we can suggest and, you know, require maintaining documentation of a list of consultants that you use, so that when you get to a decision point in the care of the patient you at least have that subtle reminder that, you know, wait a minute, has this patient been to their internist or endocrinologist lately? Are we doing what we see, which is somebody who is going into another course of protracted wound care with no evidence of success? But then you check the chart and the A1C is 11.2, if it's in the chart at all. So you know, those are just some of the things that we are, we are pondering and are going to come back, you know, we will be coming back to in the subsequent discussions as we develop the policy. I think Bill Tettelbach has his hand raised. Bill, do you have something else to add?

WILLIAM TETTELBACH, MD
So yeah, I mean so I think the documentation, you know, as an ID doc and every practice I continue to practice because, you know, wound care, you know, tons of wound care patients are affected and you need an ID doc as well. But you know, institutionally I've been in several. You know, I've worked in the Methodist System, the Methodist Le Bonheur System for almost 10 years, I worked in the Intermountain Healthcare System for almost 20 years and, you know, all of those systems, you know, when you order antibiotics, you know, the policy is you have to put a justification. So, I don't think this is anything new, and putting a short, you know, a one sentence or even three words why you are using it would be acceptable. And I think keeping a list of consultants just reinforces the fact that we are supporting the notion that this is a multispecialty specialty, which this panel, you know, clearly reflects and that we need to have a true, you know, wound care success. You have to have all of these folks onboard at one point or another. The other thing that kind of gets in the way, you know, we keep, you know, swinging back to the Sheehan paper on the 30 days 50%, you know, 9% chance of healing at 12 weeks as a statement before starting some advanced therapies. But we also have the Labret data from 2006 that basically states that after 30 days you are 4.7 times more likely to get an infection. And when these diabetics get infections, they are 55 times more likely to be hospitalized, and 155 times more likely to be amputated. So, the thing is we are always in a race to, you know, get these wounds closed and get them out of this, you know, area of high risk and life changing events. You know, once they get below the knee, as everyone knows here, their risk, five-year mortality rate is 50 to 80%, you know. Even two year I think is, you know, 26 or something like that. But the thing is if you have patients who come, and this is part of the documentation, if you have patients who come who have already been seen somewhere else and attempted standard of care, or even, you know, suboptimal but yet attempts to heal these folks, you know, waiting another 30 days is just not necessarily in the patient's, you know, best interest. If you already know they already have 30 days, but sometimes it's the first day they hit through the door, or you can't get the notes to do that; but the patient conveys that to you, and sometimes that's very misunderstood. So, it would be nice to have in a policy that really sets that out and allows that flexibility. So even if you waited two weeks to get, you know, a handle on what the wound is going to do with standard of care would be better than waiting three, 30 days. I would be curious to see what other people think about that, or if they run into that problem.

JOEL ARONOWITZ, MD
Joel Aronowitz here. I think that that point is very well taken. These kind of arbitrary, conservative guidelines do more harm than good, in my experience.

DR. LARRY CLARK
Anyone else on that particular topic? And Linda, do we run out, do we have a hard stop at 7:00, do we lose our connection?

THOMAS JONES
Nope, we can continue.

LINDA MEYER
This is for Thomas. I am going to ask you if that can be answered by your technical support?

DR. LARRY CLARK
All right, these folks have already given two hours plus, plus a whole lot of reading and a whole lot of time; but I do think that was an interesting challenge that Joel put out. What are the opinions of the other folks briefly on this issue?

STEPHANIE WOELFEL, PT
So, this is Stephanie.

DR. LARRY CLARK
Go ahead, Stephanie, then Alejandro. Stephanie?

STEPHANIE WOELFEL, PT
Okay. So just having some experience with this in the PT world from the standpoint of the national coverage decision related to electrical stimulation, because that does require a 30 day standard of care prior to being able to initiate, you know, electrical stimulation. You know, we've successfully treated where as long as we can establish that that 30 days has occurred prior to the patient coming to us that we've been able to initiate the intervention, you know, on the day of the evaluation. And that has not been an issue. So I agree that the policy needs to at least give the opportunity that if you can establish either through the patient report, the documentation that comes, your conversation with the referring physician, you know, whatever it might be that that patient has already had standard of care for the, you know, for a window of time. That some of these more advanced interventions could start immediately as long as we've met our burden as far as making sure that there is the appropriate vascular studies and all of the kind of good care that we have been talking about kind of this whole time. Just because I feel as though, you know, I think Dr. Fife mentioned it and I think we all live this every day, we see a lot of patients that come to us after having a wound for three years. So, to make them wait another 30 days when we are maybe the fourth or fifth person that they've seen for this wound doesn't seem like it's in the best interest of the patient. So, I think the policy should find a way to address that.

DR. LARRY CLARK
Alejandro.

ALEJANDRO PEREZ, MD
Yes, so one of the programs that our hospital started, there was a tradition that basically the mission said I want (inaudible) pretty much there was a passthrough and we would admit them for observation. But there was a couple of years ago we had some reimbursement issues and the hospital asked us to look more closely whenever one of our clinicians requested a skin substitute to make sure if everything was optimized. And what we found is, you know, sometimes, you know, offloading was not optimized, or compression was not optimized, or the patient wasn't being compliant. And so unfortunately that meant that, you know, the patient wasn't optimized from the basics. And so we actually cut down our probably use of some of these skin substitutes by 50%, and so some of the complaints from our clinical, you know, practitioners were well now the patient healed too fast so they don't qualify for the skin substitute. And, you know, in my mind well that was the whole point. If you did, you know, the basics better they don't often need these things. And so, I think that's the thought behind this waiting period. I agree that in a lot of instances this can relate to delay, but this is because there are some clinicians who, whether it's in the private practice world or in an academic world where it's RVU that they are held accountable to, that, you know, if you can do a skin substitute early on there is some sort of, you know, there is a motivation to use these things. And so, I think this is almost a protection for the patient to make sure that the basics are done so that before they move onto something more expensive and have an unpleasant bill to have to deal with. That's the other side, I guess.

DR. LARRY CLARK
That is the other side to the coin. And there is not just an economic barrier, it is a time to assess the patient's care. And that's interesting. Dennis Orgill, are you still with us, sir? Yeah, how do you handle this from, you know, what you are doing at your center is essentially looking at different products in an academic wound care setting. How do you handle this issue? What do you do, and how do you standardize what you are doing?

DENNIS ORGILL, MD
Yeah, I think it's (inaudible). But there may be some unintended consequences. I can tell you, every year we see several patients in our wound care center who have been on, you know, product after product at different places. They get referred in, and we just do a little skin graft or even, you know, do the compression right on venous stasis ulceration, or offload them on the diabetic foot. And we can get a lot of them healed without using these things. So that the question is the balance of using these on something where it's going to help, and I am encouraging clinicians to do the basics before you start slapping a lot of expensive product on, which in many cases is going to be a futile exercise. And to try to determine who best does that is good. Now Caroline made a nice point that the RCTs are not valuable, but they still are the best thing we have. Compared to a lot of products that don't have any data at all on them, they do provide at least some data. So, I still think there is a place for RCTs. I do think, you know, we are learning more about registries and those are probably going to be important for real life data as well. But I think we should, as physicians, we should push for better data as well, both RCT and registry studies.

DR. LARRY CLARK
Thank you. Anything else?

JOEL ARONOWITZ, MD
Larry, this is Joel Aronowitz. If I could just very briefly add, first I don't think that, I don't think that having a arbitrary time to reassess the patient is going to protect the patient from bad medical care. I think the only thing that protects the patient from bad medical care is an advocate with the patient, or the patient able to advocate for themselves. I do think that somehow encouraging the more widespread use of registry would be very helpful in terms of collecting data. And I think Caroline made a great point on that. And if there is a policy method to encourage the use of registries that, that could be a big step forward.

DR. LARRY CLARK
Yeah, you heard though what my colleague Dr. Oakes said. I mean that would be an exceptional step for us, and probably something that would involve CMS. It would not be at the contractor level to be able to do that. So I would look at that, you know, agreed, I don't think any of us disagrees that really - you know, you can look at things by Q codes, you can look at what happens to the patient by diagnosis codes. I think you are really getting down to the heart of the matter, is that something that we can do? And I'm just not sure, you know, what people are going to say. I mean it's something that's, you know, now on the table so we'll talk about it but, you know, we can't make promises for what we don't control. I just want to be honest about that. I think Bill Tettelbach had his hand up again, and then I think we have certainly prevailed on you, and I will be asking - let me just go over before I turn it over to Bill for a last comment. I want to thank each and every one of the panelists for the time they have put in already. There is literature and things that we have not yet reviewed with you. There is directions for these policies, and it will now branch off into two directions. I think you've given us at least a place to start, and we will appreciate your continued support and feedback, and also your written commentary because, you know, certainly this is an opportunity for each of you and your specialties. You are, on the record in the history of this policy as contributors so we can certainly benefit from your expertise. I think there is a real diversity and just a whole lot of talent here that we can use, so we will be back in touch, you know, with just appreciation. And also to our policy staff, our, you know, analysts and the people that helped us at Noridian, our technical staff, and, Bill, if you want to get the last comment and then we will get back to the rest of what we have to do today. So, Bill?

WILLIAM TETTELBACH, MD
Yeah, yeah, so I just wanted to progress along with this discussion. Timely referral keeps coming back and getting the right things done and when people show up. The reason I threw two weeks out there is because most of these RTCs are the ones that are done with guidance set by industry, and I think I've had a discussion with Gary Oakes about this is that, you know, there is a two week run-in period, you know, that is used already for, you know, folks who are setting up these type of tests, you know or studies be it, you know, industry or being government funded or privately funded. But, you know, the thing is if you are not seeing say anywhere from 20 to 30% reduction in two weeks well then that's a marker in itself that can be used. You know, if a patient comes in and you do what Dr. Orgill said, you know, you start from scratch. That's actually a good thing to do, we don't do that enough, we don't start over sometimes to find out why things aren't going the right way. So, you know, if that standard care is working and you are getting greater than 25% in two weeks then you continue on with that. But it's, you know, and if you are not having more than 50% at four weeks then maybe that's a trigger point to go to something else. But that's why I think you make sure you are getting things done right, making sure the wound bed is prepared because there is two steps in all of this. There is wound bed preparation and then there is closure. And so, when your wound stalls, you know, you start going to what you need for the closure side, which is part of this discussion. What's also interesting is the Medicare data pans out on itself as just showing, you know, if you go and take a look at Medicare data, you know, people just aren't using the advanced products according to how the studies use them, or even how the instructions are used. So, this is another thing that needs to be looked at are the outcomes that all of us are seeing inconsistent? Or other people that send them to you who are using the product, are they not using it according to the way they should be using it to optimize for the patient? And the fact that you are using it the way it should be really makes a significant impact on that. So that's a whole other discussion in itself I think that we need to visit later on possibly. And this has been a great evening.

DR. LARRY CLARK
Good point, thank you. Thank you. I just want to say thanks to everybody and I really want to just, you know, on behalf of Noridian, thank you for working with us and we look forward to your continued help as we progress through the policy development. And thanks to everybody that stayed on the call with us tonight. Have a good evening, bye, bye.