Wound Care Local Coverage Determination Open Public Meeting - February 24, 2021 - JE Part A

Jocelyn Fernandez:
We are still waiting for a few more presenters to call in. However, it is already 12 PM Central Time and we know your time is valuable. So, let us begin the meeting and hopefully, they will call in when it gets closer to their time to speak.

Good morning and welcome members of the public to the Open Meeting for the Proposed LCD Wound Care. LCD number DL38902 for Jurisdiction E and DL38904 for Jurisdiction F. The meeting will be recorded. The audio recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered presenters will be allowed to comment during today's meeting. For the registered presenters, each of you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Remember to unmute your device to ensure that your comments will be heard. You should be prepared to begin your presentation immediately when called upon and will hear the moderator’s voice when one minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during your presentation. All comments made today should also be submitted in writing. While only those registered to present will be commenting today, anyone in attendance may submit written comments. The comment period ends on March 13th, 2021, and comments can be e-mailed to policydraft@noridian.com.

I will now turn this meeting over to Dr. Larry Clark for comments on the Proposed LCD. Dr. Clark?

Dr. Larry Clark:
Hi, thank you, and thanks to both Jocelyn and Rachel, for the work that you've been done, and those hundred folks that are already on the line, you understand we have 17 anticipated speakers today so if we're a little more structured than usual it’s to make sure that everybody gets adequate time to speak.

We're anticipating about 10 minutes for each of the presentations. This is regarding our Draft Policies DL38902 and DL 38904. A word of apology for the delay on the presentation of this policy. As we were developing it, we found that it conflicted with an older existing policy, Ulcers and Symptomatic Hyperkeratosis, which is directed towards lower extremities and rather than handling confusion with coding, we took the time to retire that policy and integrate elements from that policy into the policy, the draft that we're presenting now.

With that [inaudible] because this particularly impacts podiatric practitioners, we will be concluding today in about three and a half hours with two representatives from the Board of the American Podiatric Medical Association.

So, we thank all of the practitioners and the associations that have led their time in the development of the policy and to our fellow contractors, particularly, Novitas, First Coast sharing with us comments from their policy development period. So, while this is a Noridian effort to address problems in our own jurisdictions, we thank the contractor community for their support in this, as well.

I'm joined today by Dr Ann Capehart, our own surgical expert here at Noridian and if we need, we may just take a one minute Moderator break, if there's anything we'd like to clarify, but hopefully the presenters are well prepared. They certainly seem to be, we have some great slides from some of the presenters. So, we are attentive, and I'm going to try and run this straight through so that everybody gets their chance. Ann do you want to say anything?

If not, then, Jocelyn, I think it is five after one Eastern. So, if we can proceed, let's begin with our first speaker. Thank you.

Dr. Raeann Capehart:
Sorry Larry I think I was muted. I have no idea.

Dr. Larry Clark:
Okay, thanks, Ann.

Jocelyn Fernandez:
Our first commenter is Ms. Kara Gainer. Ms. Gainer, your line is open.

Ms. Kara Gainer, JD:
Greetings, my name is Kara Gainer, and I'm the Director of Policy and Regulatory Affairs for the American Physical Therapy Association or APTA. APTA represents 100,000-member physical therapists, physical therapist assistants, and students of physical therapy. Thank you for the opportunity to speak today. I will be brief in my comments.

Effective wound management incorporates a multi-disciplinary team with physical therapist and physical therapist assistants. Physical therapists perform wound healing procedures and wound care interventions related to pressure injuries, diabetes, and vascular insufficiency among other conditions. Physical therapists and physical therapist’s assistants work across clinical settings, including acute care, outpatient, skilled nursing, and home care.

We wish to provide several comments and recommendations on the Draft LCD for Noridian’s consideration, and we will discuss these recommendations among others in our written comments that we'll submit by the deadline of mid-March. One of our members, Dr. Stephanie Woelfel, will also be speaking today, and whose comments we support.

Within the Proposed LCD, we noticed that and already in use the term skin replacements. We recommend that the Final LCD instead use the terminology, cellular tissue-based products, or CTPs.

We recommend that, Noridian clarify in the Final LCD that non physician practitioners, including physical therapists are qualified to conduct a re-assessment of a wound.

When it comes to the frequency of debridement, we recommend Noridian include in the LCD that frequent debridement suggest a need to re-assess and re-examine the treatment plan to assure that clinicians are addressing all needed facets of care and that frequent debridements are clinically appropriate.

As Dr. Woelfel will discuss shortly, the final LCD should clearly delineate the differences of non-contact low frequency ultrasound versus contact low frequency ultrasound. Contact low frequency ultrasound provides immediate debridement, whereas non-contact low frequency ultrasound, provides bio burden reduction and stimulation of cellular activity.

Within the LCD, Noridian identifies several different debridement methods for chronic wounds. and we recommend that Noridian include contact low frequency ultrasound within this list.

Finally, within the LCD Noridian references evidenced-based clinical guidelines and other published evidence that support different interventions for chronic wound care. There’s a significant amount of evidence to support that exercise should be included in this list of evidence-based measures as exercise improves circulation and improvement of the calf muscle pump to improve venous return and edema. We will provide these studies and evidence within our written comments.

And that concludes my brief comments. Thank you for the opportunity to speak today and to provide written comments in the coming weeks. I will now turn it back over to you.

Dr. Larry Clark:
Thank you. This is Dr. Clark, I'm just going to ask you, you made about seven points and I'm going to say something and then maybe repeat it once or twice throughout the meeting, and that is just a brief reminder that in addition to these comments today and you are being recorded, we really appreciate committing them to writing and send them in.

Jocelyn will be giving you and all the speakers the email address for which for submission, or even the, the physical address for submission and there is a comment period that begins today and concludes on March 13th.

So, if you commit these thoughts to writing, in addition, and then we will be responding to these comments. I wanted to ask you if you or Ms. Woelfel would be so kind as to send the literature, you made a specific reference to ultrasound and decreasing of bio burden. I don't know if we have any literature on that topic if you would you be kind enough to send it. And we have one minute before we move on. Ann do you have any questions or thoughts? Dr. Capehart?

Dr. Raeann Capehart:
[inaudible] No, no I don’t.

Dr. Larry Clark:
Okay, Ms. Gainer, thank you and thank you for your representation of the APTA. Jocelyn.

Jocelyn Fernandez:
Our next commenter is Ms. Donna Cartwright. Ms. Cartwright, your line is open.

Donna Cartwright:
Good afternoon, everyone. I'm very pleased to offer some comments. My comments will remain focused on the coding aspects within the policy, and not so much the clinical. My comments are very detailed, so I will be following up with written documents you know, during the comment period, so that it will provide further clarity. But I wanted to get some of the main points across, next slide, please.

I gave my credentials just for everybody's knowledge, I am a Fellow of the American Health Information Management Association.

I'm an ICD-10 CM and PCS approved trainer by the American Health Information Management Association. And I have a Master's in public administration with a concentration in health services. And I'm credentialed by the American Health Information Management Association. And I have 24 years of corporate experience in this area working for Integral Life sciences. Next slide please.

Topics I will cover is wound versus ulcer terminology that is used in the policy, clarifications that may be needed for the intent of the LCD and the LCA. Proper use of CPT code 97597. Clarification of the term, sharp debridement, debridement concerns and use of modifier 25 with debridement procedures and some coding clarifications that may be needed. Next slide, please.

So, for wound versus ulcer, the Noridian policy provides the definition that a chronic wound is defined as a wound that has failed to progress through normal healing in a timely manner. They generally occur in patients with comorbid conditions such as diabetes or vascular disease. The term wound refers to an acute process such as traumatic wounds, surgical wounds, as well as procedural complications described by ICD-10 CM codes in Chapter 19, entitled Injury Poisoning and Certain Other Consequences of External Causes. The term ulcer usually refers to a chronic process, for example, diabetic foot ulcers, venous ulcers and so forth. Coders need clear criterion to determine whether they need to use a code from the Chapter 19 which are the injury poisoning and certain other consequences of external causes in ICD-10 or use a chronic ulcer code based on the duration of the wound. And, you know, the age-old question is, when does an acute wound turn chronic? You know, is it 30 days and if the intent is to address all acute wounds, I would ask you to consider revising the LCD title to Wound/Ulcer. Next slide, please.

So, I had some questions about what the intent of the LCD and LCA is. Noridian stated in the draft policy, Medicare would expect that wound care may be necessary for the following types of wounds surgical wounds, that must be left open to heal by secondary intention, infected open wounds induced by trauma or surgery, wounds with biofilm, wounds associated with complicating, autoimmune, metabolic and vascular or pressure factors, and open or close wounds complicated by a necrotic tissue or eschar. So, my comment would be, if the intent of the LCD is for both acute and chronic wounds than the codes for the medically necessary conditions, needs to definitely be broadened and expanded to a list of covered ICD-10 codes because it does not have a lot of the acute wound codes in it.

Next slide, please. That's the same slide.

There we go. For the purpose of the LCD wound care is defined as care of wounds that are refractory to healing or have complicated healing cycles either because of the nature of the wound itself or because of complicating, metabolic or physiological factors and they include, this definition excludes the following management of acute wounds or the care of wounds that have normally healed by primary intention, such as cleaned, incised, traumatic wounds, surgical wounds that are closed primarily and other post-operative wound care, not separately covered during the global period. The comment that I have is that this wording leads one to believe that the LCD is only for chronic wounds, because acute wounds, trauma wounds, surgical wounds, and burns are excluded. Acute wounds are coded with ICD-10 codes in Chapter19, injury poisoning and certain other consequences of external causes. Wounds refractory to healing and complicated healing cycles is indicative of chronic wounds like diabetic ulcer, venous ulcer, pressure ulcers and non-specific ulcers. The codes associated with the policy contain traumatic wounds, such as abrasions, lacerations, open wounds, which would not match the intent of the policy if the purpose of the LCD is for those wounds that are refractory to healing or have complicated healing cycles. If both acute and chronic wounds and ulcers are to be addressed in the LCD, Noridian should add and not exclude other acute wounds, especially trauma wounds. Next slide, please.

97597 continues to be an area of controversy, in the coding community. 97597, I put the definition on the slide for everybody, is inclusive of debridement of biofilm slough, fibrin, and sharp selective debridement. Debridement of biofilm is not included in an office E and M visit but resides in 97597 from a coding perspective. It's important for the clinicians to understand that if, for example, they perform the surgical removal of muscle the previous week, and are now to debriding only devitalized tissue biofilm fibrin from a wound previously debrided, this procedure would be coded a 97597, not eleven zero four three because muscle tissue was not removed in this instance. There are no surgical removal codes for dermis and epidermis alone, the appropriate codes for both dermis and epidermis are 97597, 97598. And those codes are also typically used for recurrent wound debridements and they are not limited to any specialty to perform that service. Next slide, please.

The term sharp debridement is confusing in the field. Sharp debridement can be conservative sharp debridement and it's coded to 97597, scalpel scissors, and tweezers forceps may be used and only clearly identified necrotic tissue and devitalized tissue is removed. Sharp debridement is the removal of dead or foreign material just above the level of viable tissue and is performed in an office setting or at the patient's bedside, with or without the use of local anesthesia. Sharp debridement is less aggressive than surgical debridement, but it has the advantage of rapidly improving the healing conditions in the ulcer. These are typically the services for recurrent superficial or repeated wound care. Sharp debridement can also be a sharp surgical debridement, which could be coded to 11042 to 11047, and these codes are built according to the exact type of tissue removed from the wound. Sharp surgical debridement usually includes the removal of normal tissue, in addition to diseased tissue. Debridement is usually performed down to healthy bleeding tissue. It's extremely important for the documentation to distinguish between these two code sets. Blunt debridement is a removal of necrotic tissue by cleansing scraping chemical application, or wet to dry dressing technique may also involve the cleaning and dressing of smaller superficial lesions. Generally, this is not a skilled service and does not require the skills of a therapists, nurse, wound nurse, or wound continence ostomy nurse. Next slide, please.

For debridement, there's a concern because CPT, in the definition of those codes, abandoned the terms split thickness and partial thickness so, I would recommend replacing that with epidermis and dermis as per the CPT. Both the AMA and CMS agreed on that. When performing debridement of a single wound, you need to report the depth using the deepest level of tissue removed and in multiple wounds, some surface area of the wounds that are the same depth but do not combine wounds from different depths. I would say, consider saying that wounds are not coded individually. So, if somebody has ten wounds, you would not expect to see ten debridement codes. The consultation services rendered by a podiatrist in a skilled nursing facility are covered if the services are reasonable and necessary and do not come within any specific statutory exclusions. So, if a podiatrist performs a surgical service and the surgical service would be billed unless there is a distinct separately identifiable problem, other than the wound care that was treated. So, I would consider adding a clarifying statement there. For place of service 31, in skilled nursing facilities, podiatrists would bill the nursing facility and in place of service 32, the podiatrists would bill for the surgery and the skin substitute if appropriate, to Part B. Next slide.

Again, the proper use of modifier 25, this is another area of concern when it comes to debridement. If you note, I underlined one at the sentences, this is the Medicare, and the AMA.

Jocelyn Fernandez:
One minute remaining.

Donna Cartwright:
Thank you. If a minor surgical procedure is performed on a new patient, the same rules for reporting E and M services apply. The fact that the patient is new to the provider is not sufficient alone to justify reporting an E and M service on the same date of service as a minor surgical procedure. And CCI contains many, but not all, possible edits based on these principles. If the physician performs an unrelated significant and separately identifiable E and M service on the same date of service, they may report such service with an E and M with modifier 25. If the patient has had the wound reviewed weekly, there should never be an E and M added when a surgical procedure is performed unless there is an unrelated significant separately identifiable service. And the reason why I say that, is because with modifier 25, that's a major place that's audited on a routine basis. And many are clinicians are confused as to when they need to use the modifier 25 and when to use an E and M. A lot of times, E and M’s are used in addition to the minor surgical procedure and for clarity purposes, all wound care debridement procedures are between 0 and 10 global period days, which are considered minor procedures. Next slide.

And last but not least, the coding clarifications consider that all puncture, abrasion, laceration open wounds, operative wound complications and all trauma codes that are in the “S” and “T” ICD-10 codes should be added once it's decided if both acute and chronic are included in the LCD, the diagnosis code list should be revised. The current listing of diagnosis codes and the LCD is incomplete if the intent is to keep acute wounds in the LCD. The diagnosis codes should be added, for example, codes for open fractures, other surgical complications, such as lack of take or dislodgment of skin grafts complications of stomas, et cetera. And the current list diagnosis includes T31.33, burns involving 30 to 39% of the body surface, with 30 to 39% of third degree burns and if burns are excluded as stated in the policy, then why is this code included in the code list? I thank you for the opportunity to comment on the draft policy. And I will follow up. If any help is needed with the code list, I'm more than willing to provide once the clarity on the policy has been decided.

Thank you very much.

Dr. Larry Clark:
Thank you. Jocelyn. Thank you, for the detail there. We'll make sure we get it in writing.

Jocelyn Fernandez:
Our next commenter is Ms. Marcia Nusgart. Ms. Nusgart, your line is open.

Thank you so much. My name is Marsha Nusgart and I serve as the Executive Director for the Alliance of Wound Care Stakeholders. The alliance is a non-profit, multi-disciplinary trade association, of physician specialty societies, clinical and patient associations, whose mission is to promote evidence-based quality care, and access to products and services for people with chronic wounds. The foundation of the Alliance's work plan focuses on wound care research, wound care quality measures and reimbursement issues regarding coverage, coding, and payment.

We are pleased to speak today and want to thank the Noridian Medical directors and staff for working with us over the years and relying on us to serve as a resource to them.

The information contained in this draft LCD and policy article demonstrates you've been listening to our clinicians, and they’ve explained the complexity of treating patients with wounds. Particularly, we'd like to commend Noridian for including biofilm in this wound care LCD and acknowledging the central role that it plays in wound management.

Many of our association members, such as APMA and APTA, as well as clinicians and manufacturers who are integral to alliance activities, have already or will be speaking today on issues of importance to them. Our comments today contain both general and specific issues regarding the draft LCD and policy article. And we will definitely be providing more details in our written comments, and certainly, various evidence, if necessary since these issues are of great importance to our members.

So, when we reviewed the draft Wound Care LCD, it was apparent that Noridian, as Dr. Clark you already explained, utilized either the Novitas or First Coast’s policy as a framework with a few differences, but notably the language related to biofilm. Still the alliances convened many conference calls and prepared for our oral comments today, and our written comments later on.

So, the issues that our members kept highlighting focused on the language in the policy, since we know that words matter.

Thus, my comments focus on how Noridian can improve the policy article and the LCD by addressing five different categories. Outdated language, inconsistent language, clarifying terms, addressing inaccuracies in the policy, and add any incomplete information. So, I will be providing those in our written comments and many of them, but I'm just going to give you a few examples this afternoon.

First of all, replacing the outdated terminology. Throughout the LCD and policy article Noridian utilizes outdated technology, which has been updated by the AMA CPT Editorial panel, and can be found in the AMA CPT Code Book. These terms are no longer used as the result. And we would request that they be removed from the policy replaced with more current terminology. A few examples include partial and full thickness wound should instead be epidermis and dermis. Excised should be changed and replaced with the term removed. And in the low frequency non-contact section, the term sharp or excisional debridement should be replaced with selective or surgical debridement.

Second of all inconsistencies, with respect to wet to dry dressings Noridian seems to be inconsistent and at times contradictory, in some of the issues that they raised. Specifically, on page 11, the policy states one mechanical debridement method wet to dry dressings in which saline soaked gauze is placed on the wound and physically ripped off when dry is no longer considered for standard use, because it's non selective, may damage healing tissue and is very painful. So, right there you say that wet to dry dressings are no longer considered for standard use. And there realize that you're not consistent on the point throughout the LCD because, on page 9, point 17 states, “the following services are considered to be not reasonable and necessary, wound debridement services. Removal of necrotic tissue by cleansing or dry to dry or wet to dry dressing.”

And then, number 18 bullet point, it states “wet to dry dressings, jet hydrotherapy or wound irrigations should be used cautiously, as maceration surrounding tissue may hinder healing.”

So, in one bullet point, Noridian says the wet to dry dressings are not reasonable necessary then, wet to dry dressings should be used cautiously. So, this inconsistency should be resolved. And we'll make some recommendations in our written comments.

Third of all, clarifications. Terminology. Donna had already mentioned some of the terminology issues, but also, Emily Greenstein will address this issue more in detail. In her testimony, that's worthwhile to mention that Noridian, utilizes the terms, wound, ulcer, ulcerated skin, and skin ulcers interchangeably throughout the policy. We're not clear whether this was intended. We believe that these terms should be defined and used appropriately since the differences between these terms matter for both clinical reasons and for billing purposes.

Second of all, plan of care versus quote unquote, “comprehensive plan of care.”

So Noridian mentions the plan of care throughout the document, and even defines that a plan of care needs to include a comprehensive medical evaluation, vascular evaluation, and a metabolic nutritional evaluation. We have two concerns.

Number one, is Noridian requiring that all wound care patients need to have a vascular evaluation and a metabolic nutritional evaluation as part of its plan of care? And then the policy also states that a comprehensive plan of care is needed. It would be wonderful to understand what the difference is between a plan of care and a comprehensive plan of care. What's required for each. This information right now is not found in the LCD or policy article. So, if Noridian is making a distinction, then it needs to provide a definition of each of the terms.

And has already mentioned, by Kara Gainer, Noridian utilizes the term, skin replacement in the policy. The term skin replacement is most likely is an oversight. And we believe that Noridian again, meant to use the term cellular, and/or tissue-based products for skin wounds or CTP. So we would encourage Noridian to be able to use this term in its final policy.

Fourth inaccuracies, Noridian states that “if a clinician debrides biofilm, this service is part of the E and M code.” However, as Donna Cartwright already pointed out, and this bears repeating, debridement of biofilm is not included in office E and M visit but is included in the CPT Code 97597.

Then secondly, on page six of the policy, Noridian states, “Medicare would expect that wound care may be necessary for the following types of wounds.” And then it provides an example of open or closed wounds complicated by a necrotic tissue and/or eschar. A closed wound would be epithelialized so that eschar/necrosis would not be present in this case.

Incomplete information. We couldn't find it. Nowhere in the LCD does Noridian discuss total contact casting. We're not sure why Noridian had omitted TCC as it's considered the gold standard of care for treating a patient with a diabetic foot ulcer. Similarly, Noridian, [inaudible] the reference to Compression bandage Systems, which are the cornerstone of treating patients with venous insufficiency. We realize that those are covered in the DME policy, but we thought it might be advantageous to at least mention that this is how you would treat for compression.

There are other issues that others will be addressing today. They're also important to our members. Those are debridement, vascular surgery and palliative care. Just a note on the palliative care, we appreciate the recognition and acceptance of palliative care for wound care in this LCD, the alliance agreed that not all patients will heal.

Others today will address issues with documentation and specific language. We will add those in our written response, as well as additional coverage information about palliative care for your consideration, for inclusion in the final policy.

We, again, appreciate the opportunity to speak to you today and look to work with you in the future as you finalize this important LCD and policy article. Thank you so much.

Jocelyn Fernandez:
Thank you, Ms. Nusgart for your comments.

Our next commenter is Ms. Leah Amir and Dr. Thomas Serena.

Ms. Amir and Dr. Serena, your lines are open.

You may be on mute.

Leah Amir:
Hello, can you hear me now?

Jocelyn Fernandez:
Yes, I can.

Leah Amir:
Okay, presenting Dr. Thomas Serena, who is presenting on the MolecuLight Fluorescence Imaging System and the specific codes that are now Category three, but there's been quite a bit of utilization on 0598T and 0599T. Dr. Serena, would you like to continue?

Dr. Thomas Serena:
I would, thank you. Move to the next slide.

What we're talking about now is the MolecuLight procedure and I'm just going to go through it quickly. It's really a fascinating device. So, it shines a violet light on the, on the wound, this excites bacteria. And they in turn emit at, a light as well. And this can be detected by the device itself, and what it detects is a bacterial presence of greater than 10 to the fourth. That's the level at which a bacteria interfere with wound healing. And in the large clinical trial reference at the bottom of this slide, and we'll be obviously sending written notes in as well as requested. You note that that this has an accuracy that approaches 100%. Slide.

Leah Amir:
I've didn’t advance the slide.

Dr. Thomas Serena:
Okay, thank you Again, in multiple prospective clinical studies, you note that we have a very high sensitivity of 95% for detecting that level of bacteria that I mentioned before. You know, clinical signs and symptoms, as I'll show you shortly, they're not very good in chronic wounds. And the clinical signs and symptoms missed 85% of elevated levels of bacteria. But fluorescence imaging in the trial was four times better than clinical signs and symptoms and we'll have some bar graphs a little easier to read. So basically, what we're saying here is that this real-time evaluation of bacteria allows the clinician to make a decision at the point of care, and it's really essential because there isn't anything in the wound care.

Leah Amir:
Hello, I cannot hear Dr. Serena.

Dr. Larry Clark:
If you can pick up with the presentation while we try and reconnect him, feel free or to give your part while we try and get him back on.

Leah Amir:
Okay, I can, Let's see.

He does the clinical so well, because he's the doctor, and he knows what we're doing. I will, if it's okay, we can, we can advance to slide 11.

Continue. Next slide, please. Next slide.

I can start from this slide. So, we have clinical evidence that Dr. Serena was discussing that, is he back on?

Okay, can we go forward on the slides, please?

Dr. Thomas Serena:
I’m on. Sorry, I don't know what happened, but I was, I was looking, but I couldn't hear anything else.

Dr. Larry Clark:
Go back to the slide and we'll try and adjust your time.

Dr. Thomas Serena:
Thank you so much. We appreciate it. You can go to the next one. That's great.

Leah Amir:
Next one?

Dr. Thomas Serena:
Yep, one more. This is what we were talking about if you look at the lightly shaded bars there. That's how good looking at the wound and following what we were taught in medical school for clinical signs and symptoms of infection. It works great for acute wounds, but not chronic wounds. And you can see that the average sensitivity, there is about 15% for detecting clinically significant levels of bacteria. If you add fluorescence imaging to that, you get a sensitivity to seven times higher. And also, just as importantly, we have a couple of papers coming up. Clinical signs and symptoms would miss 85% of the wounds that had a heavy bacterial load. I recently published a paper on antibiotic stewardship, and you can't build an antibiotic stewardship program when clinical signs and symptoms when they only have 15% sensitivity detecting clinically significant bacteria. Next slide.

You know, one of the other things that’s really interesting about it. I want to add one more thing, and that is that, when you, when you take clinicians who are really good at it, and we've done thousands now, and, and you add onto that, your sensitivity gets even better. This makes sense, like any imaging procedure; the more you look at the images, the better you get. So, there is a, there is a learning curve associated with the device. But and that really helps you improve, even, novel use we still had terrific results. Next slide.

So, when you look at this, that the ability to see red fluorescence, is very good and you can see it detects at ten to the fourth ten to fifth and higher. And then for pseudomonas, which shows that the cyan color a white cyan, we're able to detect bacteria clinically significant levels in 90 to 100% of the study wounds in this case. Next slide.

So, you can see on this that there are areas of the wound that will show up on fluorescence.

And you can see down the bottom ones, there's the little areas where the arrows are, and what you see tells you where to debride. Now we've been talking about biofilm and this device will identify where bacteria is, and we believe that also in the biofilm core, it directs the wound clinician as to where to where to debride the wound, where to direct their topical antimicrobials. But as, as a surgeon and wound care specialist, I love the fact that I can now address my debridement to the area that I'm going to have to go after, and you can see that middle one, that area there. That's got to go. Okay, next slide.

So, right now, that we are flying blindly, to say the least. And you look at this, and you look at this patient and you say, well, this is one of my lady, she got hit by a car door about three weeks before I took this fluorescence imaging. And I would say, look, I don't see anything in that, that makes me think that there is any type of bacteria load there. If I was going to put a graft or another advanced modality, I wouldn't hesitate. Next slide.

What you see on the fluorescence imaging is, all that red fluorescence is, is bacteria at a very high level. And, you really, without this device, are flying blind in the wound clinic. And if I had to put a graft on this or they put negative pressure wound therapy on this, there's a high likelihood that those advanced therapies which come with a cost would not have been successful. Next slide.

So, in the flag trial, which is the trial that our major clinical trial, we found that fluorescence altered what the clinician was going to do in about 70%, 69 exactly, of wounds and that continues today. And I'm in the clinic right now, which is why I think we may have lost internet. But I'm going clinic right now and we're using it today and it continues to modify the way that we practice both in wound assessment, how we prepare the wound before putting on things like CTP's, antibiotic stewardship and debridement. Next slide.

So, this is really interesting is another analysis of the trial, you can look at a, a prescription of antimicrobials and non-antimicrobials. The prescriptions of antimicrobials in wound care at present is haphazard at best. That is just. There's no real rhyme or reason to how we, without resonance imaging how we are prescribing these types of agents. And, again, these are not without side effects, and they're not without cost. Next slide.

So, this is a great study that comes out of the UK and the National Health Service, just showing that over a two-year period where they used a device on over 200 wounds. What they found was that, what I just complained about, [inaudible] antimicrobial dressings, antiseptics went down by 49%. The patient's getting antibiotics, essential for antibiotic stewardship, 33% and healing rates went up correspondingly, and again, we have incorporated the MolecuLight device into our antibiotic stewardship program. This really shows you some strong evidence supporting the next slide. Leah?

Leah Amir:
Yes, this is an economic analysis we did by taking a clinical trial data from randomized controlled studies where the bias was extremely well controlled, both in the National Health Service, as well as for the flag trial that Dr. Serena mentioned. And we did an analysis only of Medicare Part B expenditures of physician work, associated with wound care. And additionally, added the reduction in laboratory testing when the fluorescence image gives us cyan, we have a 98% probability or greater that we're definitely looking at pseudomonas and they know how to treat that on the spot. As well as when the image is red, we know that we have pathogens in a wound that need to be treated and appropriately rather than guesswork. So, taking that information together, if we add all this up was about 144 million cost savings to the Medicare Part B system just because of accurate information at the time of care and removing guess.

Quite honestly, looking at this, seeing bacteria, just, we showed where otherwise you wouldn't have seen it is completely transforming the treatment of wounds. Next slide, please.

So what we're requesting is a coverage relative to the January 12th CMS indication, where medical necessity and reasonableness are identified and with the studies that have been done with this degree of statistical significance that we have demonstrated that this added information is changing treatment plans and bringing wounds to closure. We are requesting that in portable points of service of 11, 12, 31 or 32 and 33, 34, meaning doctors are taking this portable imaging system into the point of care where they need to see the patient. With COVID this has become absolutely critical. There are doctors, I know, in the South, as surgeons who when COVID started, grabbed this machine, took it with them, and started taking care of their patients who had no ability to get to any kind of an acute care setting. So, this is all about improving patient outcomes, reducing their pain and suffering. Next slide, please?

Just in summary, it's the clinical information that has led to the utilization of this product.

It's led to the transmittals that allow reimbursement for these codes in an ambulatory surgical setting, and ambulatory or excuse me, hospital outpatient setting and some of the doctors have already seen on their own that they're saving tremendous cost when they have to buy these CTP's or skin substitutes as well as having the information about the presence or absence of bacteria is absolutely in line with the National Coverage Determination for wound care. Next slide, please.

I thought it was appropriate to leave you with this particular image rather than wonder why a graph failed or know if it will fail. This is a little bit of insurance, you can have to know that indeed, under the fluorescence image, we can see that this particular graph is completely full of bacteria both pseudomonas and some of the other proteus type organisms that you'll find on a wound. And thank you and we're happy to take questions.

Jocelyn Fernandez:
Thank you, Ms. Amir, and Dr. Serena, for your comment.

Dr. Clark, did you have any comments?

Dr. Larry Clark:
I just wanted, and then I'll ask Dr. Capehart if she has any one of the things that struck me there was a slide where you talked about the implications or comparison, relative ineffectiveness of routine culture and sensitivity guided antimicrobial stewardship. Would you be kind enough when you submit your write up of today, if you would specifically address the additional benefits or the implications? I think you had a number there like about 15% efficacy in the culture and sensitivity guided antimicrobial stewardship. So, if you would do that, I would appreciate it. Dr. Capehart.

Leah Amir:
Thank you, Dr. Clark. We will.

Dr. Raeann Capehart:
One of the things, this is Dr. Raeann Capehart. One of the things that I had some questions about in the early data. Oh, you said that this shows a bacterial count of, greater than 10 to the fourth or 10 to the fifth? Again, my question is more traditionally, we have said greater than 10 to the fifth of cubic centimeter of tissue. It appears to me that your data is based on surface area, do you have any idea of the depth penetrance of the evaluation?

Dr. Thomas Serena:
So, when we did the trial, we, actually took two millimeter biopsy, so was it really surface. It went down, as far as the device can visualize, and that's about a millimeter. If I said centimeter before I meant millimeter. But it's about a millimeter with biopsies, were cut at two millimeters. So, we were obtaining more than surface. You know, most of the literature, and we've done extensive reviews, shows that healing is inhibited at 10 to the fourth, or greater. And that you begin to have problems with grafting at 10 to the fifth. But I will tell you, in the final analysis, it didn't really matter the same, there wasn't a big change in sensitivity. There was no change in prescription of antimicrobials, antibiotics, or topical of any kind on the part of the clinicians, whether you attended the fourth or 10 to the fifth, or even ten to six, to be very frank.

Dr. Raeann Capehart:
Have you looked at the colony count, before and after standard, oh let’s just say washing with soap, and water. Have you gauged the reduction?

Dr. Thomas Serena:
Yes, and actually. [inaudible]

Dr. Raeann Capehart:
Go ahead.

Dr. Thomas Serena:
I'm sorry. Soap and water doesn't do a whole lot. We've been shocked by how some of the treatments that we thought worked, don’t. There are some, we just finished a clinical trial, it's not published yet, in which we used a topical antiseptic, and it does reduce bacterial burden. Debridement reduces bacterial burden, but interesting enough, again, it doesn't completely eliminate it on one debridement. You need to do weekly debridements for 3 to 4 weeks.

Dr. Raeann Capehart:
Have you evaluated with, perhaps the Misonix or, you know, the old-fashioned was the standard water pick debridement or device, similar? Have you had any difference when you're actually is a not particularly sharp but fairly aggressive debridement mechanism used?

Dr. Thomas Serena:
We haven't done studies with the, with the Misonix type device yet. I mean, a lot of these are trials are ongoing. I think we’re about 2 or 3, 3 or 4 of these trials just ongoing. So, I don't have any data for you. The only two I have are; one is debridement, in combination with an antibiofilm agent, which actually was just published this month, and then we have another one where we did just an antiseptic with debridement. And in both of those demonstrated reduction in bacteria over four weeks.

Leah Amir:
So, you ask an excellent question. When one is doing a debridement or a cleansing, you actually can see how effective you are. So, it doesn't which you select. We are now understanding with great clarity and immediate information, which is actually effective against the region of the bacteria. And that is where doctors frequently say, I am humbled by this information every day because you were blind and now you have an image.

Dr. Raeann Capehart:
That leads to my next question. How often would you recommend, study a wound before and after therapy, weekly, daily? Every time the wound is debrided or dressing change, or just a matter of looking at trends.

Dr. Thomas Serena:
So I can share my recommendations, I just gave a recommendation to all of our centers in the Serena group family, and my recommendation is new patients, patients that have failed to heal by 30% in four weeks, and if a patient is positive, then re-image it 2 and 4 weeks to make sure that you've eliminated the bacterial burden and that's our current recommendations for use. I don't want I don't think I don't think clinicians should be using this every day or anything like that, with that kind of frequency. I think there's, you know, we've come up with our own guidelines, and we have we've assembled a consensus panel that will be doing a Delphi process.

And we'll publish that, probably, next, in the next few weeks, on exactly how it should be used. But that's what I've shared with you, is the guidelines that I've given to my group.

Dr. Raeann Capehart:
I think, I think, I understand that. In other words, if a wound gives cause for suspicion, in other words, not responding to the standard of care, whatever, your standard care may be at the time.

If it doesn’t progress as expected, that will be an indication for evaluation?

Dr. Thomas Serena:
Absolutely. It's exactly right.

Dr. Raeann Capehart:
I don't have any other questions. Thank you.

Jocelyn Fernandez:
Thank you for that.

Our next commenter is Ms. Stephanie Woelfel.

Ms. Woelfel, your line is open.

Stephanie Woelfel:
Thank you.

I appreciate the opportunity to be able to speak today. My name is Stephanie Woelfel, I’m a Doctor of Physical Therapy and a Certified Wound Specialist. I am a member of the American Physical Therapy Association, And I'm also an Assistant Professor of Physical Therapy and Surgery at the University of Southern California. And today what I want to speak very specifically about in regards to the LCD and some of the terminology is low frequency ultrasound. Next slide, please.

So, I think the issue at hand, and it's important to know that, this Noridian draft LCD is not the first time that that this issue has come up. But I think it's a great opportunity for us to maybe clarify some things that have been kind of mashed together over time, but low frequency ultrasound devices differ in how they deliver their ultrasound energy and that creates significantly different effects on the wound bed. Now oftentimes low frequency ultrasound is lumped together. You see low frequency ultrasound discussed versus high frequency ultrasound, for example, but there's really two completely different mechanisms of action and two completely different categories within low frequency ultrasound and those would be the non-contact method of delivery versus the contact method of delivery. Next slide please.

So just to give an image here, this is an example of low frequency, non-contact and because of the fact that it's non-contact, this is also considered non thermal ultrasound. So, kind of the primary differentiator here is that the applicator that is delivering the ultrasound energy does not touch the wound bed. Therefore, the non-contact definition. The ultrasound energy does stimulate the wound bed at a cellular level, and you will see a decrease in the necrotic tissue over time with use of this device. But it is really not what would be considered an active debridement and that is part of the reason that it was determined to be eligible for its own CPT code and is covered under CPT 97610. Next slide please.

This is just an example of a patient that received non-contact ultrasound and kind of what their progression looks like, so the photo on the left is the initial photograph of the wound. The one on the right is following five non-contact ultrasound treatments and the duration of those treatments are based on the wound size, so for the size of this wound for example, each treatment was about eight minutes in length. So, the thing I just want to point out here is that you can definitely see the wound edges in the margins that we're seeing more red, healthier, looking granulation tissue develop. But considering this is five treatments later, this is not something that I would consider providing aggressive debridement. And I just want to then contrast this with contact ultrasound. So next slide please.

So low frequency contact ultrasound is where the applicator actually comes in direct contact with the wound bed. And the ultrasound energy creates immediate and visible debridement of necrotic tissue right at that point of service. And when you're using these devices, you are reimbursed using the debridement codes based on the level of tissue removed. So, for physicians using some of these devices in the OR, that could be the eleven thousand series code for physical therapists that are using some of these in an outpatient, or even perhaps an acute hospital setting. This would be the 97597, 97598 codes. Next slide. Next slide, please.

Okay, Thank you. So, here's an example.

Sorry you can go back to the photos. Another example of contact ultrasound progression. So, on the left, again, is the initial wound photo, and then on the right we see the after, and this is following just wound four-minute contact ultrasound treatment. So, it's really, really. [silence]

Next slide, please.

So I really think the opportunity and my ask and I will follow up with this definitely with the written comments is that I think Noridian has the opportunity within this LCD to correctly identify and define low frequency ultrasound using contact versus non-contact so that we're getting the appropriate care to our patients. So, I thank you very much for the opportunity to speak today.

Jocelyn Fernandez:
Thank you, Ms. Woelfel, for your comments.

Our next commenter is Dr. Sean Brimacombe. Dr. Brimacombe, your line is open.

Dr. Sean Brimacombe:
Hi there, can you hear me?

Jocelyn Fernandez:
Yes, I can.

Dr. Sean Brimacombe:
You’re good, I’m good?

Jocelyn Fernandez:
You're good.

Dr. Sean Brimacombe:
All right, I don't have a nice formal presentation like everybody else, but I am an orthopedic surgeon in Arizona and I just have a couple of general comments I guess about wound care.

I think the coverage guidelines are nice, and they show how complex wound care really is in terms of all the comorbidities that go into that we actually have to consider whereas a lot of specialties, they may note the comorbidities but don't necessarily treat them. This is something that we've been fighting with, with our own billers about how complex these treatments are.

So, I recognize that the guidelines see that in terms of understanding vascular flow, nutritional status, diabetes offloading pressures, but I think there's kind of a disconnect when it comes to billing, coding, CPT codes. For example, and it's been talked about the idea that a subcutaneous debridement of 11042, that maybe should be limited to a couple of debridements. Especially in the face of biofilm of getting down into the subcutaneous tissue is actually very pro healing.

Starting a healing cascade, eliminating biofilm, which is actually can be down into the subcutaneous tissue, not just on top of a wound. But, in Arizona, for a facility, charge for 11042 that pays $59. But, if I did a level three visit, 213, it pays $66. So, the idea that our procedure codes include our E and M is appalling to me. I'm an orthopedic surgeon, most surgeries, that is the definitive treatment. So, you do a surgery, you closed it up your treatment of the problem is done taking a dressing at that point for a closed wound and wound care, my job is halfway done by the time I finish the debridement. The whole decision for wound management now have to start over from every patient characteristic from being able to offload, to how frequently can they do, a dressing, do they have help at home, can they reach their wound, do they need home health, much less all the other comorbidities, nutritional status, diabetes weight bearing. So, the idea that the CPT codes for procedures include the bulk hair for an E and M code, I don't think is appropriate.

Number 2, one of the big things we have to deal with, with our patients is nutrition and diabetes.

And I'm curious as to how that's going to be measured. I mean, unless I'm actually managing their diabetes, if I'm referring these out, these may get followed with A1C levels. At best every three months. So it's kind of hard to document significant improvement if being referred out to an endocrinologists, for example, in addition, getting people into nutritionists and dieticians can be a work of God or an act of God to get them in often times. A lot of times they're not covered. The services getting them referred into there is very difficult. So, either we're being expected now to be diabetic experts, nutritional experts, wound care experts, offloading expert, surgical expert, or we need some sort of guidance as far as what that means to manage their nutrition and diabetes.

Specifically, there was comments about calloused carrying only being for symptomatic wounds or symptomatic callous lesions. Quite frankly, I don't know what that means when most of my patients are diabetic and neuropathic. These are pre ulcerative problems that lead to ulcerations, they're not usually symptomatic until they have the ulcer. They don't have pain. So, the idea that callous pairing for an asymptomatic ulcer wouldn't be covered, doesn't quite make sense. I think some of the documentation requirements, especially for procedure notes, are probably more excessive than most surgery notes I read from people getting full surgeries from knee replacement to shoulder scopes in an operating room.

There's also the idea that with a debridement, we should send anything below subcutaneous tissue to pathology. So, anything involving tendon, muscle, bone, that seems like, you know, if you're worried about infection, I certainly think that’s reasonable. But to send every debridement, every week that may involve a tendon, or a bone is probably a waste of resources.

And, I think, based on a couple of talks with Dr. Serena, the biofilm is an issue, and how it's included in an E and M, but then we need to debride it, but it's only debridement of selective debridement. It just really, it really doesn't make sense. Biofilm is a big problem. Maybe we're getting techniques to find it. But this is why we do big debridement to try to change a chronic wound into an acute wound.

I second all the comments about wounds versus ulcers versus acute versus traumatic versus chronic that. I don't know that distinguishing all of those helps anything, just their wounds and they all need care. I do think that the idea that there’s certain limitations on the number of debridement is short sighted. Yes, if you have a wound that is healing and going according to a normal pathway that you would want to get to heal, then certainly your number of debridements are going to be limited over time. As anybody in wound care knows, those are our easy patients. The majority of what we see are the difficult patients, that's why they're in the wound care clinic and they don't follow normal healing pathways all the time. For whatever reason, just, as the LCDs suggests, there's multiple reasons for poor healing. And to remove pathologic tissue is often quite important and not necessarily a factor being done four times in a month or twelve times in a year or whatever the numbers may come up with. So, to put a cap on that really discounts the severity of our patients and the inability to really manage them long term if we're having to count the number of times, we're doing something, especially on a very difficult patients. Most of these patients are not the perfect patient or they wouldn't be on the wound clinic. They're unhealthy. They're often less than compliant or unable to be fully compliant with what we ask them to do. So, to put the handcuffs on us in terms of regulating based on a certain number of debridements based on what should happen with a wound is just unfair.

That's my 10 minutes.

Jocelyn Fernandez:
Thank you, Dr. Brimacombe for your comments.

Dr. Clark, did you have any comments?

Dr. Larry Clark:
No, I just want to say thank you know. I do want to say that both Dr. Capehart and I, in our own specialties, have, I don't know, I think aggregate of about 50 years of clinical practice and share a lot of those sensitivities. I think the policy has worked in the fact that it, brought you out to speak today. And I think there is just a general concept that we're trying to get is what you said. People generally don't get non-healing wounds because they're healthy. And one of the problems we have been seeing in our jurisdictions is a disjoint between the management of their general health and these comorbidities and the wound care process. So, we are hitting that sensitive point for a reason as a reminder. And your comments are appreciated. And I asked you, particularly if you would commit them to writing, unfortunately, people make some very good presentations, and then they don't follow them up in writing. So, we would appreciate your comments in writing, and I will ask Dr. Capehart to take a look at the callous and pairing language came out of, as I mentioned, we retired a policy and rolled it in, so we will take a look at that language. So, thank you very much.

Dr. Sean Brimacombe:
Okay, thank you.

Dr. Larry Clark:
Dr. Capehart anything on it?

Dr. Raeann Capehart:
No, I'm happy to echo what Dr. Clark has just said I think, it’s certainly incredible value to him, [pause]a clinician, who actually deals with the wounds, not from a peripheral point of view and not as a point of business.. To give us some alignment as far as what really works in terms managing these things that become chronic wounds.

Dr. Sean Brimacombe:
Are there opportunities for offline discussions?

Dr. Larry Clark:
I think if you send in the written comments with a request, to review your comments, I think that can be arranged. That's the way I would do it.

Dr. Sean Brimacombe:
Okay. That sounds great. Thank you.

Jocelyn Fernandez:
Thank you for your comments.

Our next commenter is Dr. William Tettlebach. Dr. Tettlebach, your line is open.

Dr. William Tettlebach:
Yes, so I just want to make sure that you can hear me, is that, you can hear me fine.

Jocelyn Fernandez:
Yes. I can hear you. You’re good.

Dr. William Tettlebach:
Alright. Good. Alright, perfect. So, yes, just a little bit about my background. I’m an infectious disease doctor who got into wound care about 20 years ago and have trained fellows over the years and both hyperbaric and wound and still actively in clinics and do an inpatient and outpatient. And have a broad, you know, other array of exposures. You know, in going over this. I think I'm going to re-iterate, so it's nice to hear some of the same comments, because I think everyone's hitting the same ideas. And, you know, we've had tools that presented that could address those ideas and then just basically the concepts that needs to be, I think massaged in this LCD and I agree that this is a great start. So, what are the things right off the bat is the whole concept of the pathology. I total agreement. I put in you know, it's in writing on this on the slide. I don't know, I can't see my slides, but I don't know if you're showing them.

Rachel Broer:
Yes, we're showing them we have slide one up.

Dr. William Tettlebach:
Alright, so I'm just looking at my own, and I can't see them, but I will go. So, basically, I agree. You know, if you're basically just trying to send something for sustaining or validating the level of debridement of a, you know, deep tissue or deep structure debridement, then this is really an extravagant cost in my mind. Because you're not necessarily looking for data and you might actually get data you know like, there's the whole saying that more, too much information can mislead you just as much as not enough information. So, you know, that's part of we try to do evidence-based but work build upon our experience. And the more you see, you know, the more that you see atypical presentations, the more common they become to you because you start recognizing them. But the thing is you have to think about the patients who have co-pays. And deductibles this is an expensive way of validation, so I think this really one area should be left to the discretion of the treating physician. I agree that, with 30 days of failure to heal, or if people aren't familiar with like pyoderma, or things like that, we underutilized biopsies and pathology so that, you know, could be built into the language somehow. But I think, you know, this is been stated more than once now and you'll hear it again. That I think using it as a validating system maybe the wrong first step for this LCD. So, the next, next slide.

And then this, you know, basically, you have statements in here, and these are, you know according to the proposed Wound Care LCD, and actually, the draft article I touched on as well, just for alignment, but the thing is, is when you, as Thomas stated, and everyone else's stated, you know, when you are, debridement is considered unreasonable and unnecessary, if a wound is clean and free of Necrotic slough. Well, if that wound is stalled and, you cannot visualize the biofilm by the naked eye. And as Tom said, you know, that, you know, 10 to the fourth is considered, you know, sort of this critical colonization of terminology we've sort of gotten rid of, you know, not gotten rid of but away from and thinking more of early infection of the wound or the, you know, it's really all about inflammation. So, you still got to get rid of that inflammation.

I think that's a statement that just could be removed, you know, because the rest of that section on the limitations has, you know, I think, good language in it. Other things that need to be considered and tweaked that a lot of this the LCD I think, works really well at hospital-based systems, HOPD clinics, well run centers, standalone centers, you know, there's multi-specialty clinics. You know, I think Jeff does, you know, Ms. Nusgart has a great example of that, but these folks, you know, the PT folks who are out in rural areas or critical access areas, or, docs, who are kind of on their own. You know, when you order these, these tests, they like the vascular workup and the venous, the vascular I think we need. And I think it actually should be part of this. But giving you a two week, run in period to get it sometimes, I think, may be unreasonable when there's transportation issues. There's, when you're making appointments, it could be literally two weeks out, or this individual is going to have to drive to another center, or ways away. In some cases, spend the night and then they got to arrange everything, or get family. You know, maybe we just need to make sure it's documented or within the 30 days, or at least, it's been thought of. But, you know, it may be too short of a time period, if you try. Make this an umbrella, coverage for all areas. And then, you know, there's, in this section of limitations on page nine, I think, of the proposal, section 25. You know, basically, if there's failure document improvements, ensuring 30 days, there's this, there is this language thing about transitioning to alternative care, alternative care setting, such as a multi-disciplinary or specialized wound center, you know, with COVID and everything that has worked and easily. And actually, a year before this pandemic actually brought to that PTAC committee and there were proposals or, you know, letting say, PT wound physical therapists in rural and critical access areas actually use more advanced techniques. But the, the input I was giving at that point and actually had a one-on-one with the senator, the CMMI committee, was that we needed to bring telehealth and have someone you know, who can give or get guidance on the next steps that they have, not may be in their mindset. So, I think really telehealth needs to be integrated into this area where there's failure to document it, [pause] progression, because, we have to think about this. You know, in these areas, there's a lot of multi-specialty teams, and in the urban areas, or are these multi-specialty clinics. But when you get into rural areas, and these patients have to drive, you know, an hour, two hours, one direction an hour, two hours next direction every week. This is a heavy burden.

I think this is where we can, you know, integrate, you know, telehealth and you know, getting these spoken like, you know, there's folks that are developed. There’re companies that do this. But, at Inter Mountain, we developed years ago a [inaudible] model where there was a waterfall. There was always someone to take a call when a call came in, it didn't have to be a network. So, you know, these are things that can happen, and I think people can take on, especially with the coding that's been available or made available and hopefully will be made more permanent. Next slide.

So, this is, you know, I think just for the sake of getting it right within the LCD. And when you're talking about active wound care and this was mentioned you know, just in the last, I think hinted towards in the last discussion where, a lot, you know, your debridement may be categorized as selective or non-selective. But yet, there’s surgical, which is more, you know, we don't use an excisional in the LCD itself or other chapters of the reimbursement. But, there's surgical. And so, there's really three levels there, surgical selective and [silence]. I think we need to put that in there and it needs to be clarified so that aligns both with the article as well as the LCD here. And then, also, in this, there's mention of the use of E and M’s in conjunction with surgical debridements. And it would actually on page seven, it would be helpful to put in this section the fact that you would use a 25 modifier when there was clearly a separate and identifiable problem that was being addressed that day. So, it's like a new infection, or maybe you put someone on C diff and if you didn't have the fluorescent light, you had them, you know, inappropriately and they got that as a result. Now, you got to work that up. That's a new problem that's an E&M that would be billed on top of doing your doing your debridement that day and I think it would help get the billing right, and actually the Medicare claims data that needs to be studied, right when these modifiers are put on to try to pick up complications that are occurring maybe during these episodes of wound care so, that's data, I think in the future, if we do this right, can be very helpful.

Then, next slide. Talking about definitions and terms. When advanced dressings is noted here, is basically saying used with increasing frequency to provide general debridement and treatment of acute wounds. But, advanced words don't always give debridement, you know, they basically, for provide a protective environment, I think we just need to get the terminology right, people are going to read this as well, and be educated by it. So, there's a component of education that has to be right when we, when we talk about this. So really, I'm kind of going through what I think is more critical to less critical. And again, in the background in history, I think there's a couple things. One thing is that when you're talking about history and background, we don't mention moisture control at all, in the, in the treatment plan. So, I think that needs to be inserted into that. And again, there's the fact that we need to make sure that we put surgical into the selected and non-selective terminology. And then also, I think even when you're talking about the causes, you know, there's metabolic physiological, there's the nature of the wound or the complicating. But there's also iatrogenic causes that are being caused by what is being given to the patient that needs to be worked up at times. And so, I think that's a terminology that needs to be put in there. Then, when, next slide, please.

So, the next one, actually talks about surgical debridement. And I think there just needs to be clarification here when you are billing your square centimeters or your area of debridement and you put down your initial, say, it's a surgical debridement and you put a 11042 down, then it's more than that. Say it’s an extra 80 square centimeters or 60 square centimeters that’s when you put the quantity on. So that’s, you know, the add-ons are where the quantity. In the statement you’re saying it’s up to four units but is that truly four units because I remember the cut off was 100 square centimeters. Now that would sort of imply it’s 80 square centimeters and so there’s been a reduction or is it actually the original less than 20 square centimeters plus 4 units. I think that needs to be clarified and if it is 80, that means there’s been a reduction and I don’t know why that’s happened or maybe I just misunderstood this all these years and the feedback on that would be, would be helpful. So then, you know, there's the EM codes in the… I’m switching over now to the draft article of debridement where it actually states EM codes are not usually build a conjunction with the debridement. I think this is somewhat of a misleading statement, where it's maybe it should say, EM codes are you know, billed and, you know, specific or only and only in very specific situations, you know, when a procedure, when a surgical debridement is. And then you sort of clarify that. Like, I think the initial workup includes an EM because that's a broad work up. You're working up everything to make sure, you know, you'll get a diagnosis, what you're treating, and then you have the procedure that you have to do that day as well, if the patient's ready for that. But then also, as I mentioned before, there's new issues that pop up, that have to be addressed. And again, there’s, you know, this is where you might want to state a 25 modifier. I think actually the next slide, there's a table on page nine within the draft article that gives you a 59 modifier and all these other modifiers, but the 25 modifier’s missing and I think it needs to be in that table.

And so, getting close to the end here. I think, you know, in the draft article, there's the minority of beneficiaries, this was stated in the last discussion, where there's a limitation on of 12 surgical debridements or 12 weeks, one debridement in a week and in a 360 day period this. There have been other MACs in the past that have put limitations on debridements, and it really didn't work well, and they got rid of it. There's not a lot of data to support the limitations. I realize the studies that are mostly done are done on a 12 week, you know, basis with a 16 week follow-up.

But the thing is, is in the real-world of wound care, you may get you get great progression and be almost there at 12 weeks, or 12, debridements sub Q wise, and really, you know, you're going down to selective, you're trying to do sort of this step down, step up, model that Randy Wolcott and Greg Schultz and the Global Committee were a part of. And you should be going down to less aggressive debridements but you know, there's so many things that happened to these patients, you know, they could have an exacerbation of their CHF and they have swelling and it's going and the wound is going to break open and get and they're going to, they're going to miss you know, a couple of clinics and you may have gone through that 12 and got it close to healing.

Jocelyn Fernandez:
One minute remaining.

Dr. William Tettlebach:
So that's, you know, that's something that needs to be modified because there needs to be modifiers on that. And then the last one is really, you know, looking at casting. There's language missing in here. Let me just go 1 or 2 minutes over. The thing about casting is that we know that that's effective. But when it's bundled into a debridement code or bundled into an advanced therapy, there's, there's a time issue. And a lot of docs, unfortunately, the real-world will either ask the patients to come back, which is the burden on the patient, and the healthcare system actually may cost more because they're doing this outside of the initial procedure that's bundled.

But, I think if you add something in-between where it was actually a new code that included both of, you know, if you did, the debridement, put a cast on or if you did an advanced therapy application and put a cast on there would be bundled payment that would encourage folks to do that instead of putting on a walking boot. You know, we know people who get walking boots don't wear them most of the time or trying to modify post op shoe is just half halfway there. So, I think to get the optimal care, we need, that needs to somehow be considered and addressed in this new Wound LCD. And that's it. Thanks.

Jocelyn Fernandez:
Thank you, Dr. Tettlebach for your comments.

Our next commenter-

Dr. Larry Clark:
I want to say thank you too, Dr. Tettlebach among others, Ms. Calves, Ms. Woelfel, and others. Many of the folks that are on today or a number of them, contributed to the CAC where we reviewed and discussed literature and sort of help prioritize where we were going the first part of policy development in the 21st Century Cures process. But I just want to also say, thank you, because I really appreciate, in terms of the best practice. If you'll notice, the way, he actually addressed on the slides, the language in the policy. So, when we go back, we can match up the points from today, his written comments, and those slides so we can go directly to the areas of question or controversy so thanks very much and go ahead Jocelyn.

Jocelyn Fernandez:
Our next commenter is Dr. Kenneth Anaeme.

Dr. Anaeme, your line is open.

Dr. Kenneth Anaeme:
Thank you very much. Can you hear me?

Dr. Larry Clark:
We can hear you, sir.

Jocelyn Fernandez:
I can hear you.

Dr. Kenneth Anaeme:
All right. Thank you. So, yes, my name is Dr. Anaeme I work in Arizona. I am a wound care practitioner. I've been practicing wound care since two thousand and five. I work in various settings, including the Hospital Outpatient Department. I also have a couple of private wound care clinics that I own in my private office. I work in the Skilled Nursing Facility Unit in the hospital, so I think I'm quite familiar with the gamut of wound care presentations.

I would not like to [inaudible] at the risk of sounding repetitious will make some of the same comments that have been made before, but I just felt that it was important to make them. I had prepared these comments before all the other speakers that are speaking. I wish to make them, even though you might have heard them before.

I, I believe the point of the LCD is really the appropriate utilization of resources and streamlining care but listening to reading the LCD and also listening to some of the commentary. I am becoming more concerned that it's almost created, a wound care training curriculum or a clinical practice guideline, which I think strayed from what the LCD should be. So, I think we should really, and there are few areas of concern that I have. And I think we should go back and address that in the LCD so that we don't end up moving into areas that will be more appropriately spent by clinicians or [inaudible] researchers are developing empirical direct evidence.

Specifically, if we look at the page four of the LCD where it talks about the management of acute wounds or the statement before it says for the purposes of the LCD, wound care is defined as care of wounds that are refractory to healing or have complicated healing cycles. That is, that is correct. But it says now that the definition excludes the following the management of acute wounds. So, we all know in wound care, that an acute wound is one that healed in a sequential order of healing from trauma to bleeding to hemostasis to inflammation proliferation and maturation of the wound. The timeliness of the wound of the healing is not the issue, it is follow-up progress. So, I think, it would be a mistake to remove acute wound because an acute wound could heal in a sequential fashion, [inaudible] actually prolonged in time and needs expert follow-up. So, I believe that statement management of acute wounds should really be struck from that LCD. Because what we really are treating are complicated wounds. It doesn't matter whether they are acute or chronic. So, I would recommend that that statement be struck from that LCD.

Moving on to the next one, page five of seven, page number five, again, there's an accurate statement there on wound debridement. The appropriate interval and frequency of debridement depends on the individual clinical characteristics of the patient and the extent of the wound; that we all can agree on. However, that statement is that unfortunately subverted by subsequent statement of [inaudible] the LCD. If we go to page seven, of the LCD, which a lot of people have brought up, it says that debridement is not considered medically reasonable and necessary to be a wound, that is clean and free of necrotic tissue and slough. So, obviously have many speakers have brought up that Biofilm is not visible to the naked eye, and in my general practice, of wound care over the years, I teach my residents whom I come in contact with that the single most important thing they can do for a wound every week is to take a curette or scalpel to that wound and clean out that wound and convert it back into acute wound that will begin to jump start that process of natural healing.

So, I think the two statement are incompatible, and I think that statement number two on limitations should really be removed from this LCD because it imposes such a burden on us, as wound care practitioners, to say that we’re not going to be able to debride a wound that is free of necrotic tissue. We do not see biofilm when examining the wound so we cannot tell, I mean, I appreciate Dr. Serena’s presentation; however, I practiced mostly in the trenches in an outpatient wound care facility, as well as in my private clinic, and I don't have access to these kinds of methodologies and I will not have access to them anytime in the near future.

If I move on to page number eight, statement number eight, as well, and talks about the debridement, of [inaudible] as not being appropriate [inaudible]. Again, I think that is a very clinical statement and I don't really think it does any purpose, other than, again, restrictive and defining what physicians can and cannot do when they're faced with a clinical situation. I don't really see any need for that statement to be done. I would recommend that that statement should be removed.

Also, statement number nine, we talked about surgical debridement to be considered not reasonable and necessary when documentation indicates the wound is without devitalized tissue [inaudible] a repetition of what was previously said. Again, I would recommend that that situation be removed.

Moving on quickly to page number nine, the line number 25 again, was mentioned by the previous speaker. Talking about failure to document the progress of the wound healing over 30 days [inaudible] transition to a multidisciplinary and specialized wound centers. It kind of brings up a question, then, what was this LCD or who was the target of this LCD. I assumed it was, the target was for wound care physicians. People who specialized in wound care. It almost seemed like it was directed toward the primary care physician, and who should then, after 30 days, refer the patient to the wound care center. I mean, I'm not sure if I’m mistaken or, because that statement. I can't believe reconcile it with what the purpose of the LCD was. I think it really shouldn't be there but I’m finding it hard to understand what it’s referring to. But I assume that we're talking about specialized wound care centers all along.

Specialized centers could be in a free-standing clinic like mine is. I have two free-standing clinics and we perform all forms of wound treatments, including debridements, we put on negative pressure wound therapy. We TCC casts. We do vascular ultrasounds in my clinic, including arterial and venous ultrasounds. So, we do everything that can be done in a hospital outpatient care center. So, I think, to have that statement is not needed.

Now moving on, to the final comment that I have, which is the limitations that are imposed on or by this LCD, [inaudible] somebody has spoken on one of them, which is also utilizing the, debridement below subcutaneous tissue [inaudible] a biopsy in order to validate that debridement. I think that would be really counter to what we are trying to achieve, which is appropriate utilization of resources.

We do provide many debridements to free, up necrotic muscle and perhaps necrotic bone and we don't necessarily have to send the biopsy all the time, perhaps on the initial debridement to culture that specimen but subsequently, you don't need that. So, I think that would be an unnecessary waste of resources.

And then the second, and probably the most important one is the limitation on providing only 12 debridements in a 360-period for wounds. Depending on where you practice, the wound care patients whom you encounter would be very, very different.

I have a practice in a very affluent area of a Phoenix suburbs where most of my wound patients typically falls and scrapes and lacerations and those patients are usually healed up within that 12-week period. I also have a practice in the inner city where these are very high-risk diabetic patients with large, complex wounds. I can tell you that in normal wound healing process with weekly debridements for these patients would probably be in the order of 4 to 6 months and that will be considered acceptable and quite reasonable. So, I think this would effectively tie our hands in terms of what we can do for patients if we actually kept that recommendation to limit the debridements to only 12 in a 360-day period.

I'm not against the four in 30- day, because usually most patients I evaluated weekly. So that would be reasonable to keep that in there. But I certainly think that that the [inaudible] of 12 in 360 days should be struck from this LCD.

I will be putting all of this in a verbal recommendation and the original recommendation and I’m glad that option is provided to us and I wouldn't go any further and I thank you for listening to me.

Jocelyn Fernandez:
Thank you Dr. Anaeme for your comments.

Our next commenter is Ms. Judith Madura. Ms. Madura, your line is open.

Judith Madura:
Hi, are you able to hear me?

Jocelyn Fernandez:
Yes, I can.

Ms. Judith Madura:
Okay, thank you, and some of the comments I was going to make have already been addressed, so, I'm just going to focus on the proposed LCD, number 23. And Dr. Brimacombe had already mentioned the concerns that we have with nutritional assessments and the challenges we have with getting our patients to an appropriate whether it's the Dietitian, Nutritionist, or Diabetes educator. But I want to talk a little bit more about this paragraph, because it is a little bit ambiguous. And we'd like to see some more clarity in here.

Basically, what I'm looking at and I'm looking at it in terms of, I've been a registered dietitian for about 30 years and I'm also a certified wound care specialist. And so, when, when I look at this, I see a number of terms: basic assessments, standardized assessment, formal nutritional assessment, all very different and more related to a patient that might be hospitalized for and having a dietary council for multiple different reasons. I think we really need to look at an assessment that is appropriate to wound care.

Some of the, some of the expected parameters in here, may be out of our control and not directly related to the wound. And one of them that stands out is when you're looking at the BUN and creatinine, many of our patients are in renal failure and they're going to have elevated BUN and creatinine and that is going to be something that we will not be able to control and they're not necessarily reflective of the wound healing. Some of the parameters that we can look at are going to be our albumin pre-albumin, glucose A1C but we need to be really clear that they all have different half-life and we should look at how frequently we need to pull those numbers.

So, a general term that the recently documented, recently it might be different for each of these parameters. So again, want to look at some clarity in this paragraph and in regard to nutritional assessment and have some more appropriateness to wound care and nutrition.

Thank you for listening.

Dr. Larry Clark:
Thank you. In fact, you know, this is an opportunity. Let me, let me just say something here. You know, you've heard sort of a balance, or dynamic that, I think one of our speakers talked about, imaging, and the ability to appropriately do a vascular assessment within a couple of weeks of the initial patient encounter. And then, we've had commenters and people contributing to the policy, and making suggestions that, you know these, this imaging assessment should be conducted in the context of the first visit. Obviously, many facilities do not have that ability that you can have the patient come in for an initial assessment and get imaging that day. And, perhaps, in some areas, that is going to take significant time in transporting a senior to get that assessment. I think though [inaudible] we expect that some of these things are done. But this is sort of your opportunity and background: you know, like if you're talking about stuff like the Aspen criteria and nutritional assessment, you know, versus but the thing is, I think you would agree with the bedrock situation that a patient who is nutritionally impaired, is not going to heal well. And unfortunately, we have, in our jurisdictions, patients who don't even get assessed, and yet they're into, you know, significantly down the road in wound care. So, I would appreciate in your comments if you could specifically address how a patient, how you think a patient should be evaluated in a frontline clinical situation. Thank you. Ann, anything I missed.

Dr. Raeann Capehart:
No, I don’t have anything to add. Thank you.

Thank you, Ms. Madura, for your comments.

Our next commenter is Dr. James Alexander.

We were not able to identify whether or not Dr. Alexander is on the call. If you are and possibly using a different name, can you please send us a message using the chat box.

Dr. Larry Clark:
I got a message. I'll interrupt you here. Dr. Alexander is unfortunately in an unstable internet area, and so, sent me a communication that I just got. So, we will be if the next speaker is ready, we will be moving ahead. I just want to say, and thank, again, people like Dr. Alexander, Dr. Tettlebach, Ms. Couch, Ms. Woelfel people who contributed in terms of literature review, and the CAC that led up to this a number of months ago. I am pleased that he is a general surgeon and compliance officer for a consulting firm in Texas, and several hospital associations. I think he generally approved the policy, sending some specific comments in directly. But I do want to take one minute here, in the middle of the meeting using his time. I'm just going to remind or ask everybody, if you take a minute or two, or maybe a little more than that, but take a look at the implications of the 21st Century Cures in policy development, and look at the chapter 13 of the Program Integrity Manual. I think, in our current situation of trying to cover medically appropriate interventions for our senior and disabled populations, I think that there may be situations where petitioners find that coverage or technologies may be covered in the absence of policies, particularly, if FDA approved and having an established coding convention. So, with that thought in mind, I ask people who sometimes come in and say, well, you know, we'd like a policy or something. Sometimes, it may be more advantageous to allow the coverage process to pass through, in this environment. So, I ask you as part of the background to today's discussion if you would familiarize yourself with the 21st Century Cures process, and with that, thank you and Jocelyn, if we're ready, can we move on to the next speaker?

Jocelyn Fernandez:
Sure, our next commenter is Ms. Kara Couch.

I could not identify if she is on the call or not. Ms. Couch, if you are on the call, please send us a message using the chat box.

[silence] Oh, I got a message here saying that she will be calling soon.

So, why don't we move on to the next speaker, and we can come back to Ms. Couch when she does call in.

Our next commenter is Ms. Patricia Land. Ms. Land, are you on the call? Can you identify yourself by sending us a message using the chat box? Give us a minute or so.

[silence] Okay, I did not see a reply. Let's move on to the next commenter.

Ms. Karen Ravitz. Ms. Ravitz, your line is open.

Karen Ravitz:
Okay, I think you can hear me now. Good afternoon. And thank you, Dr. Clark, for the opportunity to provide feedback on this Wound Care LCD. My name is Karen Ravitz and I serve as a Senior Policy Advisor to the Coalition of Wound Care Manufacturers. The Coalition represents leading manufacturers of wound care products used by Medicare beneficiaries for the treatment of wounds, including those that are the subject of this public meeting. The Coalition has had a long history of working with the AB and DME MAC Medical Directors, as they have developed medical policies. While the coalition will be submitting formal written comments to the draft Wound Care LCD and policy article, I would like to highlight two issues today.

The first is regarding the definition that Noridian has used regarding advanced dressings under this section entitled, Dressing Changes for Wound Debridement. The draft policy states, “Advanced dressings, used with increasing frequency to provide gentle debridement in the treatment of acute wounds, chronic venous diabetic, and pressure ulcers.” We have concerns with this definition since the way it is written is incorrect, not all advanced dressings debride.

Advanced dressings are very diverse such as collagen, come excuse me, collagen, composite, contact layers, foam, hydrocolloid, hydro gels, allergen aids, fiber jelling products, specialty absorptive and transparent film.

Just as their technologies are different, so are their functions and or mechanisms of action which include but are not limited to absorb drainage, hydrates, dry tissue, provides moist environment, maintains moisture, or protects tissue, conforms to depths or contours, provides active bacterial control, provides control odor, enables autolytic debridement, helps with deposition and organization of new collagen fibers, and granulation tissue formation.

Advanced wound care treatments revolve around the principle of moisture therapy, which provides adequate moisture to the wound to encourage natural cell repair, while at the same time allowing the wound room to breathe. Film dressings are designed to adhere firmly to the skin surrounding a wound without sticking to the wound itself. This moist environment helps prevent necrosis, which is death of cell tissue, cells in tissue through disease or injury. Hydro gels are designed to keep dry wounds moist and they are especially useful for deeper wounds. Where hydrocolloid dressings contain hydrophilic substances such as cellulose in gelatin, which absorb dirt, fluids, bacteria, and form protective gel mass. In the past, MAC policies referred mostly to advance dressings autolytic properties in order to qualify for coverage under the surgical dressing benefit.

The expansion of the definition of debridement in 1994, beyond surgical debridement, to include autolytic was what allowed the surgical dressing policy to expand coverage to include advanced wound dressings and not just standard or traditional gauze dressings. Taking all this into consideration, we ask that Noridian consider the following definition for advanced dressings in place of what is currently in the draft LCD. And, that is advanced dressings once with composition and structure, designed to create an optimal wound environment, by helping to remove dead tissue, through autolysis, or other debridement mechanisms, creating and maintaining a moist wound environment, and providing a bacterial and or viral barrier to the outside environment.

The other issue I would like to discuss is largely an administrative issue. I have read lots of LCDs and policy articles over the years. It is not common for the Documentation and Utilization sections to be contained in both the LCD and policy article, as Noridian has done for this Wound Care LCD. However, if Noridian wishes to place these sections in both the policy article and the LCD, the language should be exactly the same which currently, it is not.

The policy article contains one additional requirement and the documentation section, which is not present in the LCD and specifically that language reads: “When the documentation or lack thereof does not meet the criterion for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary.” Again, this language was not included in the LCD. And I say that any language in one document should be mirrored in the other. In the event, that Noridian takes the unusual step to include the documentation and utilization in both.

There is also language in the policy article that acts like a utilization parameter which is not only inappropriate, that same language is not contained in the LCD. Specifically, in the section discussing surgical debridement, which as an aside has inaccurate and outdated language, the policy states the following: This A/B MAC allows payment for an aggregate total of one independent tissue debridement on a given day of service. Any number greater than the aggregate total of four or one both feet per date of service will result in a denial, which may be appealed with documentation, justifying the additional services. Once debridement is properly done repeat debridement is not expected for several days afterwards.

The CPT clearly identifies what, 11042 through 11047 are and how they are defined. But Noridian is trying to go a step further and in its own description it appears a limitation is being placed within the policy article, which is not appropriate. Utilization parameters go to the very heart of coverage and therefore this language should be placed, should not be placed in the policy article, especially when it’s not contained in the LCD itself.

I thank you again for the opportunity to provide these issues with the draft LCD, and as stated, the coalition will be submitting more in-depth formal written comments. Thank you.

Dr. Larry Clark:
Ms. Ravitz, you do actually have a couple of minutes? If you have it handy, you had mentioned some inaccurate and outdated language in addition to your other comments. Do you have that ready right now that you could just mention it?

Karen Ravitz:
I can, let me just flip to the page just very, very quickly, but I can. You talk about in there. And I think Marcia Nusgart has already addressed that, but you do talk about. partial and full thickness wounds. That term is not used any longer in that surgical debridement section. So, that's no longer utilized. So, that's one.

And then also within that same, within the surgical debridement section, there is also language that talks about excision to excise, which actually is inappropriate as well. It should be removed.

Dr. Larry Clark:
Okay.

Ms. Karen Ravitz, J.D. :
I'm trying to see if there's something else within this to provide to you. There are a couple of others in terms of inappropriate language as well, that is outdated, one has to do with actually it's in the LCD itself. It's not in the policy article. Did you want me to address that as well?

Dr. Larry Clark:
Go ahead and take a minute to do that.

Ms. Karen Ravitz, J.D:
Sure. I'm happy to do that. So, in the LCD itself, there is a discussion about skin replacements, which again has already been addressed, it should not be skin replacements. It should be cellular and or tissue-based products for skin wounds or CTP’s. And that is on page number four in the policy. There is also language, again, in this wound care surgical debridement section, that talks about surgical debridement occurs only if material has been excised, it should be removed, and not excised. Because that, again, is incorrect and outdated language.

There is also in the low frequency non-contact non thermal ultrasound section, there is reference to wounds and ulcers which are too painful for sharp or excisional debridement. That is no longer used, it is, should be selective or surgical debridement.

And then a little bit further down in the limitation section number three, there’s reference that a surgical excisional debridement was performed. And the word excisional is no longer used, it's just surgical debridement. I'm trying to see if I left anything out, from what I can see in my notes.

I think that's the highlights. I might, I might have left 1 or 2 out, which we’ll obviously include in our, in our comments, but those are the main ones.

Dr. Larry Clark:
Let me ask you, excised then, in other words, you chose removed. Is the implication there that it is not specifically a surgical debridement, it may be by another technology? Is that why excised is becoming less frequently used?

Karen Ravitz:
I think it's just in part because CPT has, you know, created definitions and it's what's in and what's in the language there. So, they have, they have removed it.

Dr. Larry Clark:
All right. Thanks very much.

Ms. Karen Ravitz, J.D:
Sure. Thank you.

Jocelyn Fernandez:
Thank you, Ms. Ravitz, for your comments.

Let us go back to commenter Number 11, Ms. Kara Couch. I do see that she has called in.

Ms. Couch, your line is open.

Ms. Kara Couch:
Thank you very much. I appreciate accommodating my schedule today. My name is Kara Couch, and I'm a family nurse practitioner and certified wound care specialist. I was asked by Noridian to participate on the CAC for this wound care LCD. Hello, Dr. Clark. Thank you for having us, having me back today. I appreciate it. I've been working in wound care and limb salvage for the past 18 years. My early background is in diabetic limb salvage while working at MedStar Georgetown University Hospital and I then worked at Walter Reed National Military Medical Center on our war wounded. Currently, I'm the Director of Wound Care Services at the George Washington University Hospital in DC.

I speak locally and nationally on wound care topics, and have co-authored, or authored numerous publications in peer reviewed journals. For the past few years, I've been focusing on wound care guidelines and policy and how it impacts our patients and outcomes and the current co-chair of the International consensus venous ulcer guideline for the Association of the Advancement of Wound Care.

I've been on the Guidelines Committee for the past 10 years. I am the current Secretary of the AAWC and I also serve on the Board of Directors of the Alliance of Wound Care Stakeholders.

I appreciate the opportunity to provide you my initial feedback of this draft Wound Care LCD. The comments I'm providing to you today are based on my personal clinical experiences, treating patients with wounds.

While in general, I feel that this LCD is quite good and contains new language regarding the recognition for the importance of biofilm and wound management, which I greatly appreciate. I still feel the LCD contains significantly problematic language. When I reviewed the LCD and the corresponding policy article, I identified a number of clinically inaccurate as well as inconsistent statements that will need to be remedied prior to this policy becoming final.

Some of the prior presenters have already addressed some of this, so in order to not duplicate, I'm going to focus my comments on four specific areas.

One, the definition of adjunctive therapies, two the omission of total contact casting and compression from the Wound Care LCD, three, who can assess or re-assess wounds and four language regarding vascular screening.

With respect to adjunctive therapies Noridian states, adjunctive measures include, but are not limited to appropriate control of complicating factors such as pressure, EG offloading, padding, or appropriate footwear, infection, vascular insufficiency, metabolic derangement, and or nutritional deficiency.

I would argue that any measure, which is considered standard of care, is not an adjunctive measure.

Adjunctive therapy refers to additional treatments used together with the primary treatment or the standard of care to achieve the desired clinical outcome.

Acceptable types of these adjunctive therapies, which are therapies with robust quality research to support their use in wound healing include Negative Pressure Wound Therapy and Low Frequency non-contact ultrasound. These are items which Noridian has already included in this policy

Offloading a patient with a diabetic foot ulcer is considered standard of care.

Compression of a patient with venous insufficiency and a venous ulceration is considered standard of care.

Neither of these in clinical practice are considered adjunctive therapy yet Noridian has identified them as such.

Further in the LCD Noridian states, quote, “Application of Paste Boot, Una Boot, may be of value, application of a multi-layer compression system may be a useful adjunct to wound care management, particularly with venous ulcerations of the lower extremity” end quote. Again, these treatments are considered standard of care and not an adjunct to treatment. There is robust evidence to support total contract cast, compression bandages, multi-layer compression systems, et cetera as the standard of care. They are all important standard treatments and should be recognized as such. It is not accurate to say that these are adjunctive therapy.

With respect to the omission of Total Contact Casting compression from the LCD, I know that Noridian would like to ensure that this wound care policy is complete, and therefore, TCC and compression need to be included. Noridian listed out so many types of treatments to include negative pressure wound care therapy, ultrasound, Una Boot, to name a few, but omitted TCC and compression from this LCD. It's important to recognize these treatment options again as they are standard of care.

Another important issue to me is the statement in the LCD, which reads, quote, “A wound that shows no improvement after 30 days may require a new approach, which may include physician re-assessment of underlying infection, offloading, biofilm, metabolic nutritional vascular problems, which may inhibit healing.”

A wound is not showing any improvement may need to be re-assessed. But there are other qualified providers that can and do re-assess non healing wounds, myself included. As I stated at the onset, I am a nurse practitioner. I can and do assess wounds and I'm not the only qualified provider type who can do so. Noridian needs to change this language so that all qualified providers and practitioners are able to re-assess a wound as currently done in clinical practice and in accordance with State and government licensure.

I also have an issue regarding the 30-day requirement as written, if a patient, and therefore the wound separates a setback such as a severe heart attack than the 30-day clock should reset.

Noridian has not made any provision for the 30-day clock to restart, should there be a setback or style in the healing. Resetting of the 30 days is very important, as different interventions will be taken to treat the patient, depending on their status. It would also be helpful to have Noridian clarify when the actual 30-day requirement would begin.

It is possible that Noridian could address all of these issues, if the language was modified to read, a wound that shows no improvement after 30 days requires a new approach, which may include re-assessment by a qualified provider of underlying infection, offloading, biofilm, metabolic, nutritional or vascular problems, inhibiting wound healing, or a new treatment approach. If a patient suffers in medical or surgical condition, that negatively impacts wound healing progression, whether it's simply a style or a setback in healing, then the 30-day requirement would reset.

My last point that I would like to address is related to the requirement of the vascular assessments. While I do not have an issue with requiring this assessment per se. I do have concerns about the language as written in the draft.

While I have several concerns, I will highlight two in my comments today.

First, the LCD states, arterial and venous circulation in the extremity be confirmed within two weeks of the initial patient encounter. I believe it is unreasonable to require this confirmation within two weeks. I am not sure why the confirmation is required for the two weeks and what evidence was used to establish this timeframe. It seems rather arbitrary.

I'm not disputing that confirmation is appropriate to document in the file, but simply the timeframe is not reasonable. I am in a level one trauma center in an urban location in Washington, DC with a vascular lab in my clinic and I can't and can ensure that my patients would get these assessments completed within the two-week timeframe. There are also many regions in the country where there's simply not adequate capacity to achieve this goal, particularly in rural areas. To be consistent with assessment's required in this policy I would recommend the language to read that arterial and venous circulation in the extremity be confirmed within a timely manner or in 30 days. The 30-day timeframe is consistent with what the draft LCD is proposing for nutrition assessment.

It's also not clear whether every patient will require that type of assessment, since Noridian does not clearly state that this requirement is only for patients who are suspected of having a venous ulcer. Clarification on this point needs to be addressed.

Furthermore, the draft LCD refers to the venous doppler and states, Venous doppler is of less certain value in the assessment of venous ulcers. Venous doppler is not considered standard of care. There is a more accurate test to use, then Venus Duplex. A venous duplex or ultrasound is generally considered the standard of care for a patient suspected of having a venous ulcer. This exam is more comprehensive, as such, the language and the policy needs to be revised in order to adequately describe the assessment that should be performed on the patient suspected of having a venous ulcer. I believe the language state on the venous side of the circulation, the duplex ultrasound is the primary diagnostic tool for initial investigation. Lower extremity Venus disease may be divided into obstructive/thrombotic disease, or venous reflux/incompetence. While ultrasound is typically the modality of choice for both pathologies, the test must be properly tailored.

A longer, more detailed recommendation would be provided in the written comments to Noridian. What is important is to request the language regarding screening, be modified to correctly and adequately describe the current practice.

In conclusion, I greatly appreciate the opportunity to present my comments, while I just skim the surface. I wanted to provide you with examples of why I believe this policy needs to be revised prior to its implementation. I look forward to continuing to work with Noridian and to be a resource as this policy is finalized. Thank you.

Jocelyn Fernandez:
Thank you, Ms. Couch, for your comments.

Dr. Larry Clark:
Thank you.

Jocelyn Fernandez:
At this time, let us move to commentor number 14.

Dr. Alejandro Perez. I don't see that he has called in but Dr. Perez, if you are on the call, can you please send us a message using the chat box, so we can identify you? Please give us a couple of seconds for a reply.

[silence] We have not received a reply. So, let us move on to the next commenter.

Mr. Dennis Reilly. Mister Reilly, your line is open.

Mr. Dennis Reilly:
I apologize, I'm not sure how I got placed as a commenter today but thanks for everybody’s comments and please carry on.

Jocelyn Fernandez:
Okay.

Dr. Larry Clark:
Thank you for attending.

Jocelyn Fernandez:
Our next commenter is Ms. Emily Greenstein.

I also could not identify, oh, alright.

Ms. Emily Greenstein:
I'm sorry, okay, thank you. Alright, so first of all, thanks for allowing me to speak today. My name is Emily Greenstein and I'm talking on behalf of wound care providers at Sanford Health.

I am a Certified Wound and Ostomy Nurse practitioner at Sanford here in Fargo, North Dakota. I've been in wound care for about 13 years, and I'm a member of many different clinical wound care organizations. I am currently the president-elect for the North Central Chapter of Wound Ostomy Incontinence Nurses. I'm also a clinical member on the Board for the Alliance of Wound Care Stakeholders, whom you heard present earlier.

I would like to say, thank you for all the work you did on this very important policy. I'm excited to see this come out not only as a policy but an educational tool because in 2018 and 2019 I was able to provide wound care education to your partners on the DME MAC side at Noridian.

So, after looking through the policy, there are a couple of things that we would like to mention. I will be, kind of, echoing some of the other comments that the other speakers made, however, I hope that I can add, or maybe give you a different perspective on some of them as well.

The first thing I want to talk about is the use and consistency in the language. Throughout this document, you use terms such as wound ulcer, skin ulcer and ulcerated skin interchangeably. These terms can have clinically different meanings. For example, an ulcer may be deeper than the skin level. You can have an ulcer wound that is through all the layers of skin, even affecting the muscles, tendons, and bone. Literature defines a wound as a break or damage in the skin as a result of an injury, and an ulcer, as a result of an underlying cause. Examples of this would be a venous stasis ulcer which is caused from venous reflux and insufficiency. According to the language in the ICD-10, a wound is something traumatic, and an ulcer refers to a break in the skin that fails to heal, as it should and is chronic in nature. Our ask is that you remove the terms, skin ulcer and ulcerated skin from the policy.

Also, that you consider changing the title of the policy to the Wound/Ulcer LCD.

The next topic that I would like to address which was previously addressed by many other presenters, is the terms acute and chronic. In the policy, you mentioned that acute wounds will not be covered. However, then Noridian states that this LCD will cover all wounds that have complicating, metabolic and physiological factors. As a wound care clinician, we often treat patients that fall under the acute wound classification, because they don't meet the 30 day mark that Medicare uses to classify a wound as chronic. However, they may have many underlying comorbidities which makes it extremely important for them to seek advanced wound care early.

For example, I have seen several patients with underlying autoimmune diseases. These patients are on auto immune suppressants, and it is very important if they get an ulcer or a cut that they seek care at a higher level right away because of their risk for developing an infection, complications and possible hospitalization. The problem with the statement of acute wounds not being covered, is it is contra indicating to the pathophysiology and clinical practice in a sense that sometimes chronic wounds need to be turned back into the physiological acute state. For example, if you're looking to classify a wound purely on the phases of healing, as an acute wound, typically acute wounds go along the healing cascade as a well-organized process, leading to predictable tissue repair. The injury occurs, coagulation, inflammation, proliferation, and then remodeling or scar formation. When a wound becomes chronic, they're often stuck in the prolonged or excessive inflammatory phase due to persistent infection the inability of dermal and epidermal cells to respond to reparative stimuli. And often, the patient has an underlying pathophysiology such as diabetes.

If you look at all the well accepted treatment models, which were actually mentioned earlier by some of the other presenters, the use of time which is a multi-step approached chronic wound care. The first recommendation is wound bed preparation. When you debride a wound that is chronic, you're ultimately trying to put that wound back into the acute inflammatory state. The idea of putting a wound that is chronic back into an acute state on a molecular and cellular level is that the wound will then continue to go through the healing phases to proliferation and remodulation. So, our ask, or question to Noridian is, “What are you exactly trying to get at when you're saying that acute wounds are not covered in this policy?” We are looking for some clarification on this terminology.

The next topic I would like to discuss is on this section of debridement. Noridian correctly states that wound care must be performed in accordance with accepted standards for medical and surgical treatment of wounds. The appropriate interval and frequency of debridement depends on the individual clinical characteristics of the patient and the extent of the wound. The extent and number of services provided should be medically necessary and reasonable based on documented medical evaluation of the patient's condition, diagnosis, and plan. For example, I may have a patient who requires serial departments because of the size of their wound, their tolerance, the type of tissue present in the wound or the number of wounds that they have. Noridian states. in this policy utilization parameters, only a minority of beneficiaries who undergo debridements for wound care appear to require more than 12 surgical debridement services in a three hundred and sixty day period and continues to say that it's unlikely that more than four debridements are needed in a month or 30 days. It is unclear from this paragraph whether Noridian expects that these limitations are per wound, per patient, per episode.

We recommend that this entire paragraph be stricken from the LCD, as we believe, that Noridian correctly already stated that the interval and frequency of the debridements depends on the individual characteristics of the patient. Should Noridian determined that this language needs to remain, then I think everyone on this call can agree, that Noridian ensures that the policy clearly states that these parameters are, in fact, per wound, per patient, per episode.

The reason behind this thinking is that oftentimes we see patients with multiple wounds that may need to be debrided at different visits, depending on several different factors, or you may have a patient who has a wound that is healed, but then presents with a new wound on a different location on their body that needs management and debridement all within that three hundred and sixty day timeframe.

The next topic I would like to discuss is the inclusion of palliative care. First of all, we'd like to commend Noridian for acknowledging and recognizing that not all wounds will heal, and that some need to be managed through palliative care. However, the policy states that wounds of some Medicare beneficiaries residing in skilled nursing facilities may not close, heal, or be amenable to self-care in spite of optimal therapy. The concerns we have with this section include the fact that patients may need palliative wound care throughout a number of settings, not just in skilled nursing facilities. Oftentimes, we see patients who are still at home that I know as a clinician will never heal. Since there are currently no specific guidelines to quantify when a wound is unhealable, the point at which a patient enters into palliative wound care, is a clinical decision based on the patient's underlying serious medical conditions, an acceptable risk benefit ratio for aggressive interventions aimed at healing, or be made after the failure of some reasonable period of aggressive wound care. It must also be recognized that a patient may be in palliative care due to a life limiting process, but not necessarily palliative wound care. An example of this, is a patient who is terminally ill due to cancer who develops a pressure ulcer that requires topical wound care.

On the flip side, however, the fact that a patient is in palliative wound care does not mean that they're at end of life or terminally ill. An example of this, is a patient that I have seen personally in the past who has a complex ulcer on his leg due to mixed venous and arterial disease. He has an arterial disease and cannot further be treated and according to the Noridian policy on Venous Ablations, he does not qualify for treatment of the veins, due to his underlying arterial disease, He's not a surgical candidate and would not survive open or bypass procedure. So, goals of his care include pain management, local control of bio burden, and exudate and infection prevention, which are all mentioned as palliative care in the policy.

It’s important to recognize that a patient status may change throughout their course of treatment, thus allowing wounds, which were previously considered unhealable to reenter active therapy. For example, the patient I had just mentioned, if he was agreeable and able to pay for his venous ablation treatment out of pocket, then he would be considered back into active treatment.

In addition to improving the quality of life, one other potential beneficial outcome might be, that with appropriate palliative care wound care, their need for hospitalizations, IV therapies, and other expensive interventions would be reduced. Dressings and other interventions focused on reduction of infection may be necessary for these types of patients. However, dressing regimes may need to be simplified for its limitations of the caregiver. All of these things must be considered.

Debridement may still be required to achieve the goals of palliative wound care as well. Reducing the burden of devitalized tissue can improve odor and prevent bacteria from growing. In fact, non-healing wounds may continue to undergo necrosis and thus require periodic debridement to maintain a clean environment. As many people had already talked about when they talked about their debridement, we know that wounds that contain a lot of debris and dead tissue can become a breeding ground for bacteria.

Under the documentation portion related to palliative care, we agree that the documentation should support the medical necessity and should be in the patient's medical record. However, in other areas of the policy, you state that a wound needs to show progression and healing. Our question is, how will a patient who is never going to heal be covered? It is unclear from this policy, whether palliative care will actually be covered or not.

I do know that the alliance does have a draft policy for palliative wound care, that they will be attaching with their comments. This document will go into greater detail about palliative wound care and the importance of it. So, this concludes our statements. We will be presenting our written comment as well, and, once again, thank you for giving me the opportunity to express concerns related to this very important policy.

Dr. Larry Clark:
Thank you, and would you please, I understand you're going to be sending something on a palliative wound care and your point is understood on the per patient per wound concept. But would you also note the paragraph this specific paragraph that you recommend striking as the alternative?

Ms. Emily Greenstein:
Yes.

Dr. Larry Clark:
Dr. Capehart, any questions or thoughts? If not, do we have we're running a little bit ahead of schedule, Jocelyn. Do we have our other folks lined up or anybody that we skipped over available to come on?

Jocelyn Fernandez:
Our next commenters are Dr. Larry Santi and Dr. Jeff Lehrman

Dr. Larry Clark:
From the APMA, and they are concluding. So, let's go with them and then give a few more minutes, or I think Ms. Land is still outstanding. So, let's proceed with Dr. Santi and Lehrman.

Dr. Jeff Lehrman:
Thank you, Dr. Clark. Good afternoon, everybody. Dr. Jeff Lehrman and I'm here with Dr. Larry Santi. I am a podiatrist and a certified professional coder. Many years of wound care experience, and I served as the Medical Director at my hospital’s outpatient department Wound Healing Center for many years. Dr. Santi also has provided wound care for decades. Dr. Santi trains surgical residents as a podiatrist, and he is on the Board of Trustees of the American Podiatric Medical Association. I am a consultant to APMA's Health Policy and Practice Department, and I'm also on the board of directors of the American Professional Wound Care Association. Today, Dr. Santi and I speak on behalf of the APMA members. We have four items. We would like to please discuss. We will be submitting formal comment. We've already started drafting that letter but appreciate this opportunity to editorialize to a degree and explain what we will be submitting in writing.

Like I said, four items.

The first one is number 24, under Limitations in the draft, LCD speaks to the Comprehensive Plan of Care in all caps, Comprehensive Plan of Care. We agree that that is good policy, and a good thing to have, and when drafting guidance based on peer reviewed literature, that's great. We should have that. Our concern is that we have attempted to identify exactly what a Comprehensive Plan of Care is, and what elements should be included. And we have found varying answers to that, so we do not contest the requirement, we think it's fair and appropriate.

What we ask is that you please list what the elements of that Comprehensive Plan of Care should be. We just want to follow the rules. We want to know what the rules are, we don't want to guess as to what you're looking for, when it comes to a Comprehensive Plan of Care. So, if you could just bullet, list the items of what should be included, that would be appreciated, and will help us and our members to comply.

The second item speaks to a sentence in the draft LCA. This sentence I'm referring to singles out podiatrists. I'll read the one sentence from the LCA. It says, “Consultation services rendered by a podiatrist in a skilled nursing facility are covered if the services are reasonable and necessary and do not come within any of the specific statutory exclusions.” Podiatrists are physicians, as defined by the Social Security Act that created Medicare. No one physician type should ever be singled out from other physician types. Under Medicare, MD, DO, DPM must be treated equally without one singled out or spoken to differently than the others, as long as we are all practicing within our scope, we're concerned that podiatrists have been pulled out and identified here differently, than other physician types, for some reason. The sentence is actually fine, the guidance is correct. The problem is that, for some reason, podiatrists have been singled out. So, we respectfully ask in keeping with the guidance of the Social Security Act that that word podiatrists be changed to physician. If you just change that word, podiatrists to physician, that will end our concern that exists here and shouldn't be a problem because that guidance does apply to all physician types. So, again, if you could please change that word from podiatrists to physician, that would address our concern.

The third item we want to speak to that again, we will have in our written comments, but just wanted to explain it a bit here is number 22, under the limitations in the draft LCD number 22 speaks to the assessment of vascular competence. And that's great, right. We're supposed to be drafting these things based on peer reviewed literature, and it's important that assessment of vascular competence be performed. So, we applaud Noridian for including this and making sure that beneficiaries are receiving appropriate vascular competence. Our concern is that the means by which we accomplish assessment of vascular competence are listed, and there are a bunch of device-based methodologies there, like ABI in arterial doppler, what's missing is physical exam like palpation of pedal pulses. And that's not listed there as one of the means by which we can accomplish assessment of vascular competence. And for some patients, that's not appropriate, for some patient’s, palpation of pedal pulses, when it comes to the lower extremity alone is not good enough. For example, we have an abundance of peer reviewed literature that suggests that for diabetic foot ulcers, palpation of pedal pulses isn't good enough even if they're palpable. However, there are other patients who will be treated under this policy for which physical exam and just palpating pulses is fine, and these other things may not be needed, and, and where this comes into concern is later on, in that same number, 22, where it states, it is the expectation that arterial venous circulation be confirmed within two weeks. And when the introduction to this number 22 lists, the means by which we accomplish that vascular assessment, but doesn't include physical exam, we're concerned that if we do confirm adequate circulation via a good thorough history and a good physical exam, without the need for those extra services, that might not be considered to be having performed that vascular assessment within two weeks. So, and that might lead to us ordering extra studies just to check a box, which that concept has been spoken to already today, where we might be sending a patient to have another study with which incurs costs to Noridian, and tremendous burden. Some of these patients have such a hard time getting around and transportation, and it is such a hassle for them to get to a vascular center. And my goodness, none of us would want our Medicare beneficiaries running around trying to get these studies done if it weren't medically necessary. But rather, they were having it done just so that we could check a box on a payer policy. So, we see two ways, this concern could be addressed, if you just include physical exam, when appropriate, if you include physical exam, when appropriate, in that list of means by which we can accomplish a vascular exam in the first part of that number 22, that would end this concern. I suppose, another way, I don't think it's as good of a way, but we, we wanted to list options, rather than just tell you what our issues were. We wanted to provide solutions to these issues.

The second way that might be addressed is if you prefaced the two week requirement with, for patients who are not following the expected progression of wound healing, and we used your language from the nutrition section for patients who are not following the expected progression of wound healing. I realize I'm dictating request here, and that's why we'll, we'll, of course, submit this in written form. But just want to share, we're providing not only our concerns, but also our suggested fixes.

And our fourth item is a really easy one. The document lists the deadline for comment as March 15, yet your website, and you, yourself, and the introduction to today's events. Today's event listed that deadline is March 13th. So just consistency with the March 13 versus March 15 date, so that nobody messes up with that. And I've left enough time for you to respond or ask us any questions if you wish.

[silence]

Dr. Larry Clark:
Thank you. I appreciate, you're in Fort Collins, right?

Dr. Jeff Lehrman:
That's right.

Dr. Larry Clark:
Okay, now, I appreciate the humor, and the shared. First of all, I got to, I got to apologize for the legacy language and the fact that you guys came on and joined us with not too much notice. But I think it's appropriate in that we did retire an older, existing policy and rolled some of that language in and I know that it particularly impacts your specialty ulcers and symptomatic hyperkeratosis. I think, was a policy where our regional podiatric associations and the National Association contributed a long time ago. So, the sensitivity about that statement is noted regarding. The problem that we're having in this. Since we're waiting, hopefully we're also going to see if we can locate Ms. Land and Dr. Perez, and if not, we'll conclude the meeting. We certainly have received a lot of good comments. Well, what I share the fact that physical examination and physical competency are not stressed enough. I mean, there's no disagreement there. The problem that we're having in our jurisdictions, which led to the development of this policy, and an attempt to build on what had been started by, I think someone mentioned that, sort of the template, the road laid out with the Novitas, First Coast policy. What we wanted to do was address the fact that we have, unfortunately, seen a lot of patients who are not really optimally, medically managed. And who, perhaps, like we find that several months into courses of failed treatment, the assessment of vascular integrity is, it's an afterthought. And so, one of the goals that we laid out was trying to make that, you know, one of the foremost considerations. And, as I said, we've had a whole range of recommendations that begin with, Oh, you know, our center can assess that patient. We believe that patients should be assessed with its first week. The vascular study should be ordered on the first day. And then we have the reality that I think it was Ms. Couch from George Washington talking about a level one trauma center where in the busyness of technology and the limitations and the authorizations in the real-world of medicine, you can't even get a patient done, you, know, in a couple of weeks. So, we're trying to balance that. The problem, unfortunately, on physical examination is the inability, you know, many times, I could say dorsalis pedis present etcetera. And, you know, maybe I was feeling my own heartbeat. I don't know the problem.

I totally agree with physical assessment, but if you are going to be doing a surgery and in a patient, you know, almost always with medical comorbidities, additional documentation of the vascular compromise is something that we, we can go back to that everybody can go back to at one point in space and time that this patient had this degree of occlusion that this patient had this.

This clinical situation that needs to be addressed before going down the road, that we see them going down, and then three months later, it's like, whoa, you know, this patient is never going to heal, because they don't have adequate perfusion. So, so, that's the balance that we're trying to strike, you know, from your organizational perspective, if you could address those issues, it would really be appreciated. And the other thing is, obviously, it slowed down the development of this policy. By having to, we did not want to create conflict for your practitioners in anybody else. And so, we decided we would roll up and retire that other policy, rather than having coding conflicts. So, I would ask if you could particularly comment on the, the old symptomatic hyperkeratosis policy and see whether or not we get a good job from your societal perspective. So that's really all I have to say.

Any other points from you or Dr. Santi?

[silence]

Jocelyn Fernandez:
Thank you, Doctors, for your comments.

Dr. Larry Santi:
Yeah, I know I think Dr. Lehrman summed up very, very nicely and APMA will send out comments [inaudible], not a problem. Thank you, doctor.

At this time, let’s move…

Dr. Larry Clark:
Let me ask Jocelyn, or anybody else?

Jocelyn Fernandez:
Dr. Clark, I will move back to commenter number 14, Dr. Alejandro Perez. I believe he has signed into the call.

Dr. Larry Clark:
Great.

Jocelyn Fernandez:
Dr. Alejandro Perez, your line is open.

Dr. Alejandro Perez:
Okay, hi everyone, so I'm Alejandro Perez I'm a vascular medicine specialist in Portland, Oregon. I'm also I'm the Medical Director for our Advanced Wound Center at Providence Portland Medical Center, and I'm also a board member of the Columbia Wound Care Community, which is a non-profit to educate on wound care in the Pacific northwest.

The reason I wanted to comment was to give some, a little bit more granularity to the current recommendations, specifically looking at 22, which was I think, referenced as far as the guidance, where venous assessment the proposal was to venous doppler.

The reason I thought it was worth commenting is when we are doing venous assessments for venous ulcers. What we are not necessarily looking for is whether somebody has an active clot or whether they have had a past venous thrombosis. We are, what we are actually investigating is whether they have venous valvular incompetence, because potentially if they have superficial venous valvular and incompetence, there may be potentially a remedy with a venous intervention that could help with wound healing, as well as prevent recurrence. So, I would ask that the language be amended, or clarify that for venous assessment, the test be not just venous doppler, which would be what would you order to rule out venous thrombosis, but in fact, venous valvular and competence evaluation, which includes a Doppler. So that would be to, to actually guide the wound healing as opposed to just rule in or rule out past or active of venous thrombosis. So that's point one, in regards to vascular assessment.

The second concern is, I think I, I do share a little bit of the earlier speakers’, concern about the time period, two weeks, I think, is reasonable in a large metropolitan area. Two weeks may not be possible if somebody lives in a more rural environment, or their local hospital was a Critical Access Hospital. Venus valvular incompetence testing often is not able to be adequately performed at smaller centers or smaller hospitals. And so, that two week, criteria may not be able to be met, by patients who live in more outlying areas, and that may not be a fault of their own, it may just be a circumstance of where they live. And so being in [inaudible]and that area, those centers may be inadvertently penalized simply for being in a rural area versus an urban area, or potentially patients who have limited insurance, and so maybe the wound center could do an ABI in the Wound Center, but if it's an outside test, that maybe, that co-pay comes out of their pocket, that they don't have. And so there may be some inadvertent penalties as well, for those who are in a more financially constrained social situation. And so, may, not so much requests.

But the, for consideration for the, for the writing of this guidance, is, although the two week asking of vascular assessment is, I think, appropriate, there may potentially be some language that could allow for, you know, if feasible or if allowable based upon patient's geography or financial circumstance. Because otherwise, where we potentially are asking people to do something that are not within their means, either physically because of where they live, or because of financial or geographic constraints.

So that's, that's a second component here of my points, and then my third point is just to speak to what some of the other earlier comments. Patients are different and they do have different reasons for coming in. Even though venous ulcer is probably by ICD 10 criteria or leg swelling related ulcers are probably the primary wound seen at a typical wound clinic. Even that arterial assessment probably is still feasible, but, you know, if somebody has, just as a very granular example, you know, a 30 year old person, no smoking history, no diabetes, but has a history of prior blood clots, and they come in with an ankle ulcer or particular ulcer, most likely that's what it is.

And so, even though we can say that they should have an arterial assessment, this may be a circumstance where we're ordering tests, even though we don't think that that is the clinical scenario. So, if somebody ordered an arterial perfusion evaluation of some sort, even though they don't think that that person meets that risk factor and clinically doesn't demonstrate that on exam.

There may be some circumstances where we're ordering tests that are not necessarily clinically indicated, but just to follow an algorithm. So, my, my ask for clarification is that even though arterial assessment within two weeks is appropriate, that there may be potentially some leeway to extend that out to four weeks, if, perfusion is felt to be adequate and patient making appropriate progress in regards to wound healing.

Again, this is specifically the situation that may be encountered with venous ulcers where the arterial perfusion really is not the issue and if the clinical history really does guide you in another direction to order arterial perfusion and everything is healing and progressing, is just an expense without added clinical benefit? But certainly, even if you think it's a duck and its quacking like a duck, and it's not healing like a duck should, I think arterial perfusion of course, should be pursued. But this is a situation where we have to allow our physicians or clinicians to actually use their brain to make a clinical on-site decision as to what they think is right for the patient.

And, and so my only fear is, we're creating potentially some expense, even though we're trying to protect the patient from providers who've maybe do not think of these things, that then they're potentially going to be leading in the other direction of creating more expense. That is because the patient, that the provider doesn't want to be penalized for being characterized as providing inadequate care. So, those are my thoughts, and those are my comments, and thank you for your attention.

Jocelyn Fernandez:
Thank you, Dr-

Dr. Larry Clark:
Again. Yes, I just want to say thank you, and thank you for your prior efforts on behalf of this policy. Dr. Perez was one of the other folks that contributed literature and helped guide our thinking as we started down this pathway. I would really appreciate, it can just be in an e-mail, but you know, the written comments about, you know, how you would revise the language on, you know, guiding venous thrombosis and venous assessment, your first point if you could maybe suggest some blank.

Dr. Alejandro Perez:
Certainly, I can do that.

Dr. Larry Clark:
The other thing, I challenge you again, as we did the last time we spoke, you know, months ago when we started talking about this process. What I would like is, again, the balance because I agree, the wisest thing is always prudent clinical judgement and the ability of a clinician. In other words, if your experiences that you're dealing with a venous ulcer, you know why we are mandating you to do additional imaging that's not necessary. On the other hand, you know, again, I go back to the problem we first discussed, which is, unfortunately, patients and particularly those with arterial insufficiency, that wind up in the wound care process.

And clearly with poor result if you're significant effort on their part and significant, if you want to say it medical morbidity, you know how we can balance that. We thought about the relatively innocuous and relatively low-cost requirement of the arterial doppler as balanced to the patient whose time, personal pain, risk and expense is significant if they are three months into an injudicious course of treatment and how we can balance that. So, I ask you for, for your thoughts on that, but specifically for the rewrite, but thank you for all your help on this.

Dr. Alexander Perez:
Certainly.

Dr. Larry Clark:
Jocelyn and Rachel have let me know that Dr. Perez will be our concluding speaker. Before Jocelyn gives out the information on where all of the written comments go and straightens out the date. She's going to give the closing and next steps.

I just want to say, the larger next step is going to be, and I'm going to make sure that I'm using that absolutely correct language and say that in terms of cellular and tissue based products, we deferred that part of this policy because, as I said, we did have to retire another policy, roll it in, make sure that it was reasonable in terms of the impact and professional associations.

Over the next few months, we will be getting, I think, the more difficult part two of this patient treatment effort in terms of dealing with those products and the next steps in wound care. So anyway, a lot of the people that helped out on this first part are willing to come back and help out again, and we really appreciate that. And thank you all for your attention today. We still have over 100 people in attendance with us. So thank you. Thanks to all of our contributors, Jocelyn, would you please conclude the meeting with the next steps?

Jocelyn Fernandez:
Dr. Clark, before we conclude, let us try one more time to see if Ms. Patricia Land, is on the call.

Ms. Land, if you are on the call, can you please send us a message using the chat box so we can identify you? Please give us a moment, to see if we get a reply back or not.

[silence]

Looks like we did not get a reply back.

So, this concludes our meeting for today. In closing, we would like to communicate the next steps in the policy development process. As a reminder, the comment period for the Proposed LCD will remain open until March 15, 2021, and not March 13, as previously reported. As noted earlier, all comments submitted in writing will be considered by our Medical Directors for the proposed LCD. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com.

Upon review of the comments received, our Medical Directors will either finalized or retire the proposed LCD. Please monitor our website or register for listserv notifications to be informed of actions taken to implement or retire our proposed LCD.

Dr. Clark, do you have any final comments you would like to make?

Dr. Larry Clark:
No, just thanks to you guys, Dr. Capehart and everybody who was here today.

Jocelyn Fernandez:
Okay, this concludes our meeting for today. Thank you all for attending. As we know your time is valuable. Enjoy the rest of your day.