Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Open Public Meeting - May 16, 2024 - JE Part B

Jocelyn Fernandez:
Good afternoon, everyone. My name is Jocelyn Fernandez, and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions.

Before we begin the meeting, I would like to make the following announcements. This meeting will be recorded. The recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting. Only those who registered to present will be allowed to comment on the proposed LCD.

For the presenters, you are being allotted four minutes to make comments. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one minute remains. At the end of your time limit, your line will be muted, and we will move to the next speaker in order to allow all remaining commenters time for their presentations.

We have added a closed caption feature in real time for today's call. Please speak clearly to ensure that the system will be able to translate into captions for display.

As I have mentioned, the recording and transcript will be posted to our website. 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.

In addition to comments that are made today, all comments should also be submitted in writing. All written comments received will be recorded in the Response to Comments Article.

I will now turn this meeting over to Dr. Raeann Capehart. Dr. Capehart, you may begin.

Dr. Raeann Capehart:
Yes, good afternoon, everyone. This is a collaborative presentation, and you will notice that most of the MACs are hosting a CAC on the same day, or certainly within the week, of this one. So we have asked that anyone finding it difficult to present their comments at this particular meeting should check with the other MACs. Now, I believe that the registration period has ended, so it will be unlikely that you can get onto their speaking schedule, should they have time.

Can we have the next slide, please?

Today's presentation is regarding a proposed Local Coverage Determination for the use of skin substitute grafts, or as they are frequently called, cellular tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers. These are for Jurisdiction E and Jurisdiction F.

The objective of this open meeting is to provide a platform for stakeholders and interested parties to comment on the proposed LCD. The presentations to follow are summaries of the comments submitted to date, but due to the time constraints may not be inclusive of all concerns. Presenters have been asked to submit written comments with supporting published peer-reviewed literature by 6/8/24, which will be addressed in the Response to Comment Article. Presenters today have only four minutes to summarize their positions on this LCD and unfortunately will have to be muted after that period to allow progression of the meeting presentations. Please be mindful of the timing alerts to allow your closing comments prior to our moving to the next presentation.

As a little background, a proposed policy on the use of skin subs and CTPs was presented in the fall of 2023 by another MAC in hopes of replacing their previous policies. Once published for notice, numerous concerns were expressed by the stakeholder community. Multiple stakeholder meetings and public listening sessions were again hosted to gain insight and understanding of these concerns. That particular policy was withdrawn, and logical outgrowth from the stakeholder input has contributed greatly to the proposed LCD we are discussing today.

There are several key points that we would like for all presenters and listeners to acknowledge. The FDA designation or CMS granting of a HCPCS code is not sufficient to meet the criteria for reasonable and necessary. The proposed policy is based on evidence and does not utilize FDA regulatory pathways for coverage determinations.

While the policy does limit frequency applications to four applications and 12 weeks duration per episode of wound care, there is a clear pathway allowed for additional applications or time, when medically indicated, to ensure beneficiaries have access to care for complex and difficult wounds, as suggested by stakeholders in prior listening sessions.

The policy limits treatment of diabetic foot ulcers and venous leg ulcers. Any use outside of these indications is at the individual MAC discretion based on evidence reviewed. Policy intentionally does not limit consideration for coverage to specific study designs, but focuses on sound methodology which allows investigators multiple options for future investigations while ensuring quality evidence is considered.

This LCD addresses the use of skin substitute grafts or cellular tissue-based products. And again, in the past these have been referred to as human cellular and tissue-based products, and now we're finding there's significant number that are not human tissue-based. These are for diabetic foot and venous leg ulcers. Chronic and acute wounds of other etiologies are not addressed in this LCD due to the lack of evidence supporting the use of CTPs over the standard of care. FDA classification indications are not the determinants of designation as a skin substitute or CTP, nor do they provide the reasonable and necessary threshold for coverage.

This LCD endeavors to define the standard of care which has been missing in so many policies of the past, the failure of which would justify the utilization of an advanced wound treatment, such as that of a skin substitute graft, HBO, and other advanced treatments for which documentation of failure of standard of care must be present.

For coverage under the Medicare program, an item or service must be reasonable and necessary. With any question, please see this particular CMS IOM Publication in the Medicare Program Integrity Manual, and this is available on our website should you not have the opportunity to scroll this down. Again, this full set of slides will be available.

Next slide please. Now we'd like to address, we'd like to unmute Ms. Leah Amir for her comments.

Leah Amir:
Great, thank you very much, and I will rapidly go through this. I welcome this opportunity to provide feedback. This is coming from speaking with many physicians.

First question we have with regard to the four weeks of standard of care followed by 12 weeks where they would be monitoring the use of four grafts. We want to know what exact time does the 12-week period start? If any of these patients were treated with some of the currently are the to be proposed non-covered skin grafts. Will there be a phase in period for that?

The next has to do with the specific notification that placement of skin substitute grafts CTP on infected ischemic or necrotic wound bed is not covered. There was a notification of diagnosing the wound bed.

There is an FDA approved product that identifies fluorescence imaging of bacteria location and load that has been demonstrated in multiple peer reviewed studies and randomized controlled studies that identifying the location of the bacteria and removing it enhances the survival of skin grafts and CTPs. And we propose this in both standard of care, and then once there's a plan to place skin grafts, then we welcome an opportunity to collaborate on how that might be part of this path to success for these patients.

Regarding the four skin grafts over a 12-week period, and that it would be based on documentation if indeed there would be additional reasons for that, will this be similar to a peer-to-peer conversation? Will this require a prior auth? We're interested in what that pathway might look like.

And with regard to some of the products, where about 211 of current products that are currently being used by considering them to no longer be covered. That's going to create an access issue for patients that do need some of these. And our question is, first of all, if those that were carrier-priced, will they continue to be carrier-priced based on claim-based information and medical necessity? And relative to further clinical trials that might be ongoing or planned for some of those products, would the clinical trial include both DFU and VLU patients or has been the standard, should the clinical trial be just DFU and then a separate study for VLU?

And we also look forward to discussion of what the control populations might look like. We believe it might be comparing the skin replacements with standard of care. We believe that might be the best, but if CMS has other options or considerations, we welcome that information.

And that concludes my presentation. We welcome and look forward to collaborating on ways that we can make this implementation feasible.

Dr. Raeann Capehart:
Thank you for your presentation.

Again, questions addressed in the comments, and certainly in the written submissions to us, will be responded in the response to comments.

And now let us move on to Mr. Hulse and Ms. Feight. I'm not sure which one of you will be speaking, but your microphones are unmuted.

Jennie Feight:
Hi, it's Jennie Feight. Can you hear me?

Dr. Raeann Capehart:
Yes.

Jennie Feight:
Okay. If you could move to the next slide.

We thank Noridian so much for the opportunity to comment. I am approaching this not as a clinician, but with my background in health policy and reimbursement and as a certified coder, auditor, and certified coding instructor.

Next slide.

MIMEDX really does thanks the MACs for examining all the products consistently and addressing many stakeholder concerns from last year. It appears that the intent is to provide equal evidence thresholds for product coverage, and we are glad to see that there's a pathway for treatment of patients that may require more than four applications. However, significant concerns remain, and we believe addressing these can make the LCD stronger and better for patient access. I will not focus on all of these because of the interest of time, but I will focus on the KX modifier and the ICD-10 diagnoses and will provide the rest in written comments.

Next slide. Next slide. Next slide. Sorry. Okay.

So, we have overall support for the KX modifier, but reserve that support for its use as an informational modifier to allow post-payment documentation spot checks or to monitor utilization trends. And our hope is that, you know, that those utilization trends might find, you know, a really good metric for where to set the next benchmark in terms of reasonable applications. We absolutely, emphatically stress that the KX modifier will not work if it is used as a surrogate prior authorization process, generates a lot of ADRs for the majority or all claims, or functions as a post-service but pre-payment review.

And we would just emphasize that in the listening sessions in 2023 for the withdrawn LCDs, stakeholders identified that a de facto appeal process will be catastrophic to patient care. There simply is not the volume of staff to handle a review for the exceptional cases, especially with the bar set at four. And then we remind that on a practical level, skin substitutes are buy and bill. Practices cannot routinely absorb the costs represented by purchasing these products and going through a lengthy appeal or review process.

Next slide. One more slide.

Finally, we noticed some, hopefully, oversights within the diagnosis list. The listed diabetes codes only contain those with the -621 suffix. So as written, it signals the intent to cover only diabetic foot ulcers and not lower extremity diabetic ulcers.

Jocelyn Fernandez:
One minute remaining.

Jennie Feight:
And we would just, yeah. We would just remind Noridian that ankle ulcers map to the -622 suffix, and so, as written, there's no coverage with the diagnosis list for anything as high as the ankle.

We also note that the diagnosis list covers only the most shallow ulcers, and that the recent big data studies really do support and provide corroborating evidence that deeper ulcers benefit. These were not excluded from those papers.

And with that, I'll conclude my comments and we thank you.

Dr. Raeann Capehart:
Thank you so much. And again, we will respond to those comments. I think there's some rationality to the basis of considering these diabetic foot ulcers that we realize codes are the same.

Our next presentation, Gunnar Johannson.

Dr. Gunnar Johannson:
Thank you very much. My name is Gunnar Johannson, Medical Director at Kerecis, and we just want to start repeating the thanks to the MACs for putting the focus on evidence-based methods and putting clear criteria for the evidence reviews. And we also want to say that we're not going to go over much of the usage criteria, but we are members of the Alliance of Wound Care stakeholders, and we support their comments on the application criteria. Yeah, the speaker is a salaried employee of Kerecis.

Next slide, please.

Just to update on the Kerecis products for skin substitutes from fish skin; let's skip that.

We want to focus on the evidence review process. We have heard that the evidence review process happened over a period of two years, but not with a clear cutoff period. The evidence that was reviewed in the LCD, evidence reviewed was data from '21 or 2019. But there was a significant study published in 2023, a diabetic foot ulcers study on 102 patients that seems to fill all the search criteria for being included in the review, and the full study publication with full outcome data is included and published.

So, our main comment is to have more insights on the evidence review process, and second the MIMEDX comments on having pathways for adding literature and for requesting coverage of new products.

And next slide, please.

To highlight some of the overview of the Lantis 2023 study that was not included in the review, this is a peer-reviewed publication with a PubMed ID. It's a randomized controlled trial comparing fish skin grafts to standard of care in diabetic foot ulcer patients. It has a large sample size and a multi-center design. It has well-defined and clinically relevant inclusion/exclusion criteria, appropriate standard of care comparator, rigorous statistical analysis with both intention to treat and per-protocol populations, robust randomized controlled design, independent blinded adjudication of healing outcomes, 12-week outcomes, and what was commented on a lot in the evidence review, that there's a lack of long-term follow-up. This actually included 12-month follow-up data for the patients. So, we see this being a study that has both clinically meaningful and statistically significant improvements in healing outcomes -

Jocelyn Fernandez:
One minute remaining.

Dr. Gunnar Johannson:
- and with a priority being on the beneficiary, we hope that this study will be considered.

Next slide, next slide.

And just to review, like the criteria that were listed by the MACs were decently broad, but we just want to highlight that many of the studies that were included both include fewer patients or were deemed by the MACs to have a higher risk of bias. So, we think these are all good studies that were included and just wanted to highlight that the Kerecis study well exceeds the requirements that these studies have passed.

Next slide.

Jocelyn Fernandez:
Thank you for your comments, but your time is up, and your line has been muted.

We will move to the next speaker.

Dr. Raeann Capehart:
Okay, our next speaker is Tasha Mears.

Let me just say to the former that please be sure that your studies are submitted, because they are certainly valid. And we will certainly review them, as has been stated in the previous thing.

I'm sorry, Ms. Mears. I have just interfered with about 30 seconds of your time.

Tasha Mears:
Next slide.

Thank you for the opportunity to comment on the proposed LCD.

Next slide.

Very briefly, I am an RN and Chief Operating Officer of a large wound medicine practice. Out of 30 years of healthcare experience, one-third of that is in wound medicine.

Next slide, please. Next slide, please.

I will cover three areas today, but two of them are the most critical if this LCD is enacted in its current state. The first is to cover at least seven skin substitute applications. The studies the LCD refers to occurred in HOPD settings on small wounds. I will preview some of our study data that was gathered in our private clinics that show that the LCD four application limit is inadequate. The second is to remove uncontrolled diabetes from the exclusion criteria.

Next slide, please.

Very briefly, the data I will be previewing today comes from our widespread, real-world wound medicine practice and is not vendor-sponsored.

Next slide, please.

You will see on this slide that we've compiled our data for our wounds that receive skin substitutes and performed an IRB-approved six-year retrospective study that is scheduled for publication in the Wounds Journal in September of this year. Again, this is not a vendor-sponsored study. And this slide illustrates the amplified healthcare disparities that will result from this ruling for our African American population, whose wounds are consistently larger and require more applications to heal than their Caucasian counterparts.

Next slide, please.

To demonstrate more study findings, this slide shows the progressive percentage of wound closure based on the number of applications. It is clear that there is significant progression of wound closure beyond four applications. Not displayed here, our data found that overall, for 122 healed wounds that received skin substitutes, including both DFUs and VLUs, only 44 of them demonstrated a healed rate after the fourth graft. That was only 36% of the healed wounds.

To summarize this data point, if the skin sub treatment option were to stop on the fourth application, that would leave 63.9% of the healed wound patients in our study unhealed. And that's a really high percentage and is in direct conflict with the LCD statement that it would be an exceptional case for a wound to require more than four applications for adequate wound healing.

So, our question is, are the MACs prepared for the onslaught -

Jocelyn Fernandez:
One minute remaining.

Tasha Mears:
- of post-care appeals that prove reasonable and necessary? Post-care appeal process is not a clear pathway and is a huge burden.

Next slide, please.

Fifty percent of the patients that healed in our study had a hemoglobin A1C of less than 7, while 50 percent also had a hemoglobin A1C above 7. So, we find this exclusion criteria unfounded and unnecessary.

Next slide, please.

Finally, our Chief Medical Officer, Dr. Shaun Carpenter, has been meeting directly with CMS and other MAC leadership to work collaboratively on a better scalable skin substitute reimbursement solution. The details of this solution was published in January of this year in Today's Wound Clinic and has a link at the bottom for providers to sign a petition indicating your support for the solution and the address of the CMS officials to email it to. Thank you for your time today.

Dr. Raeann Capehart:
Thank you. Next speaker. We move to the next slide, please. There we go.

Dr. Mark Spilker:
I'd like to repeat again the thanks to Noridian for allowing us to comment. I'm Mark Spilker, Dr. Mark Spilker, the Chief Scientific Officer at Geistlich.

Next slide.

I'm a paid employee of Geistlich Pharma, no other conflicts.

Next slide, please.

Today, I would like to request reconsideration for coverage of Geistlich Derma-Gide®, HCPCS code Q4302 in the proposed LCD for Skin Substitutes Graft/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

In the draft LCD, the Geistlich Derma-Gide® was listed in table two as a non-covered product with quote, no literature identified. This reconsideration request is based on the publication of level one clinical evidence in a 105-patient prospective randomized controlled trial. In this publication, the Geistlich-Derma-Gide® was referred to as PRBM, the purified reconstituted bilayer membrane, which is the generic descriptor for the product technology. You can see the screenshot from the publication on the right that PRBM is branded in the United States as Geistlich Derma-Gide®, which is processed by Geistlich Pharma AG in Switzerland.

Next slide, please.

The authors and clinical study team included Dr. David Armstrong, Charles Zelen, Dennis Orgill, and others as listed here.

Slide number five, please. Next.

The results of this prospective randomized controlled trial demonstrate that Derma-Gide is highly effective in the treatment of chronic diabetic foot ulcers, showing 85 to 92% closure rate at 12 weeks with a percentage area reduction of 93.6%, and this is compared to the standard of care alone, which had 45 to 67% closure rate at 12 weeks.

Next slide, please.

In addition to this statistically significant improvement in wound closure, the Derma-Gide also demonstrated favorable health economic outcomes as compared to similarly published data on other technologies that are covered by CMS. The mean graft cost of closure showed the lowest of the comparable technologies for which cost of closure data was published, and we request that such a study can be considered, reconsidered in the LCD.

Next slide, please.

In addition to this 105-patient randomized controlled trial, additional publications include a 40-patient interim analysis, a 10-patient observational series, and a 10-patient retrospective series, including deep wounds, as well as a material characterization manuscript that demonstrates the mechanism of action.

Next slide, please.

In summary, Geistlich requests reconsideration for the coverage of Derma-Gide in the proposed LCD. Geistlich places a high degree of emphasis on -

Jocelyn Fernandez:
One minute remaining.

Dr. Mark Spilker:
- gathering evidence to support these technologies, and we are pleased to send these solid outcomes about improved wound healing and the contribution to patient care. So we kindly request reconsideration on these grounds.

Thank you very much.

Dr. Raeann Capehart:
Let me make one comment. Now you're saying here that it is Q4203, but you repeatedly mentioned -4302. I am assuming, and I've just checked this with HCPCS, it is -4203. Am I correct?

Dr. Mark Spilker:
That's right. Sorry for the misspeaking.

Dr. Raeann Capehart:
Okay, just wanted to be sure we were clear. Okay, we'll move on. Thank you, sir.

Amanda Estapa.

Amanda Estapa:
Hi, good afternoon. Next slide.

Again, I would like to thank you for the opportunity to comment today.

Next slide.

My name is Amanda Estapa. I'm a Nurse Practitioner. I've been a nurse practitioner for 20 years, with 14 of those years being dedicated to the specialty of wound medicine. I'm Chief Clinical Officer, and you can see my bio here, which is not as important as the information I want to share with you today.

Next slide.

So my proposed LCD asks, are that we, number one, remove uncontrolled diabetes from the exclusion criteria. Number two, that you cover a minimum of seven skin substitute applications, and I'll share some important data in reference to that. And I would like you also to include retrospective studies as criteria for approved grafts.

Next slide.

So a little bit about our patient population. There's lots of demographics on this slide, average age, gender distribution, even racial disparity. But the important information is the information to the right of the slide, which is our patients are complex and have multiple comorbidities. And with that, 44.9% of our patients are diabetic. I want to point that out.

Next slide.

Which brings me to my first ask. To remove uncontrolled diabetes as exclusion criteria. Previous studies inappropriately excluded high hemoglobin A1Cs. We know that rapidly correcting a patient's hemoglobin A1C to within the controlled range of less than seven is dangerous and can take several months to achieve. So withholding a skin substitute while awaiting long-term normalization of blood glucose will only increase the likelihood of hospitalizations and amputations.

Our practice, under the direction of our Chief Medical Officer, Dr. Shaun Carpenter, has completed a six-year retrospective study on skin substitutes for hundreds of patients. And of our patients who healed with skin substitutes, 50% of those had a hemoglobin of A1C of less than seven, but 50% of those had hemoglobin A1C equal or greater than 7.

So how do you define uncontrolled diabetes? Is a hemoglobin A1C of 7.5 considered uncontrolled? Should we be addressing it the same as smoking? So, you know, what I recommend using is the same or similar language as you would, as you would address tobacco abuse. Something such as counseling on the risks of continued uncontrolled diabetes, et cetera.

Next slide.

I also ask that you cover seven skin substitute applications. Data reviewed in LCD only reflected hospital outpatient departments, HOPDs. These settings inadvertently treat smaller wounds due to the bundled payment. Smaller wounds inevitably require fewer applications. Our data in our retrospective analysis shows that greater reductions in wound sizes were based on seven or more applications. But what this slide does not display is that in this study, of the healed wounds, only 36.1% of those achieved closure after four skin-substitute applications. Conversely, 63.9% of those wounds were not healed after the fourth application. So what we did find, which is important, is that 74% of these wounds did heal after the seventh application, and this is real-world data.

Next slide.

So, my last ask is that we include retrospective studies for approved grafts. Like I said, my practice is currently overseeing retrospective studies for skin substitutes for hundreds of patients. It is not sponsored by a vendor. It is IRB approved and being peer reviewed. A reliance upon clinical trials has historically failed medicine and stifled innovation, and the 21st Century Cures Act calls on the use of real-world data. So, real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from the analysis of real-world data. So let's utilize real-world data to help guide our medical practice and improve outcomes in patient care.

Thank you.

Dr. Raeann Capehart:
Thank you.

Let us move on to David Farber. Mr. Farber, are you able to join?

David Farber:
Yes. Yes.

Dr. Raeann Capehart:
Great.

David Farber:
Can you hear me?

Dr. Raeann Capehart:
Yes, we can.

David Farber:
Okay. Thank you.

Good afternoon and thank you for holding this meeting and for considering our comments. My name is David Farber. I represent the Medicare Access to Skin Substitute Coalition, a group of skin substitute companies that are dedicated to ensuring access to critical wound care products.

Our coalition and its members are seriously concerned about the coverage policy set forth by the MAC and the draft LCD. We believe it's arbitrary and capricious, sets unclear standards, is inconsistent with FDA regulatory framework for skin substitute products, and is bad for patient care.

Next slide, please.

First, it is important to recognize that the CGS, Noridian, and First Coast MACs issued nearly identical final LCDs in the summer of 2023. You referenced that history earlier. As the MASS Coalition and other stakeholders voiced their concern about the policy then to both the MACs and to CMS, the MACs ended up rescinding those final LCDs before they became effective.

Here, not only did the MAC issue a draft LCD very, very similar to the one that was rescinded, but all of the MACs throughout the country followed suit, effectively issuing a National Coverage Determination or National Coverage Policy. We believe that that is procedurally improper. And even after rescinding the final LCDs last year, the MACs did not obtain stakeholder input with regard to the new draft LCDs. No Contractor Advisory Committee, no public meetings to obtain input on how to formulate a new policy. Instead, substitutively, we have the same policy that was rescinded last year, just packaged in a different way. We believe that's improper.

Next slide, please.

Now, the coalition products are, the products represented by the coalition members are predominantly HCTPs under Section 361 of the Public Health Services Act. And it's important to note that FDA would not consider HCTPs for amniotic or placental tissue products to be indicated for any purpose other than for serving as a wound cover or barrier. FDA would not consider an HCTP to be appropriately described as functioning as a skin scaffold.

Next slide.

While we appreciate that the CMS and FDA criteria are different, the draft LCD adopts a definition of skin substitute that requires a product to be a scaffolding for skin growth, inconsistent with how FDA views HCTPs. Again, the FDA TRG would not issue a letter stating that the HCTPs should function as a skin scaffold. I know not a requirement of this LCD, but still. The MAC cite the AMA codebook, but there is no clear rationale for the draft LCD regarding why the skin scaffold definition in the CPT codebook is even relevant to a Medicare Coverage Determination.

Next slide, slide five, please.

In addition, we believe that the draft LCD proposes coverage for only 15 products and puts over 200 products in the non-covered category. Again, the reasons are unclear. We've already heard that CMS has missed a number of important studies, and we think there are many other studies that are also missing.

Jocelyn Fernandez:
One minute remaining.

David Farber:
We will cite those in our written comments.

The scaffolding requirement is also not clearly defined. The distinction between covered and not covered products is arbitrary and capricious. There are products in the covered category that arguably provide scaffolding and other products that do not. There's no sense to it.

Slide six, please.

Similarly, the four-application limit is arbitrary and capricious. You've already heard from others, and we agree with those comments, that clinical experience shows that large and complex wounds require more than four applications. And the authors of the primary study upon which the MAC has relied have already stated that the MACs have misinterpreted their studies, and that happened last year, the MACs persisted in that misinterpretation.

Slide seven, please.

We also believe that if the draft LCD is finalized, Medicare beneficiaries will suffer. It is unreasonable to expect that only 15 products can serve the entire Medicare population. Treatment of wounds will be delayed if they are, if beneficiaries are treated at all.

Jocelyn Fernandez:
Thank you for your comments, but your time is up, and your line has been muted.

We will move to the next speaker.

Dr. Raeann Capehart:
Mr. Hunter, are you available?

Tim Hunter:
Yes, can you hear me?

Dr. Raeann Capehart:
Great, thank you.

Tim Hunter:
Well, thanks so much for the opportunity to present today. My name is Tim Hunter. I serve as the Vice President for Reimbursement and Government Affairs for BioTissue, and if you go to the next slide, BioTissue is the manufacturer of Neox® amniotic membrane graft products.

There are three products we'll talk about today, Neox® 1K, Neox® RT, and Neox® 100. Those are represented by HCPCS Q4148 and Q4156. The Neox® products for DFU and VLU are part of a bigger portfolio of amniotic membrane products that BioTissue manufactures. Other products are used for corneal ulcers in the eye. You may be familiar with our Prokera® and AmnioGraft® products.

If you go to the next slide, please.

When we designed the Neox® graft products, they were actually designed for less frequent application. Typically, they were designed for application every three to four weeks. And you can see in our illustrated product application guide, that this is the way we actually train physicians. You know, we would like for our product to be used in a way that it remains on the wound bed for three to four weeks. If it's there, we ask physicians to leave it alone unless there's a reason to replace the product.

And if you go to the next slide, what we see in the real-world evidence and outcomes is that the Neox® 1K, Neox® RT, and Neox® 100 can be used with less frequent applications very successfully in complex wounds. So whether you're looking at the Caputo study on the left or the Raphael study on the right, what we see are high rates of complete epithelialization. And we see an average time that's a little bit more than the 12 weeks that are described in the LCD, but we see an average number of grafts, somewhere around two. So sometimes it's one, sometimes it's three, very rarely is it more than four.

And so when we think about an LCD like the one that Noridian is proposing, we feel like the real-world evidence for this product fits very well with the proposed change in the clinical protocol. And again, we would ask that these products be included for use by physicians at Noridian, and certainly we'll be asking the other MACs to do the same.

And if you go to my final slide.

I think at the end of the day, Neox® 1K, Neox® RT, and Neox® 100 are all products that were developed to actually meet the protocol that you're attempting to establish. They've been used this way for many years. They've been used in the clinical community this way for many years, and what we see is that the evidence, including the two studies that we showed today, demonstrate really high healing rates, even in complex wounds.

And so from my perspective, it's hard to imagine that -

Jocelyn Fernandez:
One minute remaining.

Tim Hunter:
If Noridian is going to finalize an LCD with a four graft application, that I don't see why it would not include the one product group that was designed and is used like this right now.

So, I thank you very much for your time and look forward to the rest of the conversation.

Dr. Raeann Capehart:
Thank you, sir.

Dr. Niezgoda, are you with us?

Dr. Jeffrey Niezgoda:
I am here.

Good afternoon. I'd like to thank the Noridian team for the opportunity for all of us to present today.

Dr. Capehart opened with some interesting comments. She said the LCD defined wound care.

I am the Chief Medical Officer at Kent Imaging, and I want to say that Kent always has supported excellence in clinical practice. And we believe that NIRS is defining the standard of care, and we believe that NIRS supports not only the philosophy of excellence in wound care, but the approach to wound care.

The data and published studies demonstrate that NIRS has the ability to demonstrate adequate wound bed oxygenation, wound-based preparation, and more importantly, for the purposes of this LCD, the patient responds to applications of cellular, acellular matrix-like products or CTPs.

Next slide.

The LCD talks about arterial vascularization, and we know that ABIs are inadequate for evaluating vascular flow in multiple studies. Many times these are falsely elevated, especially with arterial calcifications, as we see in diabetics. This slide shows what we can accomplish with near-infrared spectroscopy, and it's a great alternative to ABIs would train at it. This demonstrates using a simple maneuver of lifting the leg and demonstrating flow, and we show what happens after that arterial flow has been corrected.

Next slide.

Also from the LCD, we suggest that ultrasound is recommended. The venous duplex ultrasound does not provide a diagnostic information. And these studies really create challenges for our patients and that many times, especially in the home care, mobile wound care setting, these patients have to be transported to the hospital. This delays care and really prevents them from these diagnostic procedures.

Next slide.

This slide, a study shows the efficacy of using NIRS in evaluating patients with venous insufficiency. We use our deoxy hemoglobin used to demonstrate not only the extent of vascular insufficiency, venous insufficiency, but the response to therapy.

Next slide.

Importantly for this LCD, as you can see listed, evaluations in size, healing progress, infection control, and the adequacy of debridement all are required. We believe that NIRS imaging is missing from the LCD, because we can demonstrate this.

Next slide.

This is a slide demonstrating pre- and post- debridement imaging with NIRS. And you can see following debridement, we can document that that debridement is adequate and has prepared the wound base very well from an oxygenation standpoint to support the grafting.

Next slide.

Also important for this LCD is to monitor the progress and response to the cellular, acellular matrix-like products. This is a slide demonstrating that fact. We can apply these grafts, and then monitor these patients prospectively to determine whether they are responding to the graft as intended. And this is very, very important.

Next slide.

So in conclusions, we believe that NIRS imaging -

Jocelyn Fernandez:
One minute remaining.

Dr. Jeffrey Niezgoda:
- which is an FDA-cleared CMS reimburse diagnostic vascular tool, should be incorporated into the LCD to be used as a non-invasive vascular diagnostic to evaluate the wound-based tissue oxygenation and tissue perfusion. We believe that NIRS eliminates barriers that can cause delay in diagnosis or access to care. And then we believe NIRS imaging ensures compliance with the LCD recommendations, so we urge you to include the use of NIRS imaging as an accepted diagnostic tool and wound progression tool for this LCD. Thank you very much.

Dr. Raeann Capehart:
Thank you, Dr. Niezgoda.

Dr. Tettelbach, are you available?

Dr. William Tettelbach:
I am. Can you hear me?

Dr. Raeann Capehart:
Great. Yes, certainly can.

Dr. William Tettelbach:
Yes. All right. So let's go to the next slide. Yeah.

Hey, my name is Bill Tettelbach. I'm here as the CMO for Restorix Healthcare. We give direct patient care as well as the President of the American Professional Wound Care Association. I appreciate giving the time to talk about this topic.

Let's go to the next slide for me.

Yeah, so one thing I wanted to, as has been touched on before, is that the four applications really is not supported by the Medicare, the Armstrong study, which as a co-author on, actually has other things that are not taken into consideration inside like complex wounds, if they become infected, this extended. And so this actually, when you, you know, increases the number, but actually you still reach completion or closure on these. And even when we look at our own data at RestorixHealth, we do not see where four applications. Now there is the operant with the XK modifier, and we will get to that next.

This just shows when you're looking at RTCs, generally the majority of these products, unlike those that are on, stay on three to four weeks, which is typically less than say 1% of the utilization across the board, you see that this is above four. So this, and within these RTCs, I want to mention that actually the A1Cs are above the cutoff points. And these studies actually show in diabetics that you get significant closure rates despite elevated. So I agree that the A1C stipulation needs to be removed.

Next.

So this is the Armstrong study, which was a co-author, and we were looking at this. Again, 3.7 does not necessarily take into account this data is just from the HOPD sites, hospital-based. It doesn't reflect private practice. It doesn't reflect post-acute care. And when you look at the MACs group next, the Proficiency Match 2 group, you can actually see, let's see the next slide. There you go.

You see you actually get better results that has been spoken to. There's less amputations, there are less minor and major amputations when you actually go even up to five. So the data, not saying it's five, but actually when you take one standard deviation, this should be seven or eight.

So let's go to next.

And the 12-week episode really does not match the data itself that you see in these studies, weekly or bi-weekly. So the question that is presented as well, if you take up the four applications within the 12-week episode, can you actually use a KX modifier within that 12-week episode or do you have to wait to the end, which puts the patient at risk for other complications?

Next.

So I think a six-week -

Jocelyn Fernandez:
One minute remaining.

Dr. William Tettelbach:
- eight-week with four applications would be where we want to be or not. But then there's another Medicare study showing that weekly applications, or bi-weekly, are far superior than the three-week period we're looking at now.

So let's go to the next.

And we, again, with the KX modifier, there's problems of we need examples. What constitutes actually improvement? So I think putting some examples but not limiting it to should be in the LCD.

So let's go to the next. Let's try to go near the end here. Next, next.

And then finally, I just want to say within the LCD, we need to be careful for patient harm. You say here, we should be using class three or more supportive compression, and say in venous ulcers, but this is 30 to 40. If you have an elevated ABI, you don't want to use that high. So you should need to like take into account, you need compression. But if you're going to say use 30, that's actually a patient harm issue. And then you also put suggested as a benchmark, and either or it isn't. So you need to fall, I think, on a very solid language that this is also acceptable, such as the near infrared or the like, a toe brachial index.

Next.

And these are just some of the examples we'll put you some of the comments. So thank you.

Jocelyn Fernandez:
Thank you for your comments, but your time is up and your line has been muted.

We will move to the next speaker.

Dr. Raeann Capehart:
Ms. Bliss, are you available?

Beverly Bliss:
I am. Thank you so much. Thank you for the opportunity to give our comments.

My name is Beverly Bliss. I'm the Executive Vice President of Regulatory and Quality for Pinnacle Transplant Technologies. We are a multi-service allograft tissue establishment that provides clinical allograft solutions for medical professionals in the treatment of patients with chronic wounds. Then the use of these skin substitutes for venous leg ulcers and diabetic foot ulcers has been an important advanced treatment for patients that have not resolved these wounds through standard of care. We are very thankful for the opportunity to provide this feedback today on this recently issued draft LCD.

I think you can go to the next slide, and the next slide, thank you.

So Pinnacle is committed to complying with the requirement to provide clinical evidence for the reimbursement of these products for VLU and DFU treatment. We do have some concerns in addition to some questions for your consideration, and thank you very much for allowing us to do this.

Our first concern, patients will have limited access to these treatments if the implementation date for the LCD does not allow for the completion of the clinical trials. We all know clinical trials can take a relatively extended period of time, and we believe that we would need that time in order to complete these trials. There does not appear to be a clear definition of the process that will be required to transition from non-covered to covered products, and the LCD moves 90% of the currently covered products to the non-covered products list, which would severely limit patient access.

We have some questions that we would also like to present. Can a common format be white labeled to multiple product names with multiple Q codes and only require a single study? And if so, will all these codes be reimbursed the same or will it still be ASP-based? How will CMS address reimbursement of skin substitutes for use in treating pressure ulcers? I believe that that was answered in a session earlier this morning, but we still do, would like the definitive response to that. And our last question is publication of the data required in order to be considered for reimbursement?

And I just have a couple of closing comments. I appreciate your extra time.

You can go on to the next slide.

For the Food and Drug Administration, the FDA, has already issued final guidance describing how tissue processors can legally market and distribute two primary product types, amniotic membrane and various skin products, which are defined within the framework of 21 CFR as human cells, tissues, and cellular and tissue-based products, otherwise known as HCTPs.

Based on our understanding of the proposed LCD, many cellular and tissue products, or CTPs, are excluded from separate coverage and reimbursement even when they are compliant with FDA's regulatory scheme and based on a determination that the CTPs are considered wound coverings or wound dressings rather than skin substitutes. As an American Association of Tissue Banks accredited tissue establishment, we agreed with their statements last year during the LCD hearing that this distinction was incorrect.

We contend that -

Jocelyn Fernandez:
One minute remaining.

Beverly Bliss:
We contend that many of the CTPs excluded from coverage are in fact skin substitutes. These allografts are often provided in the form of a sheet that is anchored to the wound with sutures, adhesive strips, or other similar mechanisms.

Finally, we note that patient access to CTPs is particularly important given the disproportionate impact of DFUs and VFUs in racial and ethnic minority populations. Latinos, African Americans, and Native Americans in particular have the highest incidence of DFUs in the nation. Limiting access to these important products may lead to greater disparities and worse outcomes for patients.

I think there's another slide, please, if you want to advance.

To provide sufficient time to address our concerns and protect beneficiary access to these important tissue products, we do urge CMS to allow a minimum of three years to complete the clinical trials, during which time we would like to ask that CMS additionally reconsider how products used for VLU and DFU should be managed in both the clinical and reimbursement systems.

And I thank you for considering these comments.

Dr. Raeann Capehart:
Thank you.

Ms. Ravitz?

Karen Ravitz:
Yes. Hi. Thank you so much. I appreciate it.

Good afternoon. My name is Karen Ravitz, and I'm the Health Policy Advisor for the Coalition of Wound Care Manufacturers. Founded in 2000, the coalition represents leading manufacturers of wound care products used by Medicare and commercially insured beneficiaries for the treatment of wounds, including cellular and/or tissue-based products for skin wounds or CTPs that are the subject of this policy. Thank you for the opportunity to provide our feedback on the proposed LCD and accompanying LCA.

The coalition appreciates that the MAC adopted many of the changes recommended by the coalition in our previously submitted comments, including but not limited to the ability for patients to obtain additional applications when medically necessary and documented. There are many areas in which we believe clarification is necessary and will provide those issues in our written comments as well as more substantive comments on provisions contained in this draft policy. But for the hearing today, I'd like to focus on three specific issues.

First, while we fully support evidence-based policies, more clarity is needed to better understand the evidentiary bar. For example, while it appears that the MACs are only providing coverage for products with RCT studies, there are several products that have RCT studies which are not covered. It also appears that the only RCT studies the MAC is accepting is for products that have applications within the policy parameters. The MAC has also indicated that coverage will be provided for CTPs having peer-reviewed published evidence, and yet there are products that have peer-reviewed evidence that are also not covered. There's no consistency in the evidence that is being accepted by the MAC, nor is there any transparency as to what metrics were utilized to review the evidence. As such, we would request the MAC be more transparent in its criteria for product coverage and publish what is considered an adequate trial design and outcome to gain coverage.

Second, we would also like to better understand the timeframe and process a manufacturer will need to undertake when submitting evidence for consideration. Does the manufacturer need to submit a reconsideration request in order for the MAC to review evidence for consideration of being placed on the group two list? Or since changes can usually be made to the LCA without going through the notice and comment period, which is why the LCAs were established in the first place, a manufacturer can simply submit their evidence for consideration and the MAC will review and place the product on a Group 2 covered list if the MAC deems the evidence to be satisfactory without going through the notice and comment period? If the latter is the case, how long will it take for the MAC to review and make a decision for inclusion? Will the decision include the rationale for either not placing or placing the product on a group two covered list?

We raised this issue, as in previous drafts, we've been told inconsistent messages and would appreciate clarity being provided. We would also like to know, excuse me, when Noridian reviewed evidence for this policy, what was the cutoff date, as there are recent studies that do not seem to be included in the evidentiary review for this draft policy.

And finally, we would also like to ensure that all of the 15 codes and corresponding products listed in the Group 2 covered product list are available for coverage and reimbursement for both DFU and VLUs. And I'm wondering if the MAC medical directors would be willing to answer that question today while we're all present and able to hear your response. As mentioned, the coalition will be submitting written comments with additional issues being addressed.

Jocelyn Fernandez:
One minute remaining.

Karen Ravitz:
Thank you. I was just concluding. Thank you for the opportunity to speak today.

Dr. Raeann Capehart:
Thank you, Ms. Ravitz. And now we'll proceed on to Michael Bain.

Dr. Michael Bain:
Hi, can you hear me? Hello?

Dr. Raeann Capehart:
Yes, we can. Yes, we can.

Dr. Michael Bain:
Thank you. My name is, thank you for the opportunity to speak. My name is Dr. Michael Bain.

I'm the Medical Director of the Hoag Hospital Wound and Hyperbaric Medicine Center in Newport Beach, California. I'm a treating physician. My disclosure is that I'm a speaker panel for Organogenesis. I'm a board-certified plastic surgeon. I see between 140 and 150 wound patients a week, about half of which are Medicare beneficiaries. My healing rates are tracked against 700 clinics across the country, and my healing rates have been found to be 25% faster than the national average. I've conducted research on skin substitutes and generated real-world evidence through registries including PuraPly® AM, that is a long-standing established treatment that is supported by evidence and works for patients.

I'm very concerned about the proposed non-coverage-approved and established products, specifically OASIS® Burn Matrix, the Smith & Nephew product, and PuraPly® AM, both small intestinal submucosa products. Non-coverage would harm my patients with chronic wounds who would be able to continue benefiting from currently covered products I've used for years. Both are very similar to other clear products, Oasis® Wound Matrix and Oasis® Ultra. The antimicrobial component of PuraPly® AM makes this a standalone product with no equivalent.

Regarding hemoglobin A1C's, limiting the A1C is not practical. Operating room surgical treatment is not canceled with a high A1C. These patients still go to the operating room, receive surgical interventions, and they will heal, although with a higher complication rate. Care is neither delayed nor withheld.

The proposed limit of four applications is also highly problematic and unfair. It would leave my sickest patients with the largest wounds at highest risk without enough treatments to heal. I was the lead author for the PuraPly® AM study discussed in the draft LCD as having promising results.

The Bain paper published in 2020 Journal of Comparative Effectiveness Research. The draft LCD recognizes that our group found that the treatment regimen allowed 73% of the wounds to close.

Dr. Raeann Capehart:
Dr. Bain, you seem to have been cut off. Can you hear me? A little bit back.

Dr. Michael Bain:
Okay, are you back?

Dr. Raeann Capehart:
Yes, now we can hear you.

Dr. Michael Bain:
Great, I'm sorry.

So the study was prospective with 28 sites, 67 of the wounds were venous leg ulcers, 62 were diabetic foot ulcers, 72% were over 65 years old, and the average wound site was just under 13 square centimeters, with the average seeing in my clinic of eight square centimeters. These were more difficult, larger wounds to heal, and yet they went on to heal.

The draft LCD criticizes the study as lacking in control, but my practice uses the burn literature as a paradigm debridements using a skin coverage to gain control of the wound bed. And I want to remind you that most of my patients are ASA 3s and 4s, and with a 30-day mortality, that is significant. We try to keep these patients out of the operating room.

The four applications is a burden to my staff. We are short-staffed as it is, and it would increase our costs to have people that work for us have to jump through hoops to get more grafts. If a median is four -

Jocelyn Fernandez:
One minute remaining.

Dr. Michael Bain:
- it makes sense that half of the patients would not be able to get care based upon those four, and you're putting an unnecessary burden on us as clinicians. I want to point out that draft LCD seems to derive its four applications from a large retrospective cohort of study claims data where the average number of applications was four. And it's problematic that the draft relies on non-randomized control data and proposing to restrict coverage for necessary care and fails to recognize the value of real-world evidence to support coverage of long-standing FDA clear products that help patients heal.

I want to agree with some of the past speakers that talk about how many of these patients would be excluded from prospective studies, because they would. These trials that take everyone that comes through, such as ours, picks the worst patients possible, and you see the results. I don't think it's right that care should be either discontinued or held while we are waiting for approval, especially when a patient's on a healing trajectory. This would result in stalled wounds.

Jocelyn Fernandez:
Thank you for your comments, but your time is up, and your line has been muted. We will move to the next speaker.

Dr. Raeann Capehart:
Ms. Nusgart, are you available?

Marcia Nusgart:
I certainly am available. Good afternoon. I'm Marcia Nusgart. I am the CEO of the Alliance of Wound Care Stakeholders. Thank you for the opportunity to provide the Alliance's concerns related to the release of the Skin Substitute/CTP LCD and the accompany LCA.

The Alliance is a nonprofit multidisciplinary trade association of physician medical specialist societies and clinical associations whose mission is to promote quality care and access to products and services for people with wounds through effective advocacy and educational outreach in the regulatory, legislative, and public arenas.

This oral statement was written with the advice of the Alliance Clinical Specialty Societies and organizations that not only presents expert knowledge in complex chronic wounds, but also in wound care research. We have several concerns with the current draft and areas we identified which needs further clarification that we'll address in our written comments. But I would just like to take the time right now to address three issues.

First of all, the proposed policy continues to permit only four applications of CTPs in a 12-week period of time. As opposed in previous drafts, Noridian is permitting additional applications and an extension of the 12-week period of time when medically necessary and documented in the patient file. The Alliance fully supports the proposed LCD language permitting additional applications or an extension of the 12-week period of time based on medical necessity with documentation provided in the patient's medical record. It's important that a patient be able to receive more applications when medically necessary, especially when their wounds are progressing. So the Alliance appreciates and supports it's clinically necessary and appropriate change from previous drafts.

Secondly, the Alliance also supports coverage based on evidence. We've always been on the record supporting evidence-based medicine. However, we're concerned that Noridian eliminated coverage for a significant majority of products in the market currently, many having evidence to support their use. As such, we believe that Noridian needs to be clear as to the evidentiary bar, as we believe that there are studies for products that were eliminated from coverage that should not have been. We're also aware of products that have evidence that were not identified in your list of products evidence that was reviewed. So what is the process for a manufacturer to submit evidence that does not appear to be reviewed? More information on the evidentiary bar and any recourse that a manufacturer has with respect to evidence review should be provided.

Finally, we would also like to urge Noridian that once this policy becomes finalized, given the limitation on the number of products that are currently on the proposed list of covered products, that there be ample time to implement this policy. Patients will be in the midst of treatment plans on products that may not be covered any longer. Their treatment plans are 12 weeks, and any changes to these treatment plans can negatively impact them.

Furthermore, facilities who do not use products on the proposed list of covered products will need to go through a formulary review process of the products that are covered to determine what they should be adding to the formulary. Realistically, this process could take up forwards to eight months. As such, we encourage Noridian to ensure that there's enough time to implement the provisions of the LCD once finalized, so to not negatively impact patient care.

I appreciate the time and opportunity to be able to speak with you today, and we will be submitting our written comments before the deadline in June. Thank you so much again.

Dr. Raeann Capehart:
Thank you. And we hope to address some of your questions, actually, at the end of this conference.

Our next speaker, I'm not going to try that one. Dr. Gunasekaran, are you with us? In-call cooperation, do we have any speaker from you?

Dr. Subraman Gunasekaran:
Yeah, can you hear me?

Dr. Raeann Capehart:
Yes, we can.

Dr. Subraman Gunasekaran:
Very good. I'm sorry, one second. Yeah, I had to wrap up the other presentation. See, unfortunately, CMS has declared at the same time with the three MACs, so I was just finishing the other CGS talk. So I have to work with the Nordian now.

Can you hear me now?

Dr. Raeann Capehart:
Yes, sir, and I may mention that any presentation you made to any one of the other MACs will be incorporated into the review of this. So if you would choose not to, there's no reason to make it a second time.

Dr. Subraman Gunasekaran:
Can I start my talk?

Dr. Raeann Capehart:
Certainly.

Dr. Subraman Gunasekaran:
Okay, good. My name is Subraman Gunasekaran. I am the President CEO, CTO of Encoll Corporation in California.

I hold a PhD degree in biological sciences, and I'm also affiliated with the Society for Biomaterials for over 40 years as an active member. In this scientific organization, I currently serve as a liaison, as well as the program chair of the SIG, namely Biomaterials and Medical Products Commercialization. Based on my interest and expertise in the field of biomaterials, during the mid-90s, I have been involved with FDA authorities to evaluate collagen-based biomaterials for the safety and effectiveness in the device applications. As an example, I had the opportunity to inform FDA team about the technical impossibilities of producing type one collagen using recombinant methods. I also played a significant role in establishing the ASTM for surgical grade type one collagen preparation.

Furthermore, I have collaborated with Dr. Grace Picciolo from FDA in the industry and regulatory group meetings, focusing on tissue-engineered products. I have also worked alongside Dr. Eric Sussman of FDA through the Society for Biomaterials. Together we have organized webinars to shed light on evaluating the medical device based on scientific relevance of the biochemical composition of the biomaterial. However, I have also been instrumental in organizing the few panel discussions emphasizing the commercialization hurdles of biomaterial-based regenerative medical products to address challenges in the field.

With all this expertise, I am here to provide my perspective on the recent LCD proposal. I do admit that I have a personal interest as a commercial product developer in understanding in the scientific and technical relevance of the current proposed LCD. In the interest, it is the interesting note that CMS and MACs have recently seemed to promote amniotic and placenta-based products as skin substitutes. The role of FDA to monitor the safety and the efficacy of such medical devices is highly, in fact, compared to the routine market clearance of a medical device using 510k or BMA grafts.

During the last LCD proposal by Novitas, First Coast, CGS MACs, it was decided to call for a TRG letter from FDA to properly recognize HCTP products. This decision was strongly objected by certain groups who argued that such decisions would dramatically affect the patient care, leading to the cancellation of the whole proposal.

Jocelyn Fernandez:
One minute remaining.

Dr. Subraman Gunasekaran:
Now there is another proposal which we all know right now we are talking about. This indicates that certain products based on their clinical study data can be included as approved. Unfortunately, such clinical study evaluation is not adequately guided by CMS. Please see some of the observations and possible solutions: Disparities in clinical outcomes, manufacturers sponsored studies may not be relevant to accept, several covered products clinical outcomes have been assessed under high-risk categories. Please see the issued proposal. FDA involvement in the assessment of safety and efficacy should be mandated.

The proposed LCD contains controversial statements that need to be clarified. No proper pre-announcement of the need on guidance of clinical studies provided to the manufacturers. In conclusion -

Jocelyn Fernandez:
Thank you for your comments. Your time is up, and your line has been muted.

We will move to the next speaker.

Dr. Raeann Capehart:
Dr. Berman, are you with us? Or may, Mr. Berman, I'm not sure.

Jocelyn Fernandez:
It doesn't look like he signed into the meeting, Dr. Capehart.

Dr. Raeann Capehart:
Okay, then let's move on.

Japa Volchok, are you with us?

Dr. Japa Volchok:
Yes, good afternoon.

This is Dr. Volchok from Wound Care Experts. We're a multidisciplinary practice here in Las Vegas, and I have a couple of decades of experience in the space.

Reviewing this proposed LCD and the process that has been used appears to be supplanting the National Coverage Determination process, and at the same time creating a denial for a necessary treatment for wounds that are not specifically allowed within that LCD.

The silence of the LCD as it pertains to other wound types, including pressure ulcers, in effect will create a denial of coverage for those types of wounds. Have seen this in the past with other LCDs that have come out when ICD-10 was introduced when changes to surgical debridement codes were introduced by the AMA. And it takes a couple of years to correct such an error, so I would implore the contractors to consider that and not remain silent on providing guideline framework for coverage of other types of wounds.

The other comment that I would present is in the LCD that's proposed, the methodology being used and the reference to published literature is, in effect, creating an approval for certain types of cellular-based products, or certain categories of cellular-based products, without specifically delineating that within the LCD. The contractors appear to be favoring one or two specific products by specific vendors, because those may have been on the market longer. They have more literature on them, but those particular studies that are being referenced were never designed or published to compare one product versus the other. And in fact, the technical bulletin that Snyder et al. published lists this specifically and concludes that really at the category level, there's strong evidence to support the clinical use of these products. And certainly, that has been our experience in our combined 100 years plus of caring for patients with wounds.

And so in conclusion, I would just raise to the contractors that they consider the clinical application of these products and how they're used in practice as reasonable and necessary. And if there is a medical economics reason for restricting care, that that be considered and legislated in a different process than the creation of a de facto National Coverage Determination that will deny coverage for many Medicare beneficiaries that are in need of a reasonable and necessary care process.

Thank you.

Dr. Raeann Capehart:
Thank you, Dr. Volchok.

Is Stephanie Hales with us?

Stephanie Hales:
Good afternoon, can you hear me okay?

Dr. Raeann Capehart:
Yes, certainly can.

Stephanie Hales:
Great, thank you so much for the opportunity to speak today regarding this draft LCD.

My name is Stephanie Hales. I am a partner at Sidley Austin, and I represent Organogenesis.

We want to begin, as many others have, by applauding the evidence-based approach reflected in the draft LCD. We will have more to say in our comment letter, but in our time today, we focus on five recommended changes to the draft LCD. These recommended changes are important to strengthen the draft LCD's evidence-based approach and to provide safeguards for appropriate patient access to medically necessary care.

First, any final LCD should recognize that favorable real-world evidence, or RWE, constitutes quality data representing a product's safety, efficacy, and positive clinical outcomes. FDA, NIH, and a significant body of medical literature recognize that RWE constitutes quality-supporting evidence. Importantly, RWE addresses health disparities, as it demonstrates efficacy and patient outcomes in populations that often are underrepresented in randomized controlled trials, or RCTs. RWE captures how care is administered to patients, which is often missing from the highly controlled environment of an RCT. RWE includes data from registries, health records, and other sources, and leverages claims data to evaluate the impact of treatments in clinical practice. Accordingly, any final LCD should cover products that have sufficient RWE support.

Second, any final LCD should specify clear criteria regarding the data and evidence required for a product to be covered under the LCD. A lack of clear criteria creates confusion. Consistent with our first recommendation, the criteria in any final LCD should specify that the evidence supports coverage when sufficient RCT data or RWE is available.

Third, any final LCD must expressly provide a process to ensure timely review of additional data and prompt implementation of coverage within 30 days following submission to the MAC of evidence sufficient for coverage. Right now, the draft LCD does not address whether and how coverage updates will occur. Failure to do so is problematic, as it would create significant patient access issues and undo delays.

Fourth, the number of permitted applications should be increased under any final LCD to ensure appropriate and medically necessary care for all patients, including those with large or complex wounds who are among the sickest and most vulnerable patients in our healthcare system. Failure to do so would result in denying medically necessary care to patients and exacerbating harmful health disparities in this space. Notably, the draft LCD itself recognizes the significant problem of health disparities that already exists in this area of wound care. Any final LCD should take steps to mitigate this problem, not aggravate it.

Fifth, appropriate implementation timing is critically important to address any final LCDs impact on patient access.

Jocelyn Fernandez:
One minute remaining.

Stephanie Hales:
Thank you.

Any final LCD should have a notice period of one year to ensure patients and providers can adjust to coverage changes. The proposed LCD would eliminate coverage for over 90% of the products currently covered in the skin substitutes market, which would significantly affect capacity and supply, as well as patient access to needed care. A one-year notice period would help ensure an appropriate amount of time for provider education and for manufacturers of covered products to ramp up production to meet patient needs.

We look forward to following up further with our comment letter. Thank you again very much for the opportunity to speak today.

Dr. Raeann Capehart:
Thank you for your comments.

Mr. Banerjee, are you available? I don't think we have you signed in.

Jocelyn Fernandez:
No, he has not signed in, Dr. Capehart.

Dr. Raeann Capehart:
Okay. Then let's progress on.

Alanna Wargula, are you available? Ms. Wargula?

Alanna Wargula:
Hi, sorry about that.

Dr. Raeann Capehart:
Okay.

Alanna Wargula:
I don't think I am going to say anything that hasn't been discussed already. I am a podiatrist and a wound specialist in Northern California at a small wound care center under the Providence umbrella.

And just to be efficient in time, I reviewed, I wanted to bring to your attention a article from the Journal of Wound Care, February 2022, cost effectiveness of dehydrated human amnion chorion membrane, allografts and lower extremity diabetic ulcer treatment. Essentially their conclusion was, as we all know, and many other papers have demonstrated, that when these tissues are used within 30 to 45 days as a standard of care, it reduces major amputations, ED visits, inpatient admissions, and overall reduced costs. Reduced cost per patient for one year is about $3,600. And over five years, they actually reduced costs by about a little less than $5,000.

So, that being said, going to your proposed LCD, under the section coverage guidance, I take issue with the implemented treatment plan demonstrating all the following. You mentioned something about, or you state debridement as appropriate to clean granular base. And of course, that's always our goal. But one thing that we all know when we work in the real world, is that many of our wounds that come in need the growth factors found in these tissues to develop the clean granular base. For example, a patient with thick fibrotic tissue doesn't have a clean granular base. We debride it as much as we can. And at a certain point, sometimes you will crosshatch that tissue, place the skin substitute over that. And within a few visits, you will see granular buds coming up through the cross-hatched tissue. Another example is with my partner, he has a great real-world example where he fenestrated a skull and using skin substitutes with growth factors, these amnion chorion tissues over time and multiple applications developed granulation over the exposed bone and healed the patient's wound.

Also moving on, limitations, in your section limitations per ulcer episode of care. Like everyone else, I take issue with the limitation of four tissue applications and then having to be reconsidered. This is going to slow down treatment in a patient that may only beginning to show improvement after four applications. This can limit the care by a week or two and not receive treatment.

Jocelyn Fernandez:
One minute remaining.

Alanna Wargula:
I also take issue with not being able to apply or restart tissue after a patient has a recurrence of a wound, because I treat a lot of plantar diabetic foot ulcers, and they frequently will come back because many of them are not candidates for surgery to remove bony prominences due to other comorbidities. Excessive wastage, obviously that's never our goal, but sometimes the wound will shrink between one visit to the next visit. And we don't know that that's coming, and that's the whole point of utilizing the tissue is that the wound is closing. So I would like this part to be modified or clarified.

Again, I take issue with your section on disqualifying people due to uncontrolled diabetes.

Jocelyn Fernandez:
Thank you for your comments, but your time is up, and your line has been muted.

We will move to the next speaker.

Dr. Andrew Rader:
Hello.

Dr. Raeann Capehart:
Dr. Rader.

Dr. Andrew Rader:
Yes, my name is Andrew Rader. I'm a doctor of podiatric medicine, and I serve as Medical Director at Memorial Hospitals Wound Care Center in Huntingburg, Indiana, where we specialize in the treatment of non-healing wounds, including diabetic foot ulcers and venous leg ulcers. We also provide this care through our private offices due to the rural nature of our practice.

And I appreciate the opportunity to share my views on the proposed local coverage decision, limiting Medicare coverage of skin substitutes used in the treatment of venous leg ulcers and diabetic foot ulcers. I am, though, surprised and concerned to see the proposed LCD that would so dramatically truncate options for both providers and their patients in the use of skin substitute products.

I do not think that a cutoff of Medicare coverage of skin substitutes to only include a little more than a dozen older products with RCT evidence acceptable to Noridian is wise or justified. This potentially sets a dangerous precedent requiring RCT evidence for any approved skin substitute effectively quashing further innovation that is in response to scientific discovery. This would be akin to only approving surgeries with RCT evidence where to date only a small fraction of surgeries performed have this level of evidence to support their use. Appendectomies, for example, do not have this level of evidence, yet they save countless lives every month. It's an extremely serious decision to limit skin substitutes in this way. It would prevent me from using the products that, based on science, I believe are best for my patients. I'm certain that it will place many other professionals who struggle with these wounds in a similar situation.

I think that significantly more input from providers, patients and experts should have been sought before introducing this proposal. For example, in my practice, I use a product called InnovaMatrix®. This device is unique in that it utilizes porcine placental tissue in a process that very importantly, effectively cleanses residual cellular material to create a medium that is very importantly mitigating the immune response while supporting effective tissue growth. This has been successful, where other products have failed for my patients.

This device is predicated on an earlier porcine-derived product that has at least six clinical trials demonstrating effectiveness, but it would now be excluded because it does not have its own trial. Excluding products such as this with clear real-world evidence and a sound basis for FDA approval is not in the best interest of our patients.

Jocelyn Fernandez:
One minute remaining.

Dr. Andrew Rader:
In addition to stifling continued medical innovation, this will likely extend the course of treatment for many patients. The consequence of this is more complications, including amputation in the Medicare population suffering from diabetes. This population is disproportionately individuals from under-resourced community challenged by a myriad of social risk factors.

It ignores many other sources of information that demonstrate efficacy, including real-world evidence found in retrospective studies as well as peer reviewed scientific literature. This includes a very large study previously indicated using Medicare data from 2015 to 2018 showing effectiveness and reproductions of amputations and emissions.

With regard to limitations on the number of applications a 12-week episode period, I do appreciate that the proposed LCD moves away from the hard stop at four that was previously proposed. This is more in alignment with the published research, and I do appreciate -

Jocelyn Fernandez:
Thank you for your comment, but your time is up, and your line has been muted.

We will move to the next speaker.

Dr. Raeann Capehart:
Jason Matuszewski, are you available?

Jocelyn Fernandez:
Dr. Capehart, it doesn't look like he has signed in.

Dr. Raeann Capehart:
Wait a minute, who do we hear? Did we hear anything in the background there? Mr. Matuszewski?

No, then let's go ahead and move on.

Jennifer Linsky:
Hello, my name is Jennifer Linsky, and I represent Legacy Medical in coordinating new product development, marketing, and commercial strategy.

Legacy Medical Consultants is a leading provider of allograft wound care products, which are used as wound covering and barrier membranes over chronic and acute wounds, including diabetic foot ulcers and venous leg ulcers.

I'm speaking today to encourage Noridian to reconsider the proposed LCD. The proposed LCD seeks to limit coverage to products that have demonstrated efficacy through RCT trials, these trials that are not required by the FDA or the Tissue Reference Group, nor have they historically been required by CMS. There is no reasonable rationale to exclude valued products that are used daily to improve patient outcomes, especially in the absence of data indicating a therapeutic disadvantage in the currently available products between those with RCT data and those without.

Importantly, the proposed LCD, if implemented as is, will put thousands of lives at stake, as shown in the preeminent published literature outlining risk of amputation and correlation to increased mortality. Furthermore, the LCD will disproportionately impact marginalized communities, such as African American and Hispanic men and women across the United States who suffer from limited access to care.

We are also concerned that the availability of products that would be covered under the proposed LCD would substantially undersupply the existing demand. The real-world consequence will be that a significant portion of patients who receive treatment under the current LCD will not have access to advanced treatment options and will experience less optimal outcomes, including infection, amputation, and even death.

If this proposed LCD is applied as a model across applications, including pressure ulcers and other wounds, we worry that the shortcomings of this LCD will translate to patient harm across a broad range of indications. Rather than severely limiting patient access to products under the proposed LCD, we recommend that Noridian reconsider the LCD to align coverage of similar products with the existing FDA regulatory standards.

Currently, all of Legacy Medical's products meet the criteria for regulation solely under the Section 361 of the PHS Act as defined in 21 CFR Part 1271, and all Legacy's products have received confirmatory letters from the FDA Tissue Reference Group to validate their regulatory standing. These products are currently covered under the CMS fee schedule under the existing LCD. LMC's products were used in the care of nearly 30,000 patients last year with no reported adverse events.

Based on our analysis, the proposed LCD would eliminate patient access to 93% of current allowed products, resulting in dramatic unmet patient need as these treatments become unavailable. We estimate that this could lead to a two- to five-fold increase in the preventable amputations for patients with DFUs, based on the data reported by Dr. Armstrong and colleagues in the Wound Care in July 2021, a study that the MACS used as a basis to the drafting of the formerly rescinded and newly proposed LCDs.

If the FDA determines that additional safety and efficacy data is necessary, LMC supports process that transparently outlines the need and the criteria for further efficacy.

Jocelyn Fernandez:
One minute remaining.

Jennifer Linsky:
And LMC seeks the MACs support in providing a period of flexibility to allow sponsors to demonstrate this data. Rather than severely limiting patient access to products under the proposed LCD, we recommend that the Noridian reconsider the LCD to align coverage of similar products with the existing FDA regulatory standards.

If there is a valid reason to proceed with these standards, we recommend that the Noridian reconsider the proposed LCD in any of the following ways. Number one, delay implementation of the proposed LCD for 24 months to allow suppliers to conduct RCTs similar to the approach that was taken with amniotic global products.

Number two, define covered products by a standard of evidence rather than defining them by name to allow companies to determine or demonstrate the biological equivalents and thereby complying with FDA safety and efficacy standards as well as meeting the clinical utility requirements outlined by CMS or continue under the current LCD. Whatever is decided, patient clinical outcomes must be prioritized in the process and decision making.

We appreciate the opportunity to comment on the proposed LCD and look forward to working closely with you to ensure that patients with diabetic foot ulcers and venous leg ulcers have access to treatments they need.

Thank you for your time and this consideration.

Dr. Raeann Capehart:
Thank you.

Dr. Toranto.

Dr. Jason Toranto:
Yes, good afternoon, everybody. Can you hear me?

Dr. Raeann Capehart:
Yes, we can, very well.

Dr. Jason Toranto:
Wonderful.

Hi, my name is Jason Toronto. I am a plastic surgeon in San Diego, California. I'm the chair of the Department of Surgery at Scripps La Jolla. I'm also a consultant for RenovoDerm, and I'm going to talk to you about three different elements. One, wounds in general and the definition of what the particular proposal limits to. Two, innovation within the space, and finally, the clinical application of these skin substitutes.

So, I'm going to start with wounds. The way that you started the entire proposal was to talk about the fact that this was going to be narrowed down to just DFUs and VLUs. From a plastic surgery perspective, this is somewhat interesting, because if you look at just two articles, which I looked up just while I was on this, one is Tending Coverage Using an Artificial Skin Substitute by Shores et al., and another, Donor Site Wound Healing in Radial Forearm Flap by Di Giuli et al., you'll see that skin substitutes are actually very efficacious in the setting of tendon exposure. And that applies to a much broader group of wounds.

So I was really surprised to see that this was so narrowly focused and only involved patients that were DFUs and VLUs, because there are lots of different wounds in which this is actually applicable. And it's within the plastic surgery world considered well known that when you have exposed structures like that, that you utilize skin substitutes. And that is what we utilize in the wound care space as well. So I found the limitation to be, frankly, too limiting.

Second, I'd like to talk about innovation. Part of the reason that all of this discussion is happening is because there's so much innovation in the space, which is absolutely wonderful. The key, in my opinion, is that we don't actually squander the innovation and, in fact, we support the concept of innovation. I agree with Dr. Hale's comment that there need to be defined research pathways, so that smaller companies that are developing products can actually be a part of the larger approved product list.

Phoenix™ Wound Matrix, which is one which is RenovoDerm's product, and the code is A2015, is one of those products that is currently working on developing the literature, has literature, but doesn't have RCT level literature, and you're hearing this common issue across the board.

It's important to allow for this disruptive innovation that is occurring in this space because ultimately what we all want is the best products that work as effectively as possible. It would be wonderful if we had a product that you could simply put on one time and it, poof, went away, but we all recognize that that isn't the current status, and we need to allow for space and time to get there. I also want to point out that this is critical.

If you use Integra®, for example, which I've used for a long time and I would consider in many ways to be the gold standard as it started everything, you also know that it has various problems, specifically with infection. This is something that the synthetics address. And I note that as you look at all of these different skin substitutes, there are different pros and cons. And as a physician, you have to be able to be subtle enough to appreciate the patient in front of you.

Jocelyn Fernandez:
One minute remaining.

Dr. Jason Toranto:
And you'll have the correct product for the correct pathology. Finally, I want to echo what Dr. Bain said that a lot of his patients were ASA three and four. That's what I see as well. And the predominant use in my clinic is the use of these skin substitutes to keep patients out of the hospital and out of the operating room. Limiting down to this group of skin substitutes is going to dramatically impact the ability of many people across the country to be able to do that.

I cede my time, thank you very much.

Dr. Raeann Capehart:
Thank you, Dr. Toranto.

And that concludes our speakers. I will ask at this point in time if any one of the three speakers who we were unable to locate have appeared or have come into the conference. And hearing none, I think we'll just proceed.

I want to thank everyone here for participation in Noridian's Open Meeting on Skin Substitute Graft Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. This meeting is designed to provide the opportunity for stakeholders to recommend changes, submit additional evidence for consideration, and present their concerns regarding the proposed policy. This is also an opportunity for the MACs to ensure the understanding of the draft LCD within the stakeholder community.

We certainly appreciate everyone who has participated, and we hope that you will follow our subsequent response to your comments. We also have identified some of the misunderstandings and some of the questions, and hopefully we can offer some further clarification.

The following bulleted comments are the main points that both Noridian and CMS would like to put forth as far as learned and continued to explore efforts on the part of this LCD. I'm not going to read them individually. They will be seen on our website, but we do hope that these concepts will pass on to those who are considering change, making recommendations for further review and reconsideration of these policies.

Since this is an evidence-based policy, future evidence that has not been submitted thus far or that we have not found supporting additional products, additional time, additional treatments for these products will have to go through the LCD reconsideration process. However, those submitted to us as a response to these comments certainly will be evaluated prior to finalization of this project.

One thing that I would like to make clear on the bottom, and I've seen this recommend, I have seen this referenced through several of our comments. This policy only addresses DFUs and venous leg ulcers for one reason. Those two entities are the only entities for which we find sufficient evidence to justify the use as a substitute graft. This does not say that these particular products cannot be used as dressings, which it does appear from our conversation today, a lot of them are being used as. So keep this in mind. And certainly, these are at the discretion of the individual Medicare contractor as far as payment. But remember, dressings are not paid separately. So this particular LCD is in no way restricting your use of these products. We are only supporting those and the application of those for which we have evidence to support beneficiaries, improved outcome for these particular entities. So we hope this provides a clarification regarding the intent of the policy, and we hope to continue to work with the stakeholder community to provide the best care for our Medicare beneficiaries.

Thank you all.

Jocelyn Fernandez:
In closing, I would like to communicate the next steps in the policy development process.

The comment period for the proposed LCD will remain open until June 8, 2024. All comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing. Written comments can be emailed 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, our Medical Directors will either finalize or retire their proposed LCDs.

Responses to comments will be viewable in the Response to Comments article. Please monitor our website or register for LISTSERV notifications to be informed of actions taken on our proposed LCDs.

Do any of the CMDs have anything else they would like to say before we end this meeting?

Dr. Raeann Capehart:
I have nothing.

Jocelyn Fernandez:
All right. This concludes our meeting.

Thank you for attending the Noridian Open Public Meeting.