Open Public Meeting: Multiple LCDs - June 26, 2025 - JE Part B

Taylor Canova:

Good afternoon, everyone and welcome to Noridian's Open Public Meeting. My name is Taylor Canova, and I am one of the Medical Policy Specialists at Noridian Healthcare Solutions. We will be presenting the following LCDs: Transurethral Waterjet Ablation of the Prostate, Superficial Radiation Therapy, or SRT, for the Treatment of Nonmelanoma Skin Cancers, and Lab: Special Histochemical Stains and Immunohistochemical Stains.

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 are registered to present will be allowed to comment on the proposed LCDs today. If closed captions are needed, please click the closed caption icon on the bottom right-hand corner of your screen.

For the presenters, you are being allotted 10 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. If you reach the end of your 10-minute time limit, your line will be muted, and we will move on to the next speaker to allow all registered commenters time for their presentations. Please speak clearly to ensure that the system will be able to translate into captions for display. And 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 be also submitted in writing. All written comments received will be recorded in the response to comments article.

I will now turn the meeting over to Dr. Moynihan for Transurethral Waterjet Ablation of the Prostate. Dr. Moynihan, you can begin.

Dr. Eileen Moynihan:

Thank you. And I had no commenters register for this meeting, but I would like to thank all of you who have worked hard on this policy over the years. Initially, this LCD was written by two contractors in collaboration. The other contractors adopted some form of the LCD over the years. Each had the exact same coverage criteria, but they differed in some other areas of the individual LCDs.

Several months ago, each of the contractors received a reconsideration request on one or two of the coverage criteria around the same time by the same entity. Since our coverage criteria were all the same, we decided to form a multi-MAC collaborative work group to review the reconsideration request in entirety and update the LCD where necessary.

We started with the updates that had been made by Novitas and First Coast as their updates had been very recent. We then reviewed any literature that was new since the end of the Novitas and First Coast reviews.

The final product affirmed many of the previous coverage criteria, even with the newer literature search. However, some coverage criteria were changed.

The restriction to use transrectal ultrasound to determine the size of the prostate gland was removed. We removed the voided volume requirement of a minimum of 125 cc's. Noridian had removed the upper age limitation for the service during a previous reconsideration of this LCD, but the others had not. For those contractors, the upper age limitation was newly removed. Noridian had previously allowed the procedure to be done with prostate volumes up to 150 cc's, but some of the contractors had not and for those there was a change.

The format was changed from the usual format, because there were so many coverage criteria that were subject to reconsideration. We thought this format might be more transparent and easier to read in the current layout.

I am hoping that the fact that I have no commenters on this call means that everyone is happy with the results of the process, at least temporarily. I look forward to any written comments that we receive. I will especially be happy to receive the ones that comment, "good job," since I chaired the work group.

Anyway, thanks again for your time and input, and Noridian takes its comments seriously and really appreciates the feedback.

And now I'd like to turn it over to Dr. Luke Barre for a discussion of Superficial Radiation Therapy.

Dr. Luke Barre:

Thank you, Dr. Moynihan.

So, welcome everyone to this section of the Open Meeting focused on Superficial Radiation Therapy for the Treatment of Nonmelanoma Skin Cancers proposed LCD.

My name is Dr. Luke Barre, and I'm one of the Contractor Medical Directors here at Noridian.

As we have a packed schedule, there were quite a few registered speakers, I will keep my opening remarks purposely brief.

As mentioned, this policy focuses on the use of SRT as well as variants, including high-resolution ultrasound guidance and electronic brachytherapy.

The covered indications and limitations are in the proposed policy, which is posted to the Medicare Coverage Database, but I will highlight that SRT is considered medically reasonable and necessary only for patients with basal or squamous cell carcinoma meeting the criteria set out in the policy.

I do want to thank all of those who registered to speak on this proposed policy. We recognize the time required to engage with proposed policies, and our process for writing follows an evidence-based approach, which continues to rely on subject matter experts and feedback from all stakeholders. So, I want to emphasize the importance of your feedback in crafting the best possible policies.

I also wanted to reiterate one point made during Taylor's introduction, which is that comments made today should also be submitted in writing before the close of the comment period. All written comments will be recorded in the response to comments article, and they are appreciated.

With that, I think we can move to our first speaker, which I believe is Dr. Ankit Agarwal. Your line should be open, and I'll pass it over to you.

Dr. Ankit Agarwal:

Great, thank you. My name is Dr. Ankit Agarwal. I'm a radiation oncologist. Thank you for the, you know, folks who wrote this LCD and thanks for your time.

We can go to the next slide here.

So, these are my disclosures. I am a radiation oncologist employed by Western Radiation Oncology. I do currently use both IG-SRT as well as electronic brachytherapy my clinical practice. And I am employed by a couple of dermatology practices and do both SRT and EBT in multidisciplinary practice.

Next slide, please.

So, here's just an outline of a couple of main topics I want to talk about.

So, first is electronic brachytherapy. And specifically, my view is that there's really not a lot of a clinical or physics rationale to restrict electronic brachytherapy coverage. If SRT is covered, I believe they are clinically equivalent with some minor differences in machines.

Secondly, is ultrasound guidance. I do think that's a current standard of care. I do think improves treatments for patients who are receiving SRT, and I'll go through some data and some cases for why I think restricted access will hurt outcomes in access.

And lastly, in terms of radiation oncology supervision, I do largely appreciate and agree with the changes that either a radiation oncologist or an appropriately directed dermatologist is important for a safe and effective treatment delivery of SRT or EBT.

Go to the next slide, please.

So, I wanted to give a brief overview for folks who may or may not be familiar with SRT and EBT, what the differences are. You know, both deliver between 50 and 100 kilovoltage of radiation therapy to the skin surface. As a result, they both have identical depth-dose profiles in tissue, meaning the radiation dose penetrates and falls off within the distance, within the depth of this tissue similarly.

So, there's really no physical rationale, physics rationale to differentiate between SRT and EBT in clinical practice. In practice, machines are marketed as SRT or EBT based on their FDA approval, but folks who actually are in practice doing SRT and EBT know that in terms of the clinical impact on patients, really no difference.

Next slide.

So, I wanted to drive through some specific examples. This is a device, Xstrahl, that markets itself as a SRT and an electronic brachytherapy machine by simply using different applicator attachments. Specifically, this device uses an applicator that's five centimeters source of service distance as well as one that's six centimeters source of service difference. And this is a commissioning report from an Xstrahl machine that I'm involved with.

And bottom line, what you can see is that in 0.64 seconds for a 10 one centimeter cone, two grays delivered versus an SRT machine where there's a little bit of a centimeter longer applicator, it takes 0.94 seconds to deliver the same dose. But essentially, this is a pilling difference, to be honest. There is no physical difference for how the radiation's generated. There's no difference for how the radiation dose falls off in the patient.

And so, my view is that I don't even talk to patients about SRT versus EBT. I tell them they're receiving surface radiation therapy, and it just happens to be whatever device that the clinic happens to have in their clinic.

Next slide.

One of the points that some folks make is that, you know, electronic brachytherapy has a higher dose rate than superficial radiation therapy and needs more supervision.

And the reality is actually, you know, I again use Xoft and Sensus devices. And actually the Xoft device, which is just an electronic brachytherapy device, has a lower dose rate for a similar, let's say if I'm using a two centimeter cone prescribing three gray, it takes longer to deliver that dose with a Xoft electronic brachytherapy device than it takes with a Sensus SRT device.

So essentially, they are both, if you're using 50 kilovoltage SRT device or 50 kilovoltage in an electronic brachytherapy device, you can deliver the same dose to the same distance for the same diameter tumor. It's just a matter of which machine you use here.

Next slide.

So, you know, there are some misconceptions in the LCD.

In my view, the clinical rationale present in the LCD for treating SRT and EBT differently, such as different tumor size limits or outcome assumptions, frankly displays a lack of understanding of the physics and clinical implications of using a 50 to 100 kV at the skin surface.

The reality as we've discussed is that the clinical results are the same for SRT and EBT used for the same indications. Physicians such as myself, who have had experience with both, use them interchangeably in terms of how I select patients, prescribe doses, and fractionate treatments. There is no scenario where I would choose a different regimen just because a machine is called EBT versus SRT. The choice of modality is often driven by practical considerations, not by the machine.

So, you know, I would frankly, this is not within the means of this LCD, but I would, you know, suggest we do have a combined CPT code for SRT and electronic brachytherapy rather than eliminating coverage for electronic brachytherapy.

And, you know, the reality is there are some patients who, for example, you know, I saw recently a gentleman who had a lesion on his back. It was a basal cell. He's had multiple different surgeries. He's on a blood thinner, doesn't have anyone to take care of him at home. Really surgery wasn't a great option for him. He didn't want it again. You know, we had an SRT machine. I did eight fractions of SRT for that patient. You know, so I did a very few number of SRT fractions for that patient. He did great. You know, had a little bit of hypopigmentation afterwards, but did great.

I had another patient in another clinic where we had an electronic brachytherapy machine. It was a lady with diabetes and hypertension, a lesion on the lower leg, you know, on top of the shin where I really don't want to do eight fractions because I think that they will develop a non-healing wound ulcer. And so I did 15 fractions and prescribed to the surface rather than prescribing that one or two or three millimeters for that patient with that lower extremity lesion and the patient also did great.

So, you know, I think the argument that some folks use that electronic brachytherapy is fewer fractions and SRT is more fractions, it's just really practice patterns, not really grounded in clinical reality.

Now, there are some states within the Noridian sphere of influence, like Nevada, for example, that only register machines as electronic brachytherapy. So regardless of whether you treat, you know, pick an SRT machine or an EBT machine, they're registered as electronic brachytherapy. And then there's some states that do differentiate and have, you know, more regulations around electronic brachytherapy.

But I think, again, this is driven by a lack of understanding of the difference between the two, which in my view, there's very little, rather than any kind of real clinical or physics rationale.

Next slide.

Now let's shift to the use of ultrasound guidance in superficial radiation therapy. This is a use of high frequency ultrasound imaging to do the the planning and through the course of radiation. In my practice, I did not do ultrasound for many years. And then recently with emerging evidence, I have been using ultrasound and see the value. You know, for example, a nodule or basal cell that might be 2.5 millimeters deep, if we can monitor that before treatment and throughout treatment, that meaningfully affects my radiation dose.

The reality is with SRT or EBT, the dose fall off with a 50 kilovoltage machine is about 10% per millimeter. So for a patient, I typically look at the percent depth dose tables and for a patient with a deeper lesion, I might prescribe a three-millimeter depth versus for other patients, I might prescribe to surface. And what that means is a 30% difference in radiation dose I'm prescribing to the patient's surface. So it's very, very different.

And then throughout the radiation, depending on how they do, I may dial back or dial up the radiation therapy, which has a meaningful impact on the patient's, essentially outcomes, toxicity, side effects, efficacy, et cetera.

Next slide, please.

So there are multiple studies, of course, published between the 2020 to 2025 period.

I won't really go into these because I'm sure many of the other speakers will with 2,000 patients, 20,000 patients showing the outcomes of IG-SRT.

Really my point is that I think --

Taylor Canova:

One minute.

Dr. Ankit Agarwal:

-- There's a lot of data out for IG-SRT. It's actually more stronger data than data for surface guidance, for radiation or proton therapy for prostate cancer. A lot of things that we do without randomizing it on other spaces.

Next slide. We'll skip this slide, please. Next slide. Next slide.

So, you know, one of the points that the LCD made was that Mohs should be the first line therapy. The reality is I've treated family members with SRT.

You know, this is a patient with nodule or basal cell cancer on the tip of the nose. You can get a Mohs surgery, have a great long-term cosmetic impact. You can do radiation therapy with, in my view, less of a cosmetic impact short-term and less healing time. If it were me or a family member, I would choose image-guided SRT or EBT for these patients.

Next slide.

So in conclusion, you know, I think there's restricting the use of IG-SRT or EBT will lead to a decrease in utilization but also lead to a limitation of this and may shift patients to, in some cases, more expensive hospital-based electron therapy machines as well. So I do think continued coverage for this with appropriate supervision would be prudent.

Thank you.

Dr. Luke Barre:

Thank you, Dr. Agarwal.

I think you timed your presentation perfectly, and we do really appreciate your comments.

We'll now call on Leaton Pang. Please, the floor should be yours, and I'm looking forward to hearing you.

Dr. Laeton Pang:

Thank you.

So I'm a Radiation Oncologist in Honolulu, Hawaii. I am also the MEDCAC representative from Hawaii and the American College of Radiology MEDCAC network chairperson.

I do not have any personal experience using high-resolution ultrasound for treatment of superficial skin cancers, although we do radiate patients for superficial skin cancers and has been pointed out, radiation therapy is very effective for treatment of superficial skin cancers.

The variance does depend on location, the size of the tumor, the grade of the tumor, whether there's perineural invasion and the site of the primary where it's involved.

I would say that from an organizational standpoint, we did review this, and we did not feel that there was evidence to support the daily use of high-resolution ultrasound for superficial radiation therapy.

I appreciate the comments of the prior speaker, and I would be happy to look at evidence that he alluded to, but we did not feel that it was necessary to do that on a daily basis.

We have a comment letter from ASTRO that was submitted to NGS on a very similar policy in that region. If necessary, we can ask that that also be sent to Noridian.

Those are the only comments that I have to make.

Dr. Luke Barre:

Thank you very much, Dr. Pang.

Because it's a multi-MAC work group, that letter would likely be shared. We would, of course, welcome it if you send it to Noridian as well, though those really one comment submitted to one MAC should be shared with all of us. And we do appreciate your comments on the policy.

The next speaker is Dr. Sumaira Aasi. The line should be open for you, and you should be able to speak.

Dr. Sumaira Aasi:

Great. Can you hear me?

Dr. Luke Barre:

Yes. Yes, we can.

Dr. Sumaira Aasi:

Okay, wonderful.

Good afternoon, everybody. My name is Sumaira Aasi. I'm a Mohs surgeon and director of Mohs and Derm Surgery at Stanford University. I also served as president of the American College of Mohs Surgery, and I'm grateful for this opportunity to comment on the LCD for IG-SRT.

Can I have the next slide, please?

The American College of Mohs Surgery supports the LCD as written for several reasons. The proposed LCD sets reasonable safeguards for patients seeking treatments for skin cancer. It is similar to LCDs for Mohs Micrographic Surgery.

Skin cancer is prevalent, and its incident continues to increase. Therefore, LCDs for skin cancer must critically evaluate the data presented and protect patients from unproven and medically unnecessary services and protect CMS from abusive billing.

Next slide, please.

A recent peer-reviewed publication in the JAAD, the Journal or the Dermatology Journal with the highest Impact Factor, demonstrates a significant increase in the utilization of SRT and IG-SRT.

Next slide, please.

So, with IG-SRT, we're dealing with CPT for radiation therapy as well as additional CPT and cause for the ancillary services.

Next slide, please.

This table is from the article I just referenced. Please note the over 233% increase in the use of radiotherapy with ultrasound guidance. This growth in a service with unconvincing and unproven benefit has far outstripped the growth in skin cancer incidents. This dramatic growth highlights a need for an LCD.

Next slide, please.

So why do we support the proposed LCD? Because it is based on comprehensive literature review that demonstrates superficial radiation therapy is not first-line therapy for skin cancers, as previously stated. The use of SRT is considered reasonable for low-risk basal cell and squamous cell carcinomas when patients are not surgical candidates.

IG-SRT is no better than standard SRT. The current LCD requires documentation on why SRT is being utilized given that it is not first-line therapy. This is logical. Interventional therapies often have appropriate use criteria to justify their use. Thus, the LCD does not restrict SRT when it's clinically indicated. It will only correct long-standing inappropriate use of IG-SRT.

Next slide, please.

Hopefully, everyone on this call knows that physicians rely on evidence-based data and organizations such as the NCCN when making decisions for cancer treatment. The NCCN is a non-profit alliance of 33 leading cancer centers. It is a multi-specialty, non-biased authority that has a rigorous systematic process to regularly and comprehensively review evidence-based literature and expert consensus.

The NCCN guidelines are the recognized standard for clinical direction and policy in cancer care and are the most thoroughly and frequently updated clinical practice guidelines available in any area of medicine. I know, I serve on those panels. As you can see on this slide, the NCCN offers multiple options that can optimally treat low-risk basal cell. So why are we seeing this trend towards the most expensive option?

Next slide, please.

I'm going to skip this one for the sake of time. Go on to the next slide, please.

The LCD states that the use of high-resolution ultrasound to guide SRT and assess lesion reduction is not considered reasonable or necessary and is not supported by the literature. We agree.

I also want to reference a peer review article just accepted to the publication by the Journal of the American Academy of Dermatology. Again, the journal with the highest impact factor in derm. I became aware of the publication after these slides were submitted. The data presented in that study shows, the data presented in that study allows the authors to conclude the following, something that my previous colleague just also alluded to.

IG rarely prompts refinements to the dosing protocol throughout the SRT regimen. Given that common IG-SRT regimens involve 20 fractions, our findings suggest that IG is performed at most fractions but only prompts a dosimetry calculation of 1.03 to 1.23 per regimen with one mandatory calculation occurring at treatment onset.

Although image guidance may aid in the initial calculation and help exclude deeper or poorly defined lesions from receiving SRT, it likely provides extremely limited additional value during subsequent fractions at a substantial cost.

Next slide, please.

Proponents of IG-SRT repeatedly say that the proposed LCD is failing to consider new literature that shows a superiority to SRT and why it should be first line therapy. But newer is not synonymous with high quality, nor is it convincing necessarily.

Next slide, please.

The reality is that there are no perspective randomized controlled blinded trials comparing IG-SRT and SRT. All the publications are in low quality pay-to-publish journals. You have studies that quote a 99% cure rates, but the devil is in the details. Tumors lost to follow up are considered cured.

So when does a 99% cure rate, what does a 99% cure rate mean when 85% of those tumors are lost to follow up at four years in one study and 98.6% of tumors are lost to follow up in five years in another study. What compelling or valid oncology study that impacts treatment selection counts loss to follow-up as cured? The glaringly obvious conclusion is that poorly designed studies were published in low-quality pay-to-publish journals.

Next slide, please.

As someone in academic medicine who is responsible for teaching students, residents, and fellows about proper trial design, meaningful statistical analysis, and as a reviewer in flagship journals in the field of dermatology, there are critical attributes of a word study. Is it randomized? Is it prospective? Is there a control group? Are there blinded rigorous review? Are there serious conflicts of interest? If these criteria are not met, the studies do end up in low impact factor journals when one must resort to pay to get their work published.

Next slide, please.

This is one of the primary articles that proponents of IG-SRT cite. Look at the criteria missing. Not randomized, not prospective, no control group, retrospective with no standard protocol and no standard adverse event reporting. And guess what's also missing? The most nominal follow-up, not even a full year for 45% of the tumors.

Next slide, please.

Freedom from recurrence are strong words in the world of cancer. The question really is, if you were convinced you had a modality to cure cancer at unsurpassed rates, and these claims were valid. Why would you not spend time, effort, and resources to conduct rigorous studies that would not only be welcomed as publications in the most reputable oncology journals, but also impact thoughtful decision-making from key, non-biased, guideline-setting stakeholders like the NCCN?

Next slide, please.

How can you claim that ultrasound helps decrease toxicity and increase efficacy when there is no comparison to measure against? Such scientifically unsound conclusions would never pass muster in journals with scrupulous review.

Next slide, please.

There is simply no validated tool or study that tells us what ultrasound findings mean clinically or histologically.

Next slide, please.

Let's not forget that skin cancers that are amenable to superficial radiation therapy are without extensive dermal involvement. We have zero clarity on what exactly ultrasound guidance is providing for SRT.

And now we have a peer review study that demonstrates that image guidance is making no difference in guiding therapy with each radiation treatment, just increasing costs. Superficial, low-risk skin cancer is amenable to SRT. The LCD does not restrict access to SRT. LCD only restricts the unproven and expensive IG-SRT.

Next slide, please.

At best, ultrasound guidance can be considered experimental.

I live in Silicon Valley. My highly educated, but misinformed patients request a full body MRI and multiple tests every year. But just because we can do something does not mean we should do something.

Next slide, please.

This dramatic growth with such limited evidence suggests that factors other than patient outcomes are driving growth.

Next slide, please.

IG-SRT is designed for internal cancers, such as prostate cancer. This is dermatology skin cancer where external landmarks are reliable.

Next slide, please.

There are costs associated with it that I'm not even sure are being used when you're doing ultrasound guidance SRT for skin cancers.

Next slide, please.

We agree that we should have proper qualifications and not anyone should be getting access to a machine and using radiation therapy.

Next slide, please.

Taylor Canova:

One minute.

Dr. Sumaira Aasi:

The ACMS agrees with the statements about electronic brachytherapy as written in the LCD.

Next slide, please.

The proposed LCD will help the conscientious provider. It does not restrict SRT for patients when medically necessary.

Next slide, please.

In summary, the ACMS supports the LCD as written because it will not restrict but rather will ensure access to superficial radiation therapy in appropriate tumors and patients. The ACMS supports this modality in appropriate clinical scenarios.

The LCD will eliminate medically unnecessary and scientifically unsupported image guidance. It will safeguard patients from medically unnecessary and abusive billing of ultrasound services and potentially other related services. I can think of no reason why honest parties would object to this very reasonable and modest LCD.

Thank you for my time.

Dr. Luke Barre:

Thank you very much, Dr. Aasi.

I want to reiterate for all speakers that if you do have any additional comments or studies that you would like us to consider, if it is submitted in writing, it will be included in the response to comment article.

The next speaker is Dr. Alexander Miller.

I know that there were some technical issues earlier with the audio check. Dr. Miller, are you able to speak? The line should be open for you.

Dr. Alexander Miller:

Do you hear me now?

Dr. Luke Barre:

We do, yes.

Dr. Alexander Miller:

Okay, thank you very much.

Am I ready to start? Here we go. So, I am Alexander Miller. I am a dermatologist, board certified member of the American Academy of Dermatology. I am also a California representative to the Contractor Advisory Committee, Noridian that is, and have been for years. I am speaking on behalf of DermCAC. DermCAC is a national coalition of dermatologists who represent their state dermatologists.

Consequently, I am speaking for the unified dermatology representatives to various medical Medicare Administrative Contractors, but specifically I am speaking to Noridian today. And I have no conflicts of interests that are, well, period, I don't have for anything.

Now slide two, please, the next slide.

We appreciate you giving us a chance to speak and we would like to note and accentuate certain facets that I'd like to talk about.

The first is that we support the proposed LCD coverage of SRT as a secondary treatment for nonmelanoma skin cancer when surgical intervention is contraindicated or declined. And second, that we as DermCAC, that is, I am speaking on behalf of the DermCAC unified members, supports inclusion of dermatologists as qualified to furnish SRT for nonmelanoma skin cancers.

But we do recommend some changes to the requirements for demonstrating training and expertise in order to preserve patient access to appropriately qualified and trained dermatologists. And I'll provide extra details in my comments.

Next slide, please.

So the first is support for SRT as a secondary treatment.

This type of approach and this qualification for SRT is consistent with current evidence and specialty society guidelines, specifically from the American Academy of Dermatology clinical guidelines. And these guidelines do point out that surgery is the most effective treatment for basal cell carcinoma and squamous cell carcinoma with some few exceptions.

We also note that Mohs surgery is safe and well tolerated, even among high-risk populations, including the elderly, immunosuppressed, or medically complex patients.

Consequently, non-surgical candidates represent a relatively small subset of the overall nonmelanoma skin cancer population. At the same time, evidence reflects that SRT is reasonable and necessary in select cases, thereby supporting coverage of SRT as a secondary treatment option.

We do appreciate that Noridian comprehensively reviewed available literature, and we support the coverage decisions that reflect the current state of clinical evidence. We also encourage continued reliances on future best available data.

Next slide, please.

Now, we do recognize and appreciate that the inclusion of language outlining examples of clinical scenarios that may qualify a patient as a non-surgical candidate, because those would be very helpful. That is, who would be, according to the LCD, a candidate for SRT? And those would be such as potential functional impairment, significant morbidity, poor cosmesis, et cetera.

Now, we do highlight that physicians should collaborate with patients to consider factors such as cure rates and long-term clinical outcomes. These have been discussed by some of the other presenters. And we should consider maintenance of normal anatomy function and patient preferences in deciding on the course of treatment.

We appreciate that the proposed policy supports SRT as an option in the treatment armamentarium, as it should.

Now, next slide, please.

The LCD states use of high-resolution ultrasound to guide SRT delivery to assess lesion reduction during the superficial radiation treatment protocol is not considered reasonable and necessary and is not supported by literature.

We do acknowledge that it's an emerging area of technology, and we feel that the current published evidence on image-guided SRT does not allow definitive determination of the value of image guidance during the course of SRT. We do anticipate reviewing further scientific literature as it continues to develop, and we do encourage continued reliance on best available high-quality data.

Next slide, please.

And this particular slide highlights our support for dermatologists as physicians qualified to furnish SRT. The DermCAC, that is our unified collection of dermatologists representing dermatology to various Medicare Administrative Contractors, supports inclusion of dermatologists as qualified physicians to perform SRT.

We believe that this policy, as proposed, reflects dermatologists' longstanding decades of expertise in diagnosing and treating nonmelanoma skin cancer, including comprehensive understanding of skin anatomy and oncology, which has been gained through residency and fellowship training, as well as through ongoing clinical experience and continuing medical education.

Dermatologists have a long history of furnishing SRT under the Medicare program, and the Medicare claims data demonstrates that the majority of SRT services for nonmelanoma skin cancers are furnished by dermatologists. We also highlight that the inclusion of dermatologists as qualified to furnish SRT supports patient access, continuity of care, and positive outcomes. And in addition, since dermatologists are trained and capable and proficient in dealing with any potential skin changes consequence to SRT, we are fully able and trained to handle those particular outcomes.

Specifically, we are streamlining the diagnosis and the treatment and follow-up within a single office under dermatologist management, rather than splitting it into various locales and various offices.

Finally, by allowing dermatologists to furnish SRT, the proposed policies establishes a broader pool of qualified physicians able to furnish SRT. Restricting this access from dermatologists could create barriers to care and limited access to cost-effective and timely treatment for nonmelanoma skin cancer patients.

Next slide, please.

And we are concerned that the proposed policy requires dermatologist training and expertise to have been acquired within the framework of an accredited residency and or fellowship program. This kind of approach is flaws for numerous reasons. To begin, it unnecessarily includes qualified dermatologists restricting access to care.

Taylor Canova:

One minute.

Dr. Alexander Miller:

It also doesn't reflect current clinical practice, as many dermatologists did complete the residency before the emergence of newer current SRT technology. The LCD fails to recognize all other avenues for training such as continuing medical education, post-graduate fellowship training programs, and hands-on experience.

And specifically, if all coverage clinical services for other entities were limited to what we learned in residency or fellowship, new advances would be limited in scope and applicability.

For all of these reasons, the DermCAC recommends that Noridian finalize coverage for SRT as a secondary treatment for patients when surgery is contraindicated or declined and finalize inclusion of dermatologists as qualified physicians eligible to furnish SRT.

And that is the last slide. Next slide, please.

So we ask that the training and expertise requirements be revised to acknowledge and include dermatologists. Thank you for considering all of my comments.

Dr. Luke Barre:

Another perfectly timed presentation. Thank you, Dr. Miller, for your comments.

And the next speaker is Dr. Lio Yu. The line should be open for you and the floor is yours.

Dr. Lio Yu:

Can you hear me?

Dr. Luke Barre:

We hear you.

Dr. Lio Yu:

Yep, great. Hi, first slide please.

Good afternoon, everyone and thank you for the opportunity to speak today. My name is Dr. Lio Yu. I'm a board-certified radiation oncologist with over 30 years of clinical experience. I'm also the chair of research for the Dermatology Association of Radiation Therapy and lead author on several of the largest contemporary studies on IG-SRT.

Next slide, please.

Just to briefly introduce myself, I trained at Yale in molecular biophysics and biochemistry and completed radiation oncology training at institutions, including Mount Sinai, Memorial Sloan Kettering, Dana Faber, and Montefiore. I now serve as clinical director of radiation oncology and chair of research at DART and have authored multiple peer-reviewed studies on skin cancer, head and neck cancer, and radiation therapy protocols. Recently, I've led some of the largest IG-SRT studies in the US, analyzing over 20,000 lesions. I also consult with industry and strongly support transparent data-driven policy.

Next slide.

I want to speak today, as both a researcher and a clinician, IG-SRT is revolutionizing how we treat nonmelanoma skin cancer. Yet, the current draft LCD fails to recognize this. It conflates legacy SRT with modern IG-SRT, which is a technology that includes daily dermal ultrasound guidance. That's not a small difference. It's the difference between static treatment and real-time adaptive care.

Next slide.

We published the data showing greater than 99% freedom from recurrence across all major risk groups, basal cell and squamous cell carcinomas, squamous cell carcinoma in situ, all with greater than 99% control rate. Equivalent results in patients over age 65 and under age 65. There is no drop in outcomes based on tumor location, sex, comorbidities, or socioeconomic status. This reproducibility across real-world populations is reflected in publications like McClure, Farberg, Agha, and Ma, all published in 2024.

Unfortunately, this LCD leans on outdated literature, pre-2020 studies that lack real-time imaging and adaptive protocols. The CMS policy requires a comprehensive and current evidence review. This draft doesn't meet that standard, especially for patients who are frail, elderly, or not surgical candidates. IG-SRT with daily imaging gives them a safe, effective, and non-invasive alternative.

Next slide.

Here's the bottom line. Across 15 peer-reviewed publications, IG-SRT consistently achieves long-term local control rates at or above 99% at two, four, and even six years follow-up. This isn't cherry-picked single-centered data. These are large, multi-centered, real-world studies.

In our largest data sets, including studies I personally authored or reviewed, over 20,000 lesions were tracked with local control of greater than 99%. That's not theoretical. It's real-world evidence at scale.

Next slide.

What do all these studies have in common? They use the Ladd Yu IG-SRT protocol with daily high-resolution dermal ultrasound. This isn't a small upgrade to older SRT systems. This is a distinct technological advancement. It's like going from flip phone to smartphone. Daily imaging is the game changer.

In our studies, 92% of lesions change depth during the treatment, 40% require treatment plan adjustments. Without imaging, these changes would be missed. And you need to do daily imaging, otherwise you don't know when you have to change it. With IG-SRT, we adapt in real time, and that's what drives the superior cure rates.

Next slide.

Let's be clear, IG-SRT without imaging is not IG-SRT. Ultrasound imaging defines tumor margins, monitors response, and allows us to modify treatment dynamically. This capability simply didn't exist in legacy SRT, which is why the cure rates plateaued at about 90 to 95%.

Since 2019, every study using ultrasound guidance has shown superior results. Coincidence? It's causal evidence.

Next slide.

This is one of the most striking omissions. ECRI, the independent evaluator, often cited by CMS, issued a favorable score for IG-SRT, confirming its efficacy and safety, yet the LCD ignores this. If CMS's own evaluators support IG-SRT, that must be part of the policy discussion.

Next slide.

IG-SRT works across basal cell, including aggressive subtypes, squamous cells, including high-risk cases, squamous cell carcinoma in situ, which has even better results. We're seeing a greater than 99% control rate in subtypes with long-term follow-up and real-world complexity. In these studies, IG-SRT has even exceeded surgical outcomes. And contrary to what was presented before, these patients are not lost to follow-up, and I will address this later on.

Next slide.

So this is where the data become overwhelming. Adding dermal ultrasound improves the outcome across all radiation modalities, including traditional SRT, external beam, and older brachytherapy and electronic brachytherapy.

Meta-analyses, logistic regression models, and pooled cohort confirm that IG-SRT is statistically superior to non-image-guided radiation. This is what makes IG-SRT a distinct class, not just radiation, but adaptive intelligent therapy.

Next slide.

IG-SRT is not experimental. It is a first-line treatment for early-stage nonmelanoma skin cancers in patients who can't undergo Mohs surgery, are elderly, frail, or poor physical condition, or have comorbidities or on anticoagulation.

Since 2016, over 120,000 patients have received IG-SRT. It's already becoming the standard of care in many communities and is reimbursed and should continue to be reimbursed properly.

The LCD's reliance on 2020 ASTRO guidelines, which is written before most of these studies, is outdated. This ASTRO also has, we have concerns about ASTRO because of turf battle and coding dilution, their concern. So the policy must reflect the evidence of 2025, not 2020.

Next slide.

Our research team has published extensively in advances in radiation oncology, BMC cancer, dermatopathology, Journal of Cancer Research, and clinical oncology. These are substantial and well-regarded journals with rigorous peer review. All these studies document superior long-term outcomes with the Ladd Yu protocol, driven by daily imaging and real-time adaptation.

Next slide, next slide, please.

Let's look at this case. This is a patient with a high-risk PCC of the micro-nodular type in the nasal ala. And you see the before and after, and this patient does not need to have surgery because the surgery can cause at least a scar, if not a defect or possibly functional problems. So this level of precision gives us non-surgical pathways that rivals and, in some cases, surpasses Mohs surgery. And importantly, we can cover multiple lesions at the same time simultaneously.

Taylor Canova:

One Minute.

Dr. Lio Yu:

Up to three or four lesions, and it just saves on the cost.

Next slide.

Unfortunately, groups like the American College of Mohs Surgery continue to mischaracterize IG-SRT. They circulate comparisons that conflate legacy SRT with failure rates as high as 16% with IG-SRT, which has published failure rates of 1%.

Next slide.

They completely ignored the Kaplan-Meier adjusted peer-reviewed IG-SRT data published in 2020. This is like comparing Tesla to a horse-drawn carriage and saying both are the same because they have wheels.

Next slide.

You may hear clear claims about thousands lost to follow-up. Let me clarify. This critique reveals a fundamental misunderstanding of Kaplan-Meier statistics. Additionally, these are retrospective chart reviews, not prospective trials where patients withdrew, many patients stopped follow because they were cured, not because they dropped out.

Next slide. Let's go on to the end, I want to finish up. Keep going, keep going, keep going, please, keep going. Okay, let's stay here. So, in summary, can you go back?

Yeah.

What was presented before by the ACMS is flat out wrong and ignores the evidence. And this distortion and misinformation and disinformation is very troubling.

IG-SRT is equal or better than Mohs, and it's up to the patient to make the selection. So in closing, IG-SRT is not emerging, it is established. We have a standardized, reducible protocol, multi-institutional data with years of follow-up, independent validation by ECRI as favorable, consistent efficacy across subtypes and patient demographics. Yet, the LCD treats it like an experimental legacy technology that is scientifically indefensible.

It's time for the policy to catch up to the clinical evidence and to do so with input from frontline experts, not outdated assumptions.

Taylor Canova:

Thank you for your comments, but your line -- yes, thank you.

Dr. Luke Barre:

Thank you very much, Dr. Yu. Comments are appreciated. I know the next speaker is Dr. Edward Kim. I wasn't sure if you were on the line. If you're able to raise your hand and speak, the line will be open for you. We'll give you a couple seconds, otherwise we'll move to the next speaker.

Okay. If we do have time at the end, we may come back and check to see if we have Dr. Edward Kim.

If we want to move on to the next yeah, Dr. Ty Hanson, if you're able to speak, the floor should be yours. Your line should be open.

Dr. Ty Hanson:

Thank you very much. Can you hear me okay?

Dr. Luke Barre:

Loud and clear.

Dr. Ty Hanson:

Okay.

Hi. Ty Hanson, DO. I'm in Aberdeen, South Dakota. I'm a board-certified dermatologist. I've been here for 18 years in practice. I'm a clinical professor of dermatology with the University of South Dakota. Also, I'm the regional Dean for the Idaho College of Osteopathic Medicine. I'm also on the board of the South Dakota Medical Association. I'm also a counselor for them.

So I'm presenting today from a dermatology perspective, especially rural dermatology. So I've been here for 18 years. We have no Mohs surgeon here. I've been doing excisions. I see a lot of complex medical dermatology. I see a lot of complex surgical dermatology. And so this has been, IG-SRT has been the most impactful and the most innovative addition to my practice in my 18 years.

I see a lot of rural patients here, obviously, that travel great distances to see me because lack of [inaudible]. So as most of the time is so special in my area, I have to offer patients many options, but we do have some travel issues from the elderly.

We're AG-heavy, so we have people that can't take time off of work for surgical procedures. We lack specialists such as oculoplastics, surgical oncologists. As I mentioned, we don't have a Mohs surgeon here. I'll talk more about that.

So this will become a very important thing that we can offer our patients. So I really appreciate our colleagues presenting, especially Dr. Agarwal and Dr. Yu, I appreciate their comments. And I won't repeat a lot of what they said because of their [inaudible].. I'll try to give you my perspective as a dermatologist.

So next slide, please. Next slide.

So what is IG-SRT? So here's a picture of the machine we use here in Aberdeen, and it's the newest and most technologically advanced form of superficial radiotherapy. And the image guidance, and I agree with my radiation oncology colleagues, allows for adaptive, so its ability to adjust dosage or protocol based on tumor or normal tissue response and anatomy to increase accuracy of treatment delivery. So it's adaptive treatment during the course of care. Field margins and treatment doses are customized to achieve a safe dose distribution.

And so when I'm marking out margins, I can adjust those margins. Typically, we'll use five millimeters, but sometimes we'll use seven millimeters. That allows for critical decisions such as continue with the current plan, changing the plan or discontinuing treatment. And I agree, so if you have a cosmetically sensitive site or a site such as the shin, or you want to give someone more fractions, it allows for those critical decisions.

And so not having that, again, it's like driving a 1980s car and not having air conditioning. And so, we don't use those older technologies anymore. Dermatologists used like Grenz rays back before the advent of most surgeries. So, this is not new to us, but this technology is new. And that's why I believe we need to continue it and continue advancing it, such as integrating artificial intelligence in the future.

Next slide, please.

So what are the benefits of IG-SRT? And I'll probably spend the most time on this slide.

So as my other oncology colleagues commented, 99 plus percent cure rate. So when we talk to patients, we still offer Mohs surgery. I've been sending people to Mohs surgery my whole time in practice. That's a trip to Sioux Falls, South Dakota. That's an over three-hour one-way trip or Fargo, North Dakota. That's the same distance or Bismarck, North Dakota.

They're also now scheduling out months and months. I had a patient with a squamous cell carcinoma that I'm gonna send to Bismarck for Mohs. They can't get them in until September. In the meantime, their cancer is already growing back. So I had to cancel that, or we'll have to find another option for that.

So access to care for us is huge, and access to specialists, a non-invasive treatment option. Patients are really looking for these options. Now, again, we offer Mohs. I do excisions, I do EDNCs. We send people to general surgery here. So, but this is an important option for patients to have.

I've had patients in my treatment chairs crying because they don't want to go for another Mohs treatment. I've had people that drive all the way to Pierre, from Pierre, our state capital, to do IG-SRT because they've had seven Mohs procedures on their face and they just don't want to be cut on anymore. So that's a very important option for us. No limitations of daily activities.

Again, I said, we have a lot of people in AG here and even Medicare patients are still working on their family farms. They don't have time, A, to go down to Sioux Falls during spring planning or fall harvest. Sometimes it's a whole day trip. My Mohs surgeon, she starts at 5.30 in the morning. So to ask an eighty-year-old in January to get on icy roads to get there by 5:30 in the morning, it may be an all-day procedure. She does beautiful work and a great job, but for some of our patients, this is just not practical for them.

Limited downtime. I have, again, people that come in, this treatment does not take long at all. There's no needles, there's no anesthesia, there's no sutures. They go, they get their treatments and they're right back to work, their jobs, their farms, their places of employment, no pain associated treatment of delivery.

Again, people that don't, they have needle phobia, they don't want to be cut on again. No local anesthesia that goes without saying, but I also want to say I have patients with lidocaine allergies. And when I met them, they've said, well, if you're going to use out a lidocaine, I hope you have a crash cart. So I have people, they will drive to just do IG-SRT because they don't want the risk associated with local anesthesia.

Multiple lesion treatments, we can do a lot of our patients here, we're in a very Northern European population here, Scandinavians such as my family heritage, a lot of Germans, so I do multiple, multiple biopsies with multiple, multiple lesions and this offers us multiple treatments.

I also wanted to add as well, IG-SRT, you'll see a picture of the different cones. There's things that in my opinion, there's no other modalities that treat. I've had people with nodular basal cells in the medial canthus, and so that would probably, A, we don't have oculoplastic surgeons here, but that probably cause a lidptosis or a tropion, functional impairment. We have eye shields we can use, and this has caused beautiful, not only cosmetic results, but functional results.

I have another lady that had a huge squamous cell carcinoma on her scalp. We use the 10-centimeter cone. I don't know of any other way that would treat that. So this also allows treatments of lesions that, in my opinion, have other limited options.

And then continuing taking prescription medications. More and more, we see people on not only anticoagulants, but multiple anticoagulants. I even saw an article the other day on managing multiple anticoagulants. I've had people on Plavix, Eliquis, and Aspirin. And so hemorrhaging is a real issue in our area. And so the ability to be able to take those, continue to take those anticoagulants without stopping them is a huge offer that we can give people.

And then the ultrasound guidance provides visual reassurance. Patients want to know, well, how do you know you got this? Or how do you know you're treating the right area? We can show the patients right in the room with the machine, the ultrasound picture, its beautiful color, high resolution, and show patients not only their cancer when we start, but as it's healing and at their six-week recheck, we can see the repopulation of normal tissue.

So I think these are all things that you must take into consideration for patients, for practices like mine that are rural and that don't have a lot of other options.

Next slide, please.

So this is an example, a typical example of an 81-year-old male with nodular basal cell carcinoma. You can see that's on the superior helix. No other treatment history, you know, the health history. And that's why we just got done talking about history of anticoagulant use. So that may be a consideration.

And then you can see the different energies, the total dose there, the treatment course, which is standard for us, seven weeks, three fractions a week with no breaks. So you can see mid-treatment in the middle there. You can see the high-resolution ultrasound. And then you can see the two-week follow-up.

I have, and these are happy patients, and you can see this is preservation of anatomy and also an excellent cosmetic result. We have people with a third of their ears missing, half of their ears missing, I have people with total ears missing. And so this allows us to give people not only a good and very efficacious treatment, but also ability to preserve their anatomy.

Next slide, please.

Taylor Canova:

One minute.

Dr. Ty Hanson:

Next slide.

So you can see the picture in the different cones there. You can see the literature. I'm not gonna, but you can submit that, but you can see those cure rates have been discussed.

Next slide, please.

Again, you can see those cure rates. And I would, again, agree with my radiation oncology colleagues. Again, we don't want to remove Mohs as a method and a treatment, but we also want to keep this option.

I had a guy just today that had a Mohs surgery on his lip that was obviously recurrent. We biopsied that today. He had also had IG-SRT on another lesion on his lip and he was completely satisfied.

So I think we need to keep this as an option for dermatologists such as myself to keep this as an option.

Next slide, please. I'll skip that next slide, please. And next slide.

So this is just a summary of what we're talking about. So I think SRT, IG-SRT should be considered a first line treatment for nonmelanoma skin cancer in appropriately selected patients. Dermatologists should be able to deliver this. It's safe and effective and highly favorable cosmetic outcomes and should be considered a first-line treatment for appropriately selected cases.

Dr. Luke Barre:

Okay. Thank you very much, Dr. Hanson. We really appreciate your feedback and perspectives.

This is going to be the next speaker, Dr. Jonathan Cheng. Dr. Cheng, if you're able to speak, your line should be open, and the floor is yours.

Dr. Jonathan Cheng:

Can you hear me?

Dr. Luke Barre:

We can, but your line is a little bit choppy.

Dr. Jonathan Cheng:

Hello, can you hear me?

Dr. Luke Barre:

Yes, we can hear you. Just that the line is a tiny bit choppy.

Dr. Jonathan Cheng:

Okay, sorry.

Dr. Luke Barre:

Dr. Cheng, did you want us to try your backup, Dr. Burnside? If either Jonathan Cheng or Robert Burnside are able to speak, I think either one, we'll try to open up your line.

I see your hand up, Rob. So we'll try to, you should be able to speak.

Dr. Robert Burnside:

Can you hear me?

Dr. Luke Barre:

We hear you now, yep.

Dr. Robert Burnside:

This is Robert Burnside, and I invite Dr. Cheng to maybe drop out and call back in and interrupt me at any time, but we may have a difficulty with our technical difficulties with Dr. Cheng.

I am Robert Burnside. I am an employee of Elekta Company and therefore I have that conflict. I'm also in contact with other manufacturers of electronic brachytherapy equipment.

So I will go through Dr. Cheng's slides and hopefully he can jump in at any time if he wishes. So first slide, please.

We wanted to talk about what is at stake in this LCD. If this LCD is adopted and coverage is eliminated for electronic brachytherapy, thousands of skin cancer patients will be denied coverage to a viable, safe, and highly effective non-surgical option.

Next slide, please.

So what is the concern with this draft LCD? There was extensive peer-reviewed clinical literature demonstrating safety and efficacy of electronic brachytherapy that was not considered by the authors.

In particular, the reference to this Consensus Guidelines for Radiation Therapy for Skin Cancer, which was published February 2019. That was prior to the publication of long-term clinical data on electronic brachytherapy. This guideline, there were no electronic brachytherapy physician users included in that consensus guideline. The authors of the guideline were conflicted as they were members of the Medical Advisory board of a competitive therapy manufacturer, and they did not include the available electronic brachytherapy clinical data at that time. So over 10 years of safe clinical use of electronic brachytherapy supported by extensive peer-reviewed clinical literature was not considered in that 2019 clinical guidelines. And there are 14 published papers per date, which will all be included in Dr. Cheng's written submission.

Next slide, please.

Clinical rationale for maintaining the coverage of electronic brachytherapy. All of the organizations, NCCN, AAD, and ASTRO, all support SRT as a definitive option. And electronic brachytherapy is a variation of superficial radiation therapy with the ability to deliver hyper fractionated treatment of greater than 400 centigrade.

There's not a distinction in electronic brachytherapy by the machine, it is actually the protocol that is being delivered, and the publications all support this 8 to 10 fraction delivery, which I'll show in a minute. These studies are hyper fractionated. They're more modern, more standardized, and there are no randomized trials of electronic brachytherapy versus SRT, which prove any kind of SRT superiority. Recurrence rates, cosmetic outcomes, and long-term tolerability compare favorably to SRT and even with surgery in certain select cases.

Next slide, please.

So the current code 0394T that covers electronic brachytherapy is going away at the end of 2025. ASTRO, in September 2024 CPT editorial panel meeting, ASTRO created new CPT codes, which are effective January 2026, which bundle electronic brachytherapy into the overall code for SRT, currently called 77X07, and they delete 0394T.

At the May, 2025, AMA CPT Editorial panel meeting, ASTRO opposed creating a new separate CPT code for electronic brachytherapy, advocating for reporting both electronic brachytherapy and SRT under the same code, 77X07, stating that all services reporting to this code are regarded as reasonable and necessary according to the policy criteria.

So, this acknowledges that both electronic brachytherapy and SRT utilize similar photon energies and treat the same anatomic conditions.

Next slide, please.

So, again, although electronic brachytherapy and SRT are very similar to each other, there are differences in the way that they are delivered. On the left, we see that electronic brachytherapy, it's delivered in typically only eight to 10 treatments, and then superficial radiation therapy is over 20 treatments.

On the electronic brachytherapy side, a AART certified radiation therapist always is involved and remains in the room, which is not true for SRT. The electronic brachytherapy is always supported by a board-certified radiation oncologist and a medical physicist ensuring the highest quality of care delivery, because the high dose rate of fractionation typically at higher than 400 centigrade per fraction is necessary.

Finally, state regulations require radiation oncologists to be involved with the treatment process of electronic brachytherapy, which is not true for SRT.

Next slide, please.

Our ask, we respectfully request that the section describing the elimination of coverage for EBT be deleted from the draft LCD policy because ionizing radiation as produced by electronic brachytherapy is proven to cure skin cancer.

Electronic brachytherapy has been proven safe and highly effective with minimal side effects and excellent cosmesis, according to multiple publications, and certain skin cancer patients can benefit from a viable non-surgical treatment option.

Next slide, please.

Again, this is the bibliography that will be, publications that will be provided, including some that were not included in the LCD.

I want to take a moment to go beyond what Dr. Cheng's prepared slides to just comment that other manufacturers of the equipment that is used for electronic brachytherapy have reached out to the practitioners using this technology and they would like to make sure that everyone realizes that there are no statements from any of the medical organizations that can be interpreted as banning electronic brachytherapy.

The claims of SRT being superior to electronic brachytherapy contained in the LCD are not valid. There are no head-to-head randomized trials that compare electronic brachytherapy and SRT, and that electronic brachytherapy benefits from more precise dose delivery, standardized geometries, and simpler shielding logistics, which improves access and compliance to the technology.

So, there is robust and growing literature supporting the clinical benefits, safety, and durability of electronic brachytherapy, particularly in non-surgical candidates.

Thanks for your time.

Dr. Luke Barre:

Thank you, Mr. Burnside. I do want to thank all of those who spoke for their time and thoughtful insights.

That concludes the section of this meeting that was dedicated to SRT. And so with that, I will hand it off to Dr. Rajadhyaksha.

Dr. Aparna Rajadhyaksha:

Thank you, Dr. Barre. And thank you, everybody, for attending this meeting on Lab: Special Stains. And thank you for your patience, as this is the last policy on this Open Meeting.

Next slide, please.

Okay, so one of the things I wanted to talk about is why did we decide to go through this policy and I guess reconsider and update it.

We, you know, we got a request for reconsideration some time ago since the other MACs had updated their policies and we were asked to reconsider ours in line with the other MACs, which we did.

So, and to update it to make sure we've included certain special stains, which were not included before.

So, what this policy basically is, it's not to tell people what to use special stains for and where you should be using it, on what cancers you should be using it. It's not supposed to be all-inclusive and it basically, it's giving you or it's talking about the medically necessary criteria for the use of these special stains.

Next slide, please.

Okay. So, you know, a lot of claims reviews done, various scenarios looked at before coming up with this policy, which is thoughtful. And a few of the aims of this policy really was when reflex stains should not be ordered before looking at the slide, the role of the pathologist would be to look at the slide and then decide what kind of stains needed to be ordered.

Use of the special stains and without clinical evidence that the stain is actionable or provides a treating physician with information that changes the management would be, is needed. And use of added stains when the diagnosis already known, you know, what do you really needed for? What extra information are you getting from there is needed.

Next slide please.

So I talked about medical necessity, and this is what really this policy aims to do.

The pathologist may perform such additional stains with certain criteria. Services are medically necessary so that there's a complete and accurate diagnosis can be reported to the physicians who are managing the patient.

Results of the tests are communicated and used by the managing physicians. Pathologists document there in the report what the additional testing was. And basically, the above citation means that reflex templates of pre-orders, stains to review is not reasonable and necessary.

They should, again, as I said before or mentioned before, it should really be done after the slide has been looked at.

Next slide, please.

There are exceptions that occur, and we recognize that.

And, you know, these exceptions are based on time, they included on certain time sensitivity, included on certain tissue, infectious disease, immunocompromised patient, and that's understood.

So all that's really needed is document why it was done and how the stains would affect management. So it's really simple. It's just to have some guidelines there as far as how to utilize these stains, you know, and when to use them thoughtfully and to document the results in the report.

That's really it. And from my end, and I will open it up to questions.

I believe this first speaker was Dr. Dylan Miller. I am not sure if he's here. Dr. Dylan Miller? All right. Let's go to the next speaker and then maybe see if we can come back.

Dr. Eric Loo.

Dr. Eric Loo:

Hello. Can you hear me?

Dr. Aparna Rajadhyaksha:

Yes, I can.

Dr. Eric Loo:

Oh, great. Thank you. My name is Eric Loo.

I am a pathologist that is providing commentary on behalf of the California Society of Pathologists. I'm currently staffed at Quest Diagnostics. I used to work at Dartmouth Health in New Hampshire and was on the CAC there, and I'm very grateful for that opportunity to participate in the discussions here.

Now, the California Society of Pathologists reviewed the draft LCD language, along with a lot of generous assistance from the College of American Pathologists, which is our national professional society, and you know, we've generally been eagerly awaiting and are very supportive of the language in this draft proposal.

In general, we do see it as a much-needed update to the current language that is being used. That said, there is one wording change that we know has been suggested by the California Clinical Lab Association, which we agree with and would also support.

So under the special stains IHC medical necessity section of the draft LCD PDF on page three. underneath bullet point two, under the statement that says the pathologist may perform additional tests under the following circumstances, it currently reads, results of the tests are communicated to and are used by the treating physician slash practitioner in the management beneficiary.

We do suggest, along with the California Clinical Lab Association, that we strike the and are and change that to may be used. So the results of the tests are communicated to and may be used by the treating physician in the management of the beneficiary.

As it's currently worded, the finding suggests that it would be a requirement for the laboratory to determine that the ordering physician uses the IHC results in treating the patient post final pathology report release. And in reality, laboratories cannot control or verify whether the treating physicians use those stains in downstream clinical decision-making or not.

We have noted that the CCLA has observed that some Medicare Advantage plans interpret the current language very strictly resulting in inappropriate denials during audits, despite clinical justification at the time of service. And so, you know, changing the wording from are used to may be used would better align with broader Medicare principles that focus on intent and documentation at the time of ordering and not on the retrospective clinical use.

But other than that, we're supportive of the draft LCD.

And I want to thank you for the opportunity to share my thoughts with you all in this forum, your consideration and all the work that you've done to update the LCD, and I hope you all have a nice summer.

Dr. Aparna Rajadhyaksha:

Thank you, Dr. Loo. I hope you will give your comments in writing so we can consider those. Thank you.

Taylor Canova:

Okay I'm not seeing the other two that haven't spoken yet on. Do we want a chance to have them speak maybe or raise your hand if you're an unidentified caller before we move closing, either Dylan Miller or Edward Kim?

Okay, in closing we would like to communicate the next steps in the policy development process.

The comment period for Transurethral Waterjet Ablation of the Prostate will remain open until July 12^th, 2025, and the comment period for Superficial Radiation Therapy for the Treatment of Nonmelanoma Skin Cancers and Lab: Special Histochemical Stains and Immunohistochemical Stains will remain open until June 28^th, 2025.

All comments to be considered by our medical directors for the proposed LCD must be submitted in writing. Written comments can be mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCD is located on our website at noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCD. Responses to comments will be viewable in the response to comments article.

Please monitor our website or register for listserv notifications to informed of actions taken on our proposed LCDs. And medical directors, do you have anything else that you would like to say before we end the meeting? I apologize, Dr. Rajadhyaksha, if I had cut you off before.

Dr. Aparna Rajadhyaksha:

No that was it. I just asked for the comments to be sent to us in writing, essentially what you said. Thank you.

Taylor Canova:

Okay great. If no other comments from the other medical directors, that will conclude our meeting. Thank you.