Multiple LCDs: MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia; MolDX: 4Kscore® Assay; Nerve Blockade for the Treatment of Chronic Pain and Neuropathy; and Lumbar Epidural Injections - Open Public Meeting - May 26, 2022

Last Updated Jun 30 , 2022

Multiple LCDs: MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia; MolDX: 4Kscore® Assay; Nerve Blockade for the Treatment of Chronic Pain and Neuropathy; and Lumbar Epidural Injections - Open Public Meeting Transcript - May 26, 2022

Jocelyn Fernandez:
Hello, everyone. Before we begin the meeting, I would like to make the following announcements. This meeting will be recorded. The audio recording and written transcript will be posted to our website following today's meeting.

All lines are currently being muted and will remain muted throughout the meeting. Only registered commenters will be allowed to present today.

For the commenters, 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 we will hear the moderator’s voice when one minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments.

Please be mindful of sharing any personal health information during your presentation.

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. Oakes. Dr. Oakes you may begin.

Dr. Oakes:
Thank you, Jocelyn, for that nice introduction.

We will begin today with public comments on the MolDx Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia.

Will our first speaker, please come forward.

Dr. Moynihan:

Dr. Oakes, the speakers may not be ready because we reordered the presentations. So actually we're starting with Nerve Blockade for Treatment of Chronic Pain and Neuropathy.

Dr. Oakes:
OK, well, the agenda was not updated on the SharePoint, so Dr. Moynihan [inaudible].

Dr. Moynihan:
Sorry to scoop you there. Hi everybody.

Nerve Blockade for Treatment of Chronic Pain and Neuropathy is being retired in one section. The initial section of this LCD deals with cervical, epidural injection. So, this portion of the LCD is being removed and the rest of the LCD that deals with the treatment of chronic pain and neuropathy will stand as is.

To date, no one has registered to make any comments, but we would like you to know that this is being retired in the section that deals with cervical, epidural because cervical epidural has been incorporated into another LCD that has gone through the entire LCD process and is already active. So, that is why this section involving cervical epidural is being removed from this LCD and that portion of the LCD is being retired with the rest of it standing with regard to chronic pain and neuropathy. Thanks.

All right. So Lumbar Epidural, Injections is another policy that because of the LCD that that deals with every sort of epidural is now published and has gone through the LCD process.

The previous LCD on lumbar epidural injections became superfluous and we are now therefore retiring that because we have another more updated LCD that involves all areas of epidural injection.

There haven't been any requests for anyone to speak to this issue and this is being retired.

OK, Dr. Oakes, I'm done.

Jocelyn Fernandez:
Dr. Oakes, it's the 4KScore Assay Testing.

Dr. Oakes:
Thank you. That helps.

The next LCD then, is the MolDx: 4KScore Assay Testing. As with the previous LCD, this one is being retired at it is no longer cognizant to the process and our understanding is the test, is no longer available, so therefore, this is solely a notice of retirement, in case anyone would wish to present comments in writing to us.

Next slide, please.

OK, now we can start where I left off earlier: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia. This policy does have some comments to be made, so the first commenter is Dr. Aklog.

Dr. Aklog, are you able to…

Dr. Aklog:
Can you hear me, OK?

Dr. Oakes:
Oh, we can, Thank you. Please go ahead.

Dr. Aklog:
OK, excellent. I had some slides on my, OK there we go. Great, excellent. So, I can just ask them to be advanced along the ways will that work?

Jocelyn Fernandez:
Yes. Please.

Dr. Aklog:
Perfectly OK. Great. So let me dive right in. For the second time I'm Dr. Lishan Asklog. I'm the chairman and CEO of Lucid Diagnostics. I also happen to be a board-certified thoracic surgeon. And I'd like to thank the Noridian team here for the opportunity to present our comments on this important proposed LCD.

I'd like to start by reminding us why we're here today, and that is the devastating toll.

Next slide, please.

The devastating toll of Esophageal Adenocarcinoma that's afflicted in the US. You can see some important data here. I'll just highlight a few things, which is the 80%, five-year mortality. It's our second most lethal cancer, and there's been a 500% increase over the last four decades, And most importantly, death rates have gone up in contrast to other common cancers, and we believe, in most, would agree, as a result of the fact that other cancers have successful early detection programs and esophageal cancer does not. Based on epidemiologic data it's estimated that over 60% of these deaths of the 16,000 here are Medicare beneficiaries.

Next slide, please.

Obviously, there's been a recent push by the administration, as part of the Cancer Moonshot to end cancers as we know it, and one of the opportunities is to decrease cancer deaths. And we believe that one of the greatest opportunities in terms of preventable cancer deaths are actually an esophageal cancer deaths, and I hopefully will be able to explain that to you.

Next slide.
We know that esophageal cancer deaths can be prevented. The progression from Gastroesophageal Reflux Disease to Barrett's Esophagus, which is, the known as esophageal pre-cancer to an Esophageal Adenocarcinoma can be halted with endoscopic surveillance and ablation of dysplastic Barrett's Esophagus. We have all the elements necessary to do an early detection program except for a widespread screening tool. It's important to note that for this cancer, you actually have to pick this up at the pre-cancer stage because even stage one Esophageal Adenocarcinoma has a 40% five-year mortality.

Next slide, please.

And for over a decade, through at least three rounds of clinical practice guidelines, guidelines have recommended that esophageal pre-cancer detection occur in at risk patients with Gastroesophageal Reflux Disease to prevent cancer deaths. The risk factors are well established, they've been reiterated in the most recent update from the American College of Gastroenterology, and the prevalence in this group is meaningful. It's about five to 15%.

Next slide.

We also know that in esophageal, despite the strong consensus on testing to detect pre-cancer that in Esophageal Adenocarcinoma diagnosis is nearly always a tragic missed opportunity. Less than 10% of people who are recommended for an endoscopic detection undergo endoscopy.

And therefore, it is nearly always a death sentence. It always comes as a complete shock and the patient with longstanding GERD.

At its most importantly, as I related terms of the moonshot goals, likely death can nearly always have been prevented if an at-risk patient had been appropriately screen, monitored, and undergone a curative ablation of their dysplastic Barrett's Esophagus. So increasing the guideline compliance from 10 to 50% could have a significant, significant impact on cancer mortality.

Next slide.

So non-endoscopic biomarker test biomarker testing is the missing element to prevent those Esophageal Adenocarcinoma deaths through early detection. And the most and the latest, recently published guidelines from the American College of Gastroenterology should note that were published after the publication of the proposed LCD, do in fact, recommend non-endoscopic capsule device testing combined with a biomarker as an acceptable alternative to endoscopy for detecting esophageal pre-cancer work, also known as Barrett’s Esophagus

Next slide.

So, the only commercially available tests that can detect this is the EsoGuard Esophageal DNA Test. It's a bisulfite converted NGS, met DNA methylation assay. It performs a test on cells collected in a very brief office procedure that doesn't require anesthesia. It takes a couple of minutes. And it assesses methylation at 31 CPG sites that's commercially available in the US as a laboratory developed tests performed at our laboratory CLIA certified laboratory in California.

Next slide.

We have proceeded to take EsoGuard and its PLA code through the CMS Payment and Coverage process. Payment was published and effective through the CLFS process in January of 2021. And we've we submitted in May of 2020 technical documents in support of the proposed LCD that was just recently published. We've submitted written comments after CAC meeting. We've also submitted written comments, as have many, many others to MolDx directly and participated in their open meeting.

Next slide.

So, we have some topics, and these are outlined in much more significantly detail in our written comments. But I'll try to give an overview of them. These are suggested modifications to the proposed LCD. They focus on the coverage indications, the ideal performance criteria, the updated ACG practice guidelines, as well as some notion around clinical utility of endoscopic and non-endoscopic detection.

Next slide.

So, we do have some suggestions, and, as I mentioned, there'll be covered in more detail on our written comments around the coverage indications. There is language in the in the proposed LCD that I highlight on the slide. I won't read it. That we believe can be improved by, would better reflect the current status tests in this space. And the intent of these proposed suggested modifications is to allow the submission and implementation of a technical assessment to secure future coverage without the prolonged effort to update the LCD. And these suggested modifications are consistent with other published LCDs in the past and we will highlight that in a little bit more detail on our written comments.

In addition to this, we do believe that the coverage indications could use some clarification with regard to language as they try to simultaneously address two very specific, to two different categories of tests, so, we think they can more clearly delineated these two conditions.

One is testing in GERD patients to identify conditions along the spectrum from Barrett’s to esophageal cancer. And the second very distinctly is testing in patients with no non-dysplastic Barrett’s to detect progression to Dysplastic Barrett’s in esophageal cancer. And, again, we'll address these in a little bit more detail.

Next slide, please.

We do have significant concerns about language that's not in the criteria, but it's in the later in the document that refer to an ideal performance criteria of over 95% for sensitivity specificity. Again, we have more detailed arguments to present on this, but to summarize, we think that ideal criteria obviously should exist, and they, and they balance risk of benefits. But these criteria did not incorporate very important things that are relevant in assessing the risks and benefits of a test in this condition, the prevalence, as well as current practice and a focus on the negative predictive value, positive predictive value, as opposed to sensitivity specificity. This, this bar, I said today, really elevates the bar higher than any known tests that we're aware of. It exposes the patients to the possibility of not having access to a useful test that can be that can have an impact clinically.

Next slide.

And we outline here, and we'll outline further in the, in the written commentary, that I'll highlight here, that the EsoGuard test has a negative predictive value that's estimated around 99%, which is well above, at or above existing test. And the positive predictive value of the 50, 50, 35 to 65% range is also similar to other tests, and similar cancer detection tests. Reminder that over 90% of patients indicated for pre-cancer testing do not currently undergo testing, and a risk of a false negative test should be assessed in the context.

Next slide, please.

We provide specific recommendations to propose modifications to include the newly published guidelines from the American College of Gastroenterology, which recommend and suggest swallowable, not endoscopic capsule devices combined with biomarkers as an alternative to endoscopy for this process.

Next slide.

We also just have a few comments, and again, we'll elaborate in our written comments around clinical utility. We actually would argue that the that the clinical utility of endoscopy for early detection, and now non endoscopic biomarker testing is established. We have established risk factors and recommendations based on the clinical data.

Next slide, please.

These tests in this category, including our test EsoGuard should really be seen as a triage test that is identifying patients who should undergo endoscopy. Where the remainder of the algorithm, as outlined here, from the clinical guidelines, can be assessed in positive patients.

With that, I will close and appreciate the opportunity to make some comments, and we look forward to submitting our more detailed written comments along the same lines. So, thank you very much.

Dr. Oakes:
Thank you, Dr. Aklog. Appreciate that presentation.

Take just a minute here to get our slide deck switched over.

Next speaker for today will be Mindy Mintz Mordecai, President, CEO of Esophageal Cancer Action Network Incorporated. Ms. Mordecai are you ready to speak, please?

Mindy Mintz Mordecai:
I definitely am. I want to thank Noridian for the opportunity to provide comment on the Local Coverage Determination regarding the Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia.

Please advance twice.

My comments come from a somewhat different perspective on why this decision matters so much. 15 years ago, my husband, excuse me.

It doesn't always happen, but now I'm crying. 15 years ago my husband Monte Mordecai was diagnosed with Stage 3 Esophageal Adenocarcinoma. Our children at the time were just 8 and 11.

Please advanced twice.

Monte maintained a very positive attitude throughout his rather brutal treatment.

Please advance.

He was treated with two chemotherapy agents, one targeted therapy, and radiation treatments. His radiation oncology nurse told us that the treatment he received brought Navy Seals to their knees.

Please. Advance.

Once he recovered a bit, Monte underwent an esophagectomy, which required the removal of his entire esophagus and the repositioning of his stomach to attach it to what was left of the top of his esophagus. What he was left with, something we jokingly called [inaudible] but it is no joke because patients who undergo esophagectomy no longer have a sphincter to separate there, now vertical stomach, and they can never lie down without risking aspiration.

So, even if you're one of the lucky few who survive esophageal cancer, your life will forever be altered very dramatically. We've seen even long-term survivors' die of this aspiration, pneumonia.

Please advance.

But like most patients with the esophageal cancer, my husband's cancer came back.

It reared its ugly head less than two months after his surgery. He had a six-centimeter tumor in his liver and he began treatment with two of the targeted therapies at the time were believed to have some impact on his cancer.

Please advance.

But after treatment, the tumor in his liver had doubled in size, and we had to call in hospice care.

Please advance.

On March 27th, 2008, less than one year after his diagnosis, we lost my 63 year old husband to esophageal cancer.

Please, advance, twice.

Our story is typical of families affected by esophageal cancer. Only one in five will survive five years.

Advance.

Patients who are diagnosed with the metastasis are given very little hope. Only 5% will survive five years. Patients, like my husband who have regional disease get better odds, but still only about one in four will survive at that amount of time.

Advance.

But, if esophageal, cancer is caught at earlier stages, almost half can hope to live that long. That's much better, but it's still pretty terrible odds. Barrett's Esophagus is the only known precursor of esophageal adenocarcinoma, and when it is detected, patients can undergo outpatient treatment and nearly all who do will never develop this devastating cancer. That is why this decision is so important.

Early detection, especially detection of Barrett's Esophagus, is the only real hope for patients at risk for this devastating cancer.

Please, advance twice.

We know that early detection saves lives.

Advance.

But most patients with esophageal cancer are diagnosed at late stages. About two thirds are diagnosed with advanced disease when treatment is really rarely avail, effective.

Please, advance, twice.

This terrible situation is the reason why I worked very hard to establish the Esophageal Cancer Action Network (ECAN) 13 years ago. Our mission is to save the lives of those at risk for esophageal cancer. We do it by making the public aware that acid reflux can cause cancer and promoting early detection and supporting medical research funding and innovation. Our primary goal was to make sure that the public knows the risks.

Advance.

Advance

Can people hear that?

Dr. Oakes:
No, we cannot.

Mindy Mintz Mordecai:
I was told that the audio would work from my PowerPoint. I'm sorry.

Jocelyn Fernandez:
I apologize. Ms. Mordechai, we tested it yesterday, and it worked. But I apologize for that.

Mindy Mintz Mordecai:
So can we just stop for a moment and I'll just tell you that what you saw there but could not hear, were are my children. And what they were saying is that, when daddy got sick, we didn't know that heart burn could cause cancer. When daddy got sick, we didn't know esophageal cancer was one of the deadliest diseases there is and at the end, my youngest child says, when daddy got sick, we didn't know how much we were going to miss him when he was gone. And that is the fact. And my family is just one of thousands that have gone through this terrible devastating impact because very often it is, you know, three times more likely to happen in men. So, children are losing their fathers all over this country because of this devastating disease.

Advance twice, please.

But raising awareness doesn't really matter if the call to action leads nowhere. It's unacceptable that the only way a patient can get checked for this devastating disease is via an expensive sedated procedure that's not without risk and is impractical to provide for everyone who is at risk for esophageal cancer.

Advance twice.

We at ECAN and all of those in our patient and advocate community have been anxiously waiting for these minimally invasive detection tests that can identify those patients at risk for esophageal cancer at a point where it can make an important difference. That is why this decision is so critical to us. We beg you to provide coverage of these early detection tests because the existence of tests that our patients can't access is really meaningless. It deprives our community of the incredible scientific advances that have made such a difference in so many other disease states.

Advance.

Advance.

Every 36 minutes, one American will die of esophageal cancer. And what it means, if we had these early detection devices, is that we could save many more of the lives of the 16,000 who currently die every year of esophageal cancer in the United States.

Advance.

Advance.

I hope you can understand why we believe so strongly that esophageal cancer patients cannot wait.

We hope that you will provide coverage for these important tests. And we have the esophageal Cancer Action Network, are grateful for the opportunity to share the testimony.

Dr. Oakes:
This is Dr. Oakes again. We'd like to thank both for our speakers for very clear presentations today. This concludes the presentation portion of today's meeting. We will now move on to closing and next steps, Jocelyn.

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

The comment period for the proposed LCDs will remain open until June 11, 2022, for Nerve Blockade for Treatment of Chronic Pain and Neuropathy; MolDx: 4Kscore Assay, and MolDx: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia.

The comment period for Lumbar Epidural Injections will end on June 18, 2022. All comments to be considered by our medical directors for the proposed LCDs must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCDs. Responses to comments will be viewable on the Response to Comments article.

Please monitor our website or register for list serv notifications to be informed of actions taken on our proposed LCDs.

I will now turn this meeting back to Dr. Oakes for final remarks.

Dr. Oakes:
Thank you, Jocelyn. And with that, for today, we want to thank all those who participated by phone, which is the only way today, or by computer.

Thank you so much for taking time out of your day.

We do look forward to getting your comments.

They are always helpful to help drive for the best policy possible.

And with no further ado, we'll bring this meeting to a close. And, again, have a great afternoon!

 

Last Updated Jun 30 , 2022