Multiple LCDs: Non-Invasive Fractional Flow Reserve (FFR) For Ischemic Heart Disease; MolDX: Plasma-Based Genomic Profiling In Solid Tumors; Epidural Steroid Injections For Pain Management Open Public Meeting - February 24, 2022 - JE Part A

Jocelyn Fernandez:
It’s already two minutes past the hour. Dr. Oakes, would you like to begin the meeting?

Dr. Oakes:
Love to. We do have some of our speakers here and we may need to juggle things a little bit. So, welcome everyone to our open meeting for the following LCDs.

We have Proposed LCD Non-Invasive Fractional Flow Reserve for Ischemic Heart Disease.

Number two is Proposed LCD MolDX: Plasma-Based Genomic Profiling of Solid Tumors.

And then last we have Proposed LCD Epidural Steroid Injections for Pain Management.

So we look forward to hearing some good discussion and with that I will turn the Non-Invasive Fractional Flow Reserve discussion over to Dr. Larry Clark.

Dr. Clark:
Thank you, Gary. Yes, we’re here to talk about DL38613 and DL38615 by the name that’s on your screen.

And this has been an interesting and successful collaborative effort regarding a useful cardiovascular technology.

In the time, since the last issue into our effort, there has been a major multi-society paper that has come out, some discussion of some expanded indications. We have two speakers today. And, Jocelyn, I believe Dr. Rogers is, oh Dr. Bies is first, my apologies. Dr. Bies, Dignity Health. Thank you.

Dr. Oakes:
May I interrupt just a second, Larry. Just one part. I just need to make sure everyone knows that this meeting is being recorded.

There will be an audio recording and written transcript posted on our website following today’s meeting, so thanks to each of you. I apologize for that irregularity.

Jocelyn Fernandez:
Thank you, Dr. Oakes. I don't see that Dr. Bies has called in. But Dr. Bies, if you are on the call, can you please use the raised hand function, so that we can identify you and unmute your line?

Let’s give it a couple seconds.

OK. Dr. Bies is not on the call. Let's move on to the next commenter.

Dr. Clark:
And that would be Dr. Rogers. And please introduce yourself, sir.

Dr. Rogers:
Yes. Are you able to hear me now?

Dr. Clark:
Yes sir. Please go ahead.

Dr. Rogers:
Great. So this is Campbell Rogers. I'm the Chief Medical Officer at Heartflow. I have a conflict of interest to declare which is that fact that I am a full-time employee of Heartflow.

I also would comment that stipulate that all of the comments we'll make here will, of course, be submitted in writing as part of the open comment period.

Can you go forward, do you have the slides teed up?

Jocelyn Fernandez:
Yes. Hold on.

Dr. Rogers:
Great. Thank you.

The first thing I would point out is that we're very grateful for this opportunity to provide input into what we see as a really important and thorough new draft revision of the current LCD. It was clearly well thought out. It reflects the recent ACC and AHA guidelines as was mentioned at the beginning. We certainly applaud the work that went into this. Again, we see it as very thorough.

There are a few points that I would like to highlight, and I will hear that we would suggest potentially revisiting. But as you'll see, they're relatively sort of specific. And certainly the broadening we, we applaud and I think completely appropriate, the broadening of the window for stenosis severity, which is a really big change to be in accordance with the guidelines. So, so, if you go to the next slide after this, please. And the next slide after this, I want to highlight a couple of points from the guidelines.

The first is that the guidelines from the ACC and the AHA relate to chest pain. They divide the chest pain into four types or sections. Stable or acute and patients with suspected or with known coronary disease, known coronary disease being defined as prior stent, prior bypass operation, prior heart attack, myocardial infarction. In all of those, the heart flow, FFRCT is recognized with a class of recommendation to A and coronary CTA is recognized with the class of recommendation, one level of evidence A for patients with suspected coronary disease, both stable and acute. Go to the next slide, please.

The purpose that comes through, the rationale behind the class of recommendation that comes through in the guidelines is summarized here. The text at the top is directly from the guidelines, the highlighting is mine. That is a coronary stenosis, from 40 to 90% on CTA. Leading to FFRCT, and the general clinical value proposition is avoiding false negatives, avoiding false positives, and increasing clinical clarity. And those are the points that come through in the guidelines. Next slide, please.

So, onto the indications in the draft LCD which is currently out there. I put them here and you'll see, I'm going to go forward to the next slide in a second and I've highlighted a couple of these in red to be specific topics. So you can go forward, please.

The first specific topic is that the current indications talk only about acute chest pain and no known coronary disease. And they also in a different place talk about acute chest pain with coronary stenosis of 40 to 90%. If you go below that first horizontal line, given the guidelines and the language I just showed in the previous slides, we would suggest revision to also include stable chest pain, not just acute, to be consistent with the guidelines. Of note, in the LCD, the stable patients are referenced in the coverage guidance section, so, I think this, perhaps, it's just a little bit of a disconnect between sections of the guidelines. In the box at the bottom, our proposed revised wording would be something like intermediate risk with stable or acute chest pain, and with known coronary stenosis from 40 to 90% on CTA which would embrace all of those and would be consistent with the guidelines which you see again cut and pasted at the bottom. You go to the next slide, please.

The only other place in the indications we wanted to point out again, it's a subtle wording change, and it is as follows:

There is reference made to not performing stress testing and FFRCT in conjunction with one another and the rationale for that is understood, of course. The quibble that we have is that there is a clause, as you see in red here, unless the FFRCT was not of high quality and an alternative study needed. What you see at the bottom is, we would propose a revision to that to say unless the CTA was not of adequate quality. And the reason for that is, of course, the clinical sequences a CTA is done and sent, submitted for FFRCT, if it is not of sufficient image quality. You can go back one slide, please. If it is not of sufficient image quality, then the cases were turned, there's no charge for it, there's no processing of FFRCT. So we would propose that the image quality which comes into play is that of the CT. It's not that the FFRCT itself is of higher or lower quality. You can go to the next slide, please.

And this does show the coverage guidance support paragraph, as mentioned earlier, with the stable coronary symptoms being highlighted, again, for that disconnect between stable and acute.

And we wanted to talk a little bit about the higher grades that in prior LCDs, there's been a lot of back and forth about whether a patient who has one stenosis over 90% and also has other stenosis that are less than 90% is indicated for FFRCT and in discussions with the MACs, the message back to us from medical directors has been, yes, that is included. That is indicated if somebody has a stenosis less than 90%, even if they have one more than 90%. So, we wanted to suggest this be clarified in the new draft LCD. The proposal for that is what is listed as number two at the bottom. To revise it to if higher grades stenosis is greater than 90 are present and no other stenosis 40 to 90 are identified, the study is not medically necessary.

Finally, there is appearance in this coverage guidance paragraph of less than 30%, you see in red. For internal consistency, we would suggest that be revised to less than 40% for consistency with that 40 to 90% rate. And then, finally, the last sentence of the coverage guidance paragraph excerpted at the top. If extensive plaque is present, high-quality CTA is unlikely and stress testing preferred. Point number four at the bottom is, we would suggest removing this, and we will submit publications to support this in our written comments. High plaque volume does not, in and of itself, impair CTA quality and there are published clinical studies now using CTA and FFRCT in patients with very high plaque volumes and multi-vessel coronary disease. You can go to the next slide, please.

In terms of restrictions, there are a few we want to highlight, we'll talk a little bit about the first three in red, numbers 1, 5 and 8. This dispense here at number 11 talks about the stenosis less than 50%. The restriction, again, we would suggest revision to less than 40% for consistency within the LCD. If you go to the next slide, please. Go to the next slide beyond that, please. We've talked about this. Great.

For the others having to do with stents and pacemakers and heart valves, they all relate to image CTA, image quality, and the artifacts which can be induced by those indwelling cardiac devices. I would highlight that the process in CT scan is submitted for FFRCT is that the image quality is assessed before FFRCT is performed. And if it is found to, the images are found not to be of sufficient quality because of artifact, for example, from a pacemaker lead or a heart valve, the case is returned, and no processing is undertaken, no charges levied. And we go back then to the site and say, "here are the reasons why this chart in this case was returned." However, there are patients who have pacemaker leads or heart valves where it is possible to process the artifact does not in fact impair visualization of the coronaries and there's no inherent reason that a pacemaker lead or a heart valve, artificial heart valve should impair the accuracy of the FFRCT component, if, in fact, the artifact is not in the way of the cornea. So, our suggestion, if you go to the next slide, please. And go one beyond this, please.

Our suggestion is to revise, to remove those restrictions and simply leave it to the FFRCT Quality Inspection to decide if cases, for example with heart valves or pacemakers, are in fact it acceptable and processable.

Final point, and this is my last slide, relates to inter-coronary metallic stents. There is, you go back one please. For inter-coronary metallic stents, our instructions for use, which are on this slide and will be submitted of course in our written comments, have specific circumstances where we are and are not able to process cases with metallic stents. The suggested revision for this restriction will be what's written at the bottom left of this slide, which corresponds exactly to the IFU in our FDA cleared indications. So those would be a metallic stent is a restriction if it's present in the left main, if the left main has a stenosis, and there are multiple stents, or if there are multiple systems with metallic stents, those are restricted, we do not process those. But patients who may have a single stent in one vessel and disease in other vessels for which the physician is interested in this analysis are within our instructions for use.

So, let me stop there. We appreciate the time. We certainly appreciate all the work that's gone into this new draft LCD. And we will be submitting all of these comments of course in writing. Thank you.

Dr. Clark:
Are there any questions? I'd like to just ask an anatomic question. Is the left main intra-coronary stent more obstructive in terms of it's artifact? I mean that is a point that has been reinforced and come up over and over, why that unique anatomic location?

Dr. Rogers:
Yeah, so that's a great question, Dr. Clark, it's not that. It’s that, the way that we handled coronary stents in our processing is to make certain assumptions about them and how they redirect flow.

Those assumptions are, changes in flow in one specific vessel have very little effect on other vessels, so we're able to sort of, I'm over-simplifying and I apologize. We're able to sort of ignore the possible effect of a stent in one vessel on other vessels, unless it's so far upstream, as, for example, it can be in the left main. So, it's not it's not the artifact. No, it's the more of the physiology that it imposes.

Dr. Clark:
Makes sense. Thank you very much. Jocelyn, has Dr. Bies arrived or will we be moving on to Dr. Rabbat?

Jocelyn Fernandez:
I believe Dr. Bies has called in, let me just double check.

Yes, he has called. Let me unmute his line.

Dr. Clark:
All right, thank you. And thank you for your patience Dr. Rabbat.

Dr. Bies
Yeah, I hear Dr. Bies here, thank you for taking the time to have me call in today, I'm Roger Bies. I’m historically an interventional cardiologist but have been a proponent advocate of cardiac CTA, and we've had an active program here in Arizona for 15 years. We have an international training course that we teach out here. We've had people from all over the world come here and train. And we have been using CT and CTFFR to evaluate our patients. We have one of the few programs that has 24/7 availability in an emergency room to rule out unnecessary hospitalizations, and I personally read about a thousand cardiac CTA’s a year. I also act as a Chief Medical Officer for a couple of Dignity Hospitals here in Arizona and help steward our program here for our patients.

And I liked the presentation that was just performed here. I am in agreement with most of the things that have been said. I would say from a standpoint of the potential artifacts of pacemakers, valves, stents and other vessels, I agree that it's really a majority of the time the vessels are very well read in those instances, and you really don't have a lot of artifacts that's influencing your ability to read the vessel's from a pure cardiac CT angiogram standpoint. And if the artifact doesn't affect the basic read, it would also likely have no impact on a CTFFR measurement.

And with CTFFR, we do you see a lot of value in that, especially with asking for the expanded dose, expanded percent range stenosis, as you know, anatomy and physiology don't always match up very well, and we found that the FFRCT helps us on both ends of the spectrum.

As you know, for people that have stenosis, even in that 30 to 50% range, there is that range from 19 to 44% of them, the LED being the highest one, where you can still have a physiologically significance stenosis and something that doesn't appear to be that bad anatomically in them. For today's conversation, on the other end of the range, when you have a severe stenosis in the 70 to 90% range, where you're thinking immediately, at least anatomically, this patient needs to go to the cath lab. And we're seeing anywhere from 17 to 39% negative FFRCTs that can be managed medically.

So I think there's a huge amount of value in both ends of the range. I think we're mainly talking about the upper end with perhaps the adjustment on the lower end from 50 to 40. And it also helps a lot of times, you know, you'll have, well sometimes you’ll have single vessel disease and a lot of times you’ll have multi-vessel disease. And you'll have two lesions that are in question and turns out only one of them really needs to be fixed. So I think preparing yourself to go in the cath lab and know what you're going to be doing ahead of time, cutting down on time, and, again, avoidance of those unnecessary procedures. That's where our biggest value has been from a hospital standpoint and population health, just as an example for our ER patients. We're now going to be getting, have the ability to do this as well, but in general CT if they've got a cardiac CT angiogram done and they come in with chest pain, about 80% of those patients are discharged home from the ED without being admitted, and before we implemented our program, about 80% were being admitted and getting heart caths and nuclear stress tests, and things like that the next day in the hospital.

It's been a huge cost savings, and it's really providing appropriate medical care for these folks who you have one test that gives you the answer that you need, that you can trust and rely on, and then institute therapy that's appropriate, and sometimes that's medical management.

And sometimes it means yes, we do have to go to the lab, but this FFRCT and CT, and anatomic data is a nice filter to prevent people from going into basic procedures that they don't need. And when you do go in, you know which one needs to be treated. So those are just some general comments, and I'd be happy to answer any questions on any of the other topics that were discussed today.

Dr. Clark:
Dr. Bies, since you brought it up, is that statement then really true that 17% of patients with stenosis 90% or greater are false negatives on this study?

Dr. Bies:
It was the range between 70 and 90. So, I'm not familiar with the data of over 90%. Most physicians that see over 90% would probably not order an FFRCT in that case. They would probably just go to the cath lab, especially if they had symptoms.

Dr. Clark:
The range you gave is 70 to 90%.

Dr. Bies:
Yes, sir.

Dr. Clark:
Thank you. OK, thank you. Any other questions?

Dr. Clark:
Jocelyn. Thank you. Dr. Bies.

Dr. Bies:
Thank you.

Jocelyn Fernandez:
Our next commenter is Dr. Mark Rabbat. Dr. Rabbat, your line is open.

Dr. Rabbat:
Great. Thank you. Can you hear me?

Jocelyn Fernandez:
Yes, I can.

Dr. Rabbat:
Wonderful. Are you able to pull up my slides?

Jocelyn Fernandez:
Yes. I have it. I have it projecting at the moment.

Dr. Rabbat:
Can you go to the next slide?

Jocelyn Fernandez:
Yes, sorry about that.

Dr. Rabbat:
Perfect, OK. On behalf of the Society of Cardiovascular CT, thank you for this opportunity to present on the proposed LCD. My name is Mark Rabbat and I'm Associate Professor of Medicine and Radiology and the Division of Cardiology at Loyola University and I'm the Chair Elect of the Society of Cardiovascular CT Advocacy Committee. Next side, please.

Coronary physiology is the established gatekeeper for revascularization. FFR, or fractional flow reserve, is the gold standard used to invasively identify appropriate vessels for stent placement or percutaneous intervention. Now, using FFR to guide revascularization has been shown to improve our patients' outcomes and reduce health care costs. FFRCT has proven itself as a reliable non-invasive test and can be derived from a static CT dataset. Now, the combination of coronary CTA and FFRCT provides a non-invasive test that offers both anatomic and functional data and has been validated through a number of accuracy studies and multiple large scale clinical trials. Next slide, please.

This is a slide on some of the clinical trials published in high impact medical journals in over 6,000 patients, with up to five years follow-up, demonstrating the safety of FFRCT in clinical practice. Based on this evidence, as Dr. Clark and Rogers had mentioned, the American Heart Association, the American College of Cardiology Guidelines, and multiple other societies for the evaluation and diagnosis of chest pain statement, recently elevated coronary CTA as a Class 1A non-invasive test, and recognized FFRCT as a Class 2A with level of the evidence. And this was published a few months ago. I'd also like to point out that the stenosis ranges included in these trials and in the recent American Heart Association and American College of Cardiology Guideline statement is from 40 to 90% stenosis, not 40 to 70%. Next slide, please.

This is a manuscript we published on the real-world Clinical Impact of FFRCT in practice. I'd like to highlight a few of our findings. This was a study of over 400 patients undergoing a CT and FFRCT diagnostic strategy and for one, FFRCT was feasible with a conclusive result in greater than 90% of patients. These weren't cherry-picked individuals, these were all comers, consecutive patients. Point number two, a diagnostic strategy of coronary CTA plus FFRCT was associated with less invasive coronary angiography in patients with coronary artery disease. Point number three, among those who deferred invasive coronary angiography, there were no major adverse cardiac events, so this strategy was safe. Point Number four: A high proportion of those who underwent invasive coronary angiography were revascularized, resulting in higher diagnostic ICA yield, and more efficient utilization of our catheterization lab resources. So, we're sending the appropriate patients who benefit most for revascularization.

Now, the Society of Cardiovascular CT supports the expansion of the stenosis range, from 40 to 70% to 49 to 90%. And this expansion is in alignment with the updated ACCHA guidelines and will provide more access to appropriate patients. Next slide please.

Not only are we able to use this information from FFRCT as a gatekeeper for invasive coronary angiography, but we're also using the functional FFRCT data to guide appropriate revascularization strategies. This is a patient of mine that we scanned back in 2015 and he was having symptoms suggestive of CAD. On his coronary CTA he was found to have multi-vessel CAD. Based off of the CTA alone, the initial recommendation was to pursue a revascularization strategy of coronary artery bypass graft, so surgery. After having the functional data from the FFRCT, you can appreciate that the right coronary artery and the circumflex coronary arteries had non-flow limiting lesions. So his revascularization strategy was downgraded from a more invasive and costly coronary artery bypass graft approach to a single-vessel PCI to the left anterior descending artery. And I'm very happy and proud to say that he's been doing very well since and he hasn't require any further intervention. FFRCT definitely has a role in multi-vessel disease and severe stenosis, and it ranges of 70 to 90%. Next slide, please.

This slide represents the proposed list of exclusions. For the majority of cases, prosthetic valves and prior permanent pacemakers and defibrillator leads do not alter image quality of the coronary arteries. Thus, the Society of Cardiovascular CT is requesting removal of exclusion numbers one and number eight. We recommend removal based on image quality review by Heartflow. Heartflow reviews all images and if the CTA image is not adequate to create an FFRCT, the image is returned and there is no charge. Next slide, please.

These are the Society of Cardiovascular CT recommended exclusion and inclusion criteria for consideration. Again, as Dr. Rogers had mentioned, Heartflow reviews all the images and if the CTA image is not adequate to create the FFRCT, the image is returned and there's no charge. The Society of Cardiovascular CT recommends only excluding anatomy that would affect human anatomic accuracy. Contemporary data demonstrates the safety and feasibility of FFRCT in aortic stenosis. Therefore, we recommend that aortic stenosis is OK to include. We recommend exclusion of non-ST elevation myocardial infarctions, ST elevation myocardial infarctions, and unstable angina, less than 30 days. We also recommend excluding new systolic heart failure with no prior invasive catheterization. As stated previously, SCCTs recommendation is to remove the exclusions that relate to image quality, such as number one, prior placement of prosthetic valves and number eight, prior pacemaker or defibrillator lead placements. In regards to inclusions, we support expanding stenosis ranges with coronary stenosis of uncertain functional significance to 40 to 90% diameter stenosis. Now, this next point is not on the slide, but the SCCT also suggests removal of the last statement in the support paragraph regarding high plaque volumes as high plaque volumes do not necessarily impair CCTA image quality.

The adoption of FFRCT to our CTA programs has transformed the way we diagnose and manage our patients with CAD. We're picking up disease that we've been missing with standard of care testing, and our patients are now feeling better. At the same time, we're also able to safely avoid many unnecessary invasive cardiac procedures with addition of FFRCT.

On behalf of the Society of Cardiovascular CT, we'd like to thank you for the opportunity to share our suggested revisions and for your support. Thanks again.

Dr. Clark:
Thank you. I do have a question that has been forwarded and I think it deserves attention since you're the represent representative of a society that may have influence in this. We really commend Heartflow for their quality in imaging analysis and commit or pledge to do the right thing here. Do you think all of the other technologies would join in that commitment and would you be willing to help develop that?

Dr. Rabbat:
If you could repeat the question. I'm trying to understand the question.

Dr. Clark:
Sure. The question is that Heartflow makes a commitment to the review of satisfactory imaging for analysis, which is really commendable. Do you think, perhaps, with the use of your society's influence, that other manufacturers will join as well?

Dr. Rabbat:
Absolutely. So we would recommend that they would maintain the same standards of high image quality in order to improve the diagnostic performance and accuracy that translates into improvement in outcomes for our patients. So we would definitely support that.

Dr. Clark:
That’s commandable. Thank you. Thank you, everybody, and unless there are other questions or comments, I will turn it back to Dr. Oakes.

Dr. Oakes:
OK, thank you Larry, appreciate that. Very nice presentations by all.

Any comments Jocelyn before we move on to the next big next line of speakers, I should say.

Jocelyn Fernandez:
No.

Dr. Oakes:
OK, so we didn't have any public stand-up comments for…

Jocelyn Fernandez:
Dr. Oakes, sorry. There's two more commenters for FFR.

The fourth commenter is Dr. Sammy Chu. Dr. Chu, your line is open.

Dr. Oakes:
My apologies.

Dr. Clark:
Mine too. Sammy, I thought you were on one of the other topics of all people. I am sorry. Thank you.

Dr. Chu:
No. No worries. I signed up for two topics so this will be my first one, but I will actually make this one quick. My name is Sammy Chu. I'm the current President of the Washington State Radiological Society and also a CAC Member for Radiology for Washington State, and the Chair of the CAC Network for the American College of Radiology.

I am actually going to defer my time to Dr. Geoffrey Rubin from University of Arizona since he is a much better expert on this topic than I am. And I want to report that WSRS and ACR are in agreement with his comments on this particular LCD. So I will defer my time to Dr. Rubin.

Dr. Clark:
Thanks, Sammy.

Dr. Chu:
Thank you.

Jocelyn Fernandez:
Dr. Geoffrey Rubin, let me unmute your line.

Dr. Rubin:
Hello. Oh. Great. Thank you. Thank you very much. Are you able to hear me?

Jocelyn Fernandez:
Yes I can.

Dr. Rubin:
OK, hi everybody. My name is Geoff Rubin, and I am from the University of Arizona Currently, I am asked to speak on behalf of the American College of Radiology as Dr. Chu just mentioned. I have been involved in the development of both the technology and the applications of coronary CT angiography since its very earliest days in the 1990’s. And I welcome this opportunity to contribute. Just a very focused additional perspective. I want to say that the comments, in particular, Dr. Rogers and Dr. Rabbat provided, I fully stand behind and I think, are all very strong and important statements to take under consideration from the ACR's perspective. The one area that I wanted to just focus on is the addition of the statement that Dr. Rogers also emphasized about not performing FFRCT in conjunction with stress testing. This is an additional statement that is added at the end of the LCD, and I think that the concern that I want to raise to the committee, in particular, is to be sure that the term "in conjunction" is not too vague to allow for the exclusion of FFRCT in patients for whom stress testing may have been attempted, or even performed, but was not completed or non-diagnostic.

And because of the fact that many patients who have an indication for FFRCT and coronary CTA may also be candidates for stress testing, and because that stress testing may not necessarily be conclusive or satisfactory, it would be most unfortunate if that were a exclusionary factor in subsequent performance of coronary CTA and FFRCT.

So, I just really want to emphasize the point that certainly, you know, the two tests should not be performed simultaneously, and it would be essentially impossible to perform them simultaneously. But most specifically, I would advise the committee to apply language that does not exclude coverage for FFRCT in the setting of a stress test that is unsatisfactory, non-diagnostic or simply does not provide sufficient information to satisfactorily triage the patient and, therefore, FFRCT and CCTA should be performed.

That was really the one point that I just wanted to focus in on, and I'll just, you know, again, emphasize the many points shared by Dr. Rogers and Dr. Rabbat are excellent points, and we certainly agree with those, but, in particular, just wanted to be sure that we were not becoming overly exclusionary in the setting of the uncertainty that may occur around stress testing.

Dr. Clark:
Thank you. Any questions? And if not, Jocelyn, I think we are going to wrap up on this topic.

Jocelyn Fernandez:
That's correct.

Dr. Clark:
Great, thank you.

Jocelyn Fernandez:
Dr. Oakes.

Dr. Oakes:
OK, thank you, Jocelyn and again my apologies to Dr. Rubin and Dr. Chu, I appreciate you hanging in there with us.

Our second proposed LCD is a molecular diagnostic one of Plasma-Based Genomic Profiling in Solid Tumors. But, that said, we had no commenter sign up. So, we'll move on here promptly to Dr. Goldzweig to take over for Epidural Steroid Injections please.

Dr. Goldzweig:
Good afternoon, everybody. I'm Dr. Peter Goldzweig and we are here for the Epidural Steroid Injection LCD. And Noridian is considering joining the other contractors in adopting a more collaborative work group policy on this subject. So, with that, I would like to begin and introduce the speakers. And please, just as a reminder, each speaker, if you could say if you have any conflicts. The first speaker is Dr. Stan Helm.

Jocelyn Fernandez:
Dr. G, Dr. Helm has not signed in. He has another commitment so we can move on to Dr. Sammy Chu.

Dr. Goldzweig:
That'd be great and then if he gets on, after Dr. Chu, we could have an opportunity to hear from him then.

Jocelyn Fernandez:
Yes. Thank you.

Dr. Chu:
Hi, Sammy Chu. Can you guys hear me?

Dr. Goldzweig:
We can, so please, feel free. Go ahead.

Dr. Chu:
All right, thank you very much. Again, I'll introduce myself, Sammy Chu, current President of the Washington State Radiology Society, CAC member in Washington State for Radiology and a practicing neuroradiologist in Washington State and also currently the Chair of the CAC Network for the American College of Radiology.

I want to thank all the Medicare Contractors for developing the LCD on Epidural Steroid Injections and Interventions. In review of the policy, I really only have one comment and that's with regards to the limitation on ESI injections for a maximum of a 12-month period. Well, I admit, I don't do many epidural steroid injections, but that is part of my practice. And I have found benefit for patients where by the ESI's are continued for a period longer than 12 months.

I think we certainly need to be wary and considerate of the potential complications of long-term use of steroids, but I think a 12-month period is probably too short. I think if the contractors and Noridian can consider extending that for a longer period, perhaps 24 months, I think it would be more appropriate. There are probably other practitioners who would suggest it could be extended longer than that, and I will defer that for their comments. But I think really the only comment that I had on the LCD was that I think that the 12-month period is too short a period. So thank you very much again for the opportunity to participate and comment on the LCD.

Dr. Goldzweig:
Thanks again, Dr. Chu. And if you don't mind, please just send all your comments in, so that we have a record of it and we can address it, that'd be appreciated.

Dr. Chu:
I will submit it by deadline. Thank you.

Dr. Goldzweig:
Jocelyn, if I remember correctly, that is it for commenters?

Jocelyn Fernandez:
Yeah, let me check.

Dr. Helm, if you are signed into the meeting, can you please use the raise hand function so we can identify you and unmute your line?

Let's give him a moment.

Dr. Goldzweig:
You got it.

Jocelyn Fernandez:
OK, I don't see any hands raised so we can conclude the meeting. This concludes the presentation portion of today's meeting. We will now move on to closing and next steps.

Dr. Goldzweig:
And if I could just take a second and just thank everybody who has reviewed made comment, put any effort in this LCD once again. Thank you for all of your time and your effort.

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

The comment period for the proposed LCD will remain open until March 5, 2022 for Non-invasive Fractional Flow Reserve for Ischemic Heart Disease and for MolDX Plasma-Based Genomic Profiling in Solid Tumors. The comment period for Epidural Steroid Injections for Pain Management will end on March 26, 2022. All comments to be considered by our Medical Directors for the proposed LCDs must be submitted in writing. All 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. 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 over to Dr. Oakes for final remarks. Dr Oakes.

Dr. Oakes:
Thank you, Jocelyn, and we do certainly appreciate, echoing what Dr. Clark and Dr. Goldzweig said. We do appreciate your taking time out of your quite busy days to come help us get the best policy out there, because I think we all have the beneficiary’s best care at heart.

Thanks for attending. This does conclude our open meeting today, and we wish you all a very nice evening.

Thank you.