Non-Invasive FFR for Stable Ischemic Heart Disease Open Public Meeting Transcript - November 12, 2019 - JF Part B

LINDA MEYER
Uh we'll go ahead and get started. Um thank you for attending the meeting for the Non-Invasive Fractional Flow Reserve for Stable Ischemic Heart Disease Open Meeting. I'm Linda Meyer and I'm the Medical Policy Manager for Noridian. Um I am not Dr. Clark who is on the phone, but um as some of you may have heard, anybody who came to the meeting through Chicago yesterday um had trouble getting to Fargo. So, we uh do appreciate everybody's flexibility with either calling in um, and I think we'll have a successful meeting regardless of where everyone is located. Um I just want to make sure um, Tom, from our - assisting with our meeting, are you able to hear me?

TOM JONES
We have you.

LINDA MEYER
Okay. I want to make sure the audience can hear. Oh, today we have uh three presenters uh that will be, um that have opted to communicate on behalf of this policy. And as a reminder to those who are speaking and those who are listening, all comments that need to be considered by our Medical Directors for consideration in this LCD development process must come in in writing, and I do have some information at the end of the presentation as a reminder so you can submit those comments and the deadlines to submit those comments. But this is a reminder, um while we do appreciate your comments here, they must come in in writing to be officially considered for the LCD consideration. With that I will turn it over to - um can we go to the next slide please? And we'll go ahead to the next slide, and we'll introduce our first presenter. Our first presenter is, he's on the phone, Dr. Campbell Rogers. Um he also was one of those who had troubles in Chicago, so Dr. Rogers are you on the phone?

DR. CAMPBELL ROGERS
Yes, I am. Can you hear me okay?

LINDA MEYER
We can hear you loud and clear. Thank you for um linking with us and making sure that you are able to speak, even if it's um via teleconference. But please go ahead with your presentation. And when you want to transition to the next slide just hit next and our um assistant will go ahead and transfer your slide.

DR. CAMPBELL ROGERS
Great, will do. And thank you for accommodating this without being there in person. Again, I was actually looking forward to coming to Fargo, believe it or not. True statement. So, I apologize for not being there in person. And we very much appreciate the opportunity to uh present some aspects as we read through the LCD that from the vendor's perspective may be important for Noridian to consider. Uh these of course, just as you instructed, will all be submitted in our written comments uh as well. If we could go to the next -.

DR. LAURENCE CLARK, MD, FACP
Dr. Rogers? This is Larry, I just want to say thank you for the extra effort in being here. And we are going to give you an extra couple of minutes. I do want to remind anybody else on the line we are talking about Noridian DL38465. So, if you want to pull that up on your computer and reference this as Dr. Rogers is speaking please do, and thanks again.

DR. CAMPBELL ROGERS
Great, thank you Dr. Clark. So just as an outline of what over the next few minutes the key points that I wanted to raise for consideration. Uh the first bucket of items will be in the Exclusions. There are a couple of additional Exclusions we would like to suggest for consideration. And then there are some revisions to those, which are posted in the Draft LCD, we would like to speak to. The second is in terms of Indications. Again, there are some suggested revisions based on the published literature we'd like to highlight. And then finally, just one comment on the Billing and Coding Document, which accompanied the LCD, the Draft LCD. If you can go to the next slide please?

As a reminder, and this will be the backdrop for many of the uh observations in this presentation, is the decision-making in the pathway which is under consideration involves first a decision whether or not to do a coronary CTA, and that really has not been part of our, uh that is not the topic of uh our presentation this morning. What is the topic is which patients then may be chosen for a second test with the HeartFlow FFR_CT Analysis. So that green circle is just to sort of highlight where much of this discussion rests. If you could go to the next slide please?

This is the list of current Exclusions in the Draft. Uh, I'll just - we are going to address each of these eight, so I put this just here for a reference. And again, we'll come back to each of these, not quite in this order, but in one way or another over the course of the next few slides. In addition to these eight, if you go to the next slide please, there are two that we would like to suggest, which are not present, but we believe should be. They were - this relates to both what uh information, or to what our technology indications are and where we are able to process cases and where we are not, where our clinical trials have been and where they have not. The first is that in our clinical studies we have excluded patients with recent myocardial infarction within the past 30 days prior to the CTA being acquired. So, we think that's an important uh thing for Noridian to consider. And the second is that uh some patients who have prior metallic coronary stents are excluded from our processing; they will be uh rejected out of hand. And the details uh are included on this slide. I won't read through them, but they are here for reference, and they will be in our written comments about which cases with prior coronary stents are in fact excluded. And we believe that's an important thing to capture in the, uh in the LCD. If we go to the next slide please?

In terms of revisions to the current Exclusions we are going to go through, as I mentioned, the eight that were mentioned before, not quite in the order. The first relates to Number 7 which is "Prior placement of venous grafts in coronary bypass surgery." We exclude all patients who have had prior coronary bypass surgery, including those with arterial grafts. So, we would simply modify this exclusion criteria to be more comprehensive and excluding all patients with coronary bypass surgery. Those patients have been excluded from our clinical studies and are not within our current capabilities. The next is Number 8, which is "Suspicion of acute coronary syndrome," and uh this one has been, uh there has been wording used uh elsewhere, which is more in keeping with both the clinical use as we see it being used in the marketplace, as well the clinical data, which is uh that the exclusion is for acute coronary - we believe should be for acute coronary syndromes where acute MI or unstable angina have not been ruled out. Go to the next slide please.

Number 4 relates to "Renal insufficiency with a benchmark of GFR of less than 60." Uh we believe this should be removed. This is, of course, a relative contraindication or a consideration in the acquisition of coronary CTA, because of the intravenous contrast which is required for that exam. For the FFR_CT component there is no additional contrast required. Uh and the sort of medical observation I would make is that there are patients in whom the use of FFR_CT may help avoid a trip to the cath lab where, of course, intravenous contrast will be administered again. So there, we believe there is not a justification for excluding these patients as long as their uh CT images are of sufficient quality. And we'll come to that point in just a second. The next one is Number 5, which is worded currently as "Known severe aortic stenosis." This again we would suggest removing. Uh without going into detail at all, but happy to if there are questions. Uh part of our uh process includes assessing myocardial mass, the mass of the left ventricle which increases in patients with aortic stenosis. And that is uh accommodated in patients, yeah in patients going through the FFR_CT analysis. So, we believe that there isn't a reason to exclude patients with severe aortic stenosis. Again, if their CT images are of sufficient quality, a point we will come to in just a second. We could go to the next slide please.

These three are going to be spoken to together. I'm going to go into a bit more depth on this notion of the quality of CT images: how heartflow uh uses this, and I use the word quality in terms of our specific process; how we assess this. That is a backdrop for the three current Draft Exclusions you see here, "Severe Obesity with a BMI over 35," "Prior placement of prosthetic heart valves" and "Extensive coronary calcification." So, all three of these will be uh in the backdrop for the next few slides. If you go to the next slide please.

This describes in some detail what HeartFlow does when incoming CTA image datasets are sent to us, and the data quality inspection which takes place. And again, we'll not go through this in detail. All of this will be included in our written comments. But suffice it to say that the first step is very - above the horizontal line, review of specific technical criteria to ensure that we have complete datasets with adequate resolution. You see some of the specific uh technical requirements on the right, and I won't read through those in detail. The second is below the dash line, is that then every major vessel is reviewed and graded for image quality. And again, quality is very specific. The lens we look through is what we need in order to provide within our uh FDA-approved indication, what uh we need to in terms of FFR_CT analysis. So again, the details are listed here, and I would highlight that when a quality assessment is done, and the scan fails our quality assessment, there is no FFR_CT analysis completed. Information goes back to the site with the reasons for which the CT failed. And of course, we then have uh a team which engages with the site to perhaps help them acquire images that may be more suitable for FFR_CT analysis the next time. Most importantly, or perhaps most importantly, there is no charge, there is no cost associated with this. If we are not able to perform the analysis, there is no charge or cost associated with it. If you go to the next slide please.

I put in there are three slides, and I'll go through them quickly, just to demonstrate images so that sort of to put a picture on this. What you see here are three images going from left to right. You can see the quality of the ability even for a lay person to understand the luminal anatomy uh is clearly different across these three. Um and the luminal anatomy is essential for the FFR_CT process. So, this is an example of sort of from, from good to bad. If you go to the next slide please.

This is again identification on the left of image quality which would be unacceptable in excessive artifacts. You can see that the lumen boundaries are vague and very hard to determine. Uh on the right, in contrast, is a vessel which has good resolution, we were able to provide the FFR_CT analysis from that CTA image dataset. If you go to the next slide please.

Finally, specifically to coronary calcium as that was one of the exclusion criteria, uh coronary calcium has been a major focus for us in terms of our clinical data publications. And what you see at the bottom is from, from uh the literature where we will provide in the written comments the details behind this. But for scans which pass our incoming CTA image data quality inspection, accuracy is preserved across all of the calcium score values. So, there does not, uh there has not been defined a calcium score threshold above which or below which our accuracy of our product varies. It is certainly true that some patients with heavy calcium will be rejected for CT quality, but again as mentioned, there won't be no FFR_CT return for that and there is no cost associated with that. If you go to the next slide please.

So, the suggested revisions for these three would be for "Severe Obesity," to remove the Exclusion. If the CTA image data quality is unacceptable, there is no FFR_CT processing and no charge. "Placement of prosthetic valves" we didn't speak to specifically but the same pertains. And finally, "Extensive coronary calcification" uh from an FFR_CT perspective does not seem to be, we believe, does not belong as an Exclusion. I would point out that other MACs have managed coronary calcium through their CTA LCDs, and we've listed those, and will include those in our public comments. Will you go to the next slide please?

Then the final piece to talk about, uh and then we'll be finished, and I really appreciate the opportunity and the time to do this presentation, is the suggested revisions to Draft Exclusion Number 4 as well as the Indications. And we've bucketed these together. Exclusion Number 4 says, "Exclusion is known severe 3-vessel disease." The indications as listed, and again I won't read through them, are relatively specific in terms of specific vessels with disease, and the degree of stenosis which those vessels should carry in order to meet indication for FFR_CT. Uh and again, I won't read through them in detail. I would point out that one example, it's not the only that falls out, is that for example, if a patient had solitary right coronary artery stenosis, that that would not be within an Indication, just as an example. The final point I would make is that Number 4, "Proximal 2- or 3-vessel disease with intermediate stenosis", of course, is at conflict with Exclusion Number 6. So, there needs to be some resolution of those two items one way or another. If you go to the next slide please. Uh and if you could hit return twice so that this fills out please? This is a building slide. Actually, I'm sorry, just go back. Please, please go back to where the green circles are showing. I apologize. That's perfect, great.

The point I wanted to use make here is the following. These are literature from the Advanced Registry, which enrolled approximately 5,000 patients, and in a per vessel basis looked at the degree of stenosis, and by CTA, as read at the site, so just as would be the case in real world clinical use; and the level of FFR_CT positivity or negativity. And the point I wanted to make is each of these is, each of the three graphs is, one of the three major coronary distributions: LAD, left circumflex or right coronary artery. In the middle, circled in green, are patients who had a stenosis in that vessel of 50 to 70%. And you can see that depending on the vessel, uh which vessel, somewhere between one-third and two-thirds of patients within that band will have a negative FFR_CT. Those are the red bars and that's in the red box at the top. If you go to the next, hit return one more time please. Hit return again. Great.

What you see here are patients who have a stenosis of 30 to 50%, so less severe. And again, you see that the patients who have um in the, I'm making this a little bigger so I can see it, in patients who have less than 50% stenosis there are many patients who actually have a positive FFR_CT. Not a trivial number, nearly half of patients with LAD stenosis in that regard, and a fifth to a quarter of patients in the other vessels, despite having only moderate stenosis, will have a positive FFR. And then finally if you hit return one more time please.

In patients in the 70 to 90% stenosis range, although one might think surely all of those patients will have a positive FFR, we don't need to do the test. It turns out that somewhere between one in five, you know one in three patients, depending on the vessel, nearly one in two for the circumflex, will actually have a negative FFR_CT despite having stenosis in the 70 to 90% range. And therefore, one could envision that the information provided by the FFR_CT would be of importance to their clinicians. If you can go to the next slide please.

The final point on this topic, and hit return one more time please, is in this same registry we looked at decision-making in the 70 to 90% stenosis, decision-making as ascertained at the time of care, and found that in the range of 70 to 90%, over 80% of patients had greater diagnostic clarity with the use of FFR_CT than had been the case with the CTA alone. And hit return one more time please.

And 62% of patients in this stenosis range had a different management plan after the FFR_CT than they would have had after the CTA alone. So, the impact on decision-making in this range of stenosis is not to be underestimated. The next slide please.

Finally, in terms of 3-vessel coronary disease, and we will include this paper in our written comments, there is a publication specifically looking at the clinical utility of FFR_CT in 3-vessel coronary disease. This was one of the exclusions, but again in this sort of internal uh paradox was included in one of the Indications. So, we would uh suggest that it should be included as an Indication, it should not be an Exclusion. And we'll include this information. If you go to the next slide please.

So finally, to close on the Draft Exclusions and Indications, our suggestion for Exclusion Number 6, "Known 3-vessel disease," is to remove this Exclusion. And for the Indications to revise them to be "Coronary disease with coronary stenosis of uncertain functional significance and a luminal reduction between 30 and 90%." If you go to the next slide please.

The final topic is that of Billing and Coding, the Draft Billing and Coding Guide has a single ICD-10 code. We wanted to highlight that other LCDs from WPS, NGS and Palmetto have more comprehensive lists of ICD-10 codes, and it would be our suggestion, if you go to the next slide please, that uh that the restriction of ICD-10 codes to a single code could lead to inadvertent denials and access issues for Medicare beneficiaries. Uh the coding and billing protocols in institutions could be complicated as the proposed code does not uh appear on some health plans' list of approved indications, just for your consideration. And we would suggest uh, you know, uh considering similar lists to what Palmetto or the other MAC LCDs are currently, have published. So, with that, that's my last slide. Again, thank you very much for the opportunity to bring these issues before you for discussion, and we will of course submit these in written comment form as well. Thank you.

DR. LAURENCE CLARK, MD, FACP
Uh thank you for a great presentation. Um if I may just, I really appreciate the fact that uh one of my questions having seen your slides in advance, uh and I thank you for that too, is the concept of the syntax score and the 3-vessel CAD. And you said you were including a reference that we had not included. And so that, that is exactly what we should, what we should be doing with this meeting. I do have a couple of thoughts that I hope you will follow-up on in in writing. Um one of them that, that strikes me is, um you know, we are going to have to discuss your uh I think slide 24 in, and 23 because it looks as though those are in some ways symptom codes. And very much as you pointed out, the incorrectness of our bullet, I think it was Number 6 that referenced GFR and contrast, those diagnoses appear to me to be ones that would lead to the initial decision-making of performance of the CCTA, and not the post-procedural data analysis of the um, of this FFR_CT. So, I think there is an inconsistency there that we need to resolve going forward.

And I think my um, I'm just going back through the notes. Yeah, my, my last comment is that I don't think, and I'm going to have to go back and listen again through about um two and a half, three hours, I was wondering if you were on the call, it was unfortunately back June 18th when we had the corresponding uh CAC. And we proceeded to go forward with this because of the many comments that we received that day, but I thought I received some comments about the Myocardial Infarction Exclusion and the Metallic Stent Exclusions that um clinicians there actually were arguing against those uh Exclusion Criteria. So, I polled them to elicit comments and, you know, I'm sort of wondering is it possible because some of them were academicians from different centers? I do know there are some other uh products, some other, and I don't know their proprietary status. But there are institutions who are building the FFR_CT into the CCTA. Um is it possible they were referencing other technologies when they did that? I've really got to go back and focus on that. And the other thing that I'm learning about is a thing called instantaneous wave-free ratio, which appears to be sort of a new and evolving technology, and I'm wondering if that will be using the same codes as well. So, you know I just think there are now some new wrinkles that are entering the picture. But I just want to reassure you that the myocardial infarction 30 day and the um the metallic stents was not done without somebody prompting us to do that.

DR. CAMPBELL ROGERS
Sure. And if I could just comment very quickly from the HeartFlow perspective. Again, I believe there are clinicians on the line who can comment. The reason we raised those are two. I'll take them in order. For our specific FFR_CT analysis, which is the only commercially available one today, we in our clinical studies excluded patients who had had a true myocardial infarction, proven MI in the last 30 days, we cannot attest to the accuracy of our product in those patients. In terms of stents, it is not a wholesale preclusion but there are certain stents in certain vessels which we will automatically reject out of hand. And that's what I capture on that slide and will be in our written comments. It's not a wholesale ban but it's a subset of stented vessels.

DR. LAURENCE CLARK, MD, FACP
Are you sure that you are the only product available?

DR. CAMPBELL ROGERS
Yes. And iFR is an invasive technology, so that's with a wire. That's more akin to invasive FFR. Yep, you bet.

DR. LAURENCE CLARK, MD,. FACP
Got it, thank you.

DR. SLIM
Hi.

DR. LAURENCE CLARK, MD, FACP
I'm sorry, someone else was asking? Yes?

DR. SLIM
This is Dr. Slim. I don't know if your call, I was on the initial phone call. I was the prior Chair for Efficacy for SCCT and I worked on the initial code for CT FFR and some of the science behind it. Just to answer two of the questions. I think some of the concerns from academic centers is MI in a different distribution vessel if they were looking at a completely different vessel. But still within 30 days it might be concerning because of the change in the morphology. Uh that's number one. Uh number two, in regards iFR, I work on the ACC Coding Taskforce and that would be a completely different mechanism and a code that would fall more um along a different code that's being evaluated. Uh but going back to the initial discussion that was brought up, I agree with the HeartFlow folks in regards to uh looking at a lot of the Exclusions. They fall within the mechanism of CCTA, and uh some of these are a little bit of an older Exclusion depending on the machine that's being used, whether it's a first generation or a third-generation machine. So, I think they should probably fall into more or less a separate LCD for uh calcium scoring and CTA by itself, independent of CT FFR. If the images were obtained and they looked great, um it would actually save these patients from undergoing additional testing. And my biggest concern is the Exclusion of the RCA lesions. Um at the end of the day these are symptomatic patients, and if anything, we want to know if they have disease or if they do not have obstructive disease so we can manage them appropriately. And to, you know, to look at them and simply say we can evaluate LAD and Circ, but we can't do RCA, which is, it's a little bit odd. Um, I know it might be that the thinking was involving I guess CABG, patients with LAD disease. But that would be far, far off on the population that we are looking at. These are patients that underwent testing, they have a lesion that we are looking at. And it would help us not to put them through another test if we can identify whether it's an obstructive lesion or not, and whether we need to even treat them medically or not. So that's my two cents in regards to the slides that were brought up.

DR. LAURENCE CLARK, MD, FACP
Right, thank you. And, again, I realize it's an added burden, but I think they are very valuable points. And if you would commit that to writing I would really appreciate that so that, you know, the absolute understanding is there. This is being recorded, but having that absolute understanding would be of value. And thank you. And I've added some time obviously here as the moderator trying to understand a few things, so I'm going to turn it back. Linda, if you want to introduce our next speaker? Ms. Brown? Linda, are you there? Hello. Hello.

CAMPBELL ROGERS, MD
Yeah, Dr. Clark, this is Campbell again. Heather Brown is one of my colleagues. She did not have a separate presentation. I apologize.

DR. LAURENCE CLARK, MD, FACP
Oh, okay. Sorry. No, no problem. We gave you time in case, okay. Linda, are you there? Okay, is Dr. um - I want to -

LINDA MEYER
Can you hear us now? Can you hear us now?

DR. LAURENCE CLARK, MD, FACP
Yes, yes, you are back. Good. Okay, Ms. Brown is just -

LINDA MEYER
Somehow our line got muted.

DR. LAURENCE CLARK, MD, FACP
Okay, let me tell you that um we just ah concluded an interchange and uh Ms. Brown's um comments are essentially um part of Dr. Rogers'. So, I'm going to just give a brief um introduction here. Uh Dr. Wright went through the Conflict of Interest process, and um has also been a clinician with a significant track record of contribution to what we had traditionally called our - and yes, and here are his credentials and experience coming up. And he had worked with our prior CAC process for a number of years. He was unfortunately excluded despite his efforts by technological problems from our original call back on June 18th. So, in fairness and transparency we wanted to make that up, and we appreciate um his willingness to be with us today. So, go ahead. Linda, if you could introduce Dr. Wright.

LINDA MEYER
I was going to say I think you did a great job, Dr. Clark, so we will go ahead. Dr. Wright, are you on the phone? Can you hear us?

RICHARD F. WRIGHT, MD, FACC
Yes, I am, can you hear me?

LINDA MEYER
We can hear you wonderfully, great. We have great - so please go ahead and um, go ahead.

RICHARD F. WRIGHT, MD, FACC
So, some of what I've said, what I would like to say has already actually been commented on. And that is um one of my issues with the whole field is the proscriptive nature of these LCDs. For example, to have uh an LCD that says we will never pay a fee, creatinine clearances estimated at less than 60 mils per minute. Or one of the comments in the LCD that says if someone has had FFR by CT that Medicare will, in that circumstance, not pay for a catheter based FFR, I think is a big mistake. And the reason for that is that uh there are both false positives and false negatives in all of these. So, I'll give you a perfect example of a patient of mine last week who had an FFR CT of .67, but when we took the person to the cath lab we couldn't find a lesion that could possibly explain a .67. And we repeated in the lab um you know a pressure-based catheter method of FFR and the FFR was .85. And hence in that case we avoided putting a device in a person because the information had been misleading. And although that's the minority of cases, if you look at the positive and negative predictive values of any of these methodologies, whether it's HeartFlow or whether it's CT, there are outliers. And I think it's a mistake in the, uh in the actual LCD to say we will never pay for the following cases. And others have commented about this, as the generations of uh both software and hardware get better, to say that you won't pay to cover obese people, or people with low GFRs, etc., I think is a huge mistake because it's harder to go back and change these things.

Now that said, uh my other comment about this was also alluded to, and that is I think the document is inadequate in saying which patients uh is this technology, or are any of these technologies not useful in, because they all depend on uh inferences uh depending on the size of the vessel and length of the vessel. And some of this is commented on in the proposed LCD. For example, patients with coronary bypass surgery, uh the comments earlier about patients with stents. Obviously, if somebody has three stents in the right but now we are looking at an LAD lesion, that's not a problem. But if somebody has seven stents in the LAD, none of the current methodologies are that helpful; the non-invasive methodologies are that helpful in such a patient if the LAD is the, uh is the vessel of interest. So, I'd like to see that fleshed out a little more rather than just having uh, you know, a yes, no, we will pay, or we won't pay in these. And I realize there are a lot of gray areas in this arena, but that's how medicine is. I do think that these technologies are very useful, although I also think that they are in evolution. And as somebody said there half the different way, half a dozen different ways of measuring FFR. And I'm not sure which will win out in the end in the marketplace, but that's my two cents about the utility of it. When it will come to the RUC for pricing, uh I will tell you ahead of time, we are going to have issues with how to price this kind of thing. Um but for now, uh I'm going to limit my comments to the clinical utility. And I'd be happy to address any issues people have about this.

DR. LAURENCE CLARK, MD, FACP
I hear the wisdom of the experienced clinician, and uh I really like your comments about the difficulty of policymaking, and also your, your sympathy in terms of trying to develop policy in evolving times and competing technologies. Yeah, that's one of the good things about this job is you learn something every day. And uh I'm very interested, a couple of the uh policies that are mentioned in the Rationale for Determination talk about the comparison of FFR by wire, and now I guess I'm learning about the uh instantaneous um wave free ratio. Um do you feel that the wire is going to remain preeminent? I mean it does seem like this noninvasive technology may spare, I mean it does seem to alter patient management. What do you see happening? And I realize it's purely conjecture on your part, sir.

RICHARD F. WRIGHT, MD, FACC
I think there will be a role for most of these. And some of it is going to be determined, as was alluded to earlier, and in the documents from the companies themselves, will depend on the economics of it. So, if all uh PCIs are bundled, and therefore there is an economic incentive to avoid the procurement cost of a wire, for example, then one can make uh an economic argument for the institution uh to use, predominantly use, these noninvasive methods. That said, I think there will always be a role, whether it's instantaneous or whether it's the more traditional wires, I think there will always be a role in it as the case I said from our own institution last week, there will be cases that just don't make sense. And therefore, you need additional corroborative data, uh which most people believe would be cath lab based. And the reason they do that is because all of the proprietary technologies are a bit of a black box, and as much as, if you go into any cath lab in the United States and start talking about these laws of physics, and believe me I took a semester of flow rheology at MIT, and the flow is so different in a pipe compared to an artery. Most clinicians would prefer to actually put a catheter down an artery and measure things. So, I believe that's always going to be the gold standard, as good as these noninvasive methods are. That said, do I think the noninvasive methods will replace many of the wires? I do, actually.

DR. LAURENCE CLARK, MD, FACP
Okay. So, in that regard, I think you are synergistic with all of the speakers of that day. And I do appreciate the fact that you also brought back into clear recollection your example of the vessel of interest. That was exactly what we discussed on June 18th was the fact that there was a stent or multiple stents in one vessel; but the vessel of interest, the distribution I guess in terms of EKG change or imaging change, and you know concerns over recurrent symptomatology, that that's what led to the FFR_CT even with the stents being there. Do I now have that right in my head, sir?

RICHARD F. WRIGHT, MD, FACC
Yeah, you do. And as one of the other commenters had stated earlier, um the issue about the MI, I mean the problem with coding for MIs these days is virtually anyone that has a troponin elevation is coded as an MI. So, uh in the HeartFlow uh databases most of the patients in fact have either progressive angina or unstable angina. I'm certain some of them, and a lot of them, had non-ST elevation MIs, so they had some form of leak of troponin. But as you say, many times you are going to come in, and the culprit vessel uh by angiography is in the right, you do a stent, but there are lesions in the LAD or Circ that you are not certain of. Perhaps you've used up your contrast, and that you've decided on another day you are going to determine are those significant lesions? And what you would turn to in fact is a technology like this. So to say you can't use that within the next 30 days I think is a mistake, because there will be people in vessels, other vessels of interest where you are trying to use the methodology to determine, you know, the importance of that. And historically that's always been using um some kind of radionuclide study or some similar PET scanning or something to determine whether there is ischemia. But now we have these methods that may allow us to not uh use those techniques.

DR. LAURENCE CLARK, MD, FACP
Thank you. And thank you for the effort to get back here and those really germane comments. And now, and I just absolutely these past 40 minutes have flown. And you know every time I discuss this study, you know this is honestly not my background, so I appreciate people who are kind of - but we do have that kind of background within Noridian. So, I think our, uh our final policy is going to reflect um, reflect the state of where this technology is. At least I hope so, that's what we are supposed to do now. And the next step, and Linda, correct me if I'm wrong, or go through this in your planned closing remarks, I think you have up until December 15th to put in written commentary and please elucidate those very issues. And Dr. Rogers, the added syntax score um reference that's again, that's where, you know, it's fascinating that you start down this process, and by the time you think you've gotten somewhere things are even evolving. But with that being said, Linda, would you pick it up from here? And thank you, everybody.

LINDA MEYER
Absolutely. Thank you, Dr. Clark. Um as you can see on the screen those who are um viewing our presentation, Dr. Clark is correct, our Comment Period is currently open, and it does end December 15th. And as he stated, it is most important to get those comments in writing for them to um officially address. We have posted the email address, which is policydraft@Noridian.com, in addition to our website, or our mailing address. This information can also be located on our website under our Policy Development Process. Um as noted, the final LCD will be posted. And as required by CMS, responses to all of our, all of the written comments that we receive will be included in that LCD. That concludes our meeting for today. Thank you again for all of the individuals who were able to get to our Fargo office, those who have attempted to get here. But overall it seems to be a very successful meeting and um we continue to further develop these open meetings and the discussions as we move through the new requirements um from CMS Policy Development. So, we do appreciate your comments, your time and the work that you've put in to helping us develop the policies. Thank you everyone. Safe travels if you are traveling elsewhere.

UNIDENTIFIED
Thank you.

DR. LAURENCE CLARK, MD, FACP
Thanks everybody.