FFRct Carrier Advisory Committee (CAC) Meeting Transcript - June 18, 2019 - JE Part A

Dr. Clark: Hi, this Larry Clark. I'm one of the Noridian medical directors and I'm here with my mentor and friend Dr. Dick Whitten and Krista Babbitt from our staff and we are here to discuss Fractional Flow Reserve CT. I want to open by thanking a whole bunch of people including our medical policy staff Lynda, Linda, Krista, Marie for helping handle all of the paperwork and the conflict of interest statements in the work that had to be done to get a distinguished panel of speakers on. We have people here who are taking time from clinical responsibilities, research responsibilities, and in deference to their time we are going to try and proceed through the discussion through eight, where I want to acknowledge 15 subject matter experts from the Noridian jurisdictions who stepped forward to in today's discussions, in addition to those you [silence] and we're trying to help get other people on to the line right now. So, if you'll bear with me we're going to start the formal discussion in just a minute or two.

I do want to acknowledge some nationally recognized experts: Dr. Dustin Thomas from Texas; Dr. Leslee Shaw who actually is the executive director for the JACC for cardiovascular imaging; and Dr. Christopher Maroules who I met through his article, a number of articles, that he wrote expert analyses for the American College of Cardiology. So, we have a really nice balance between our own jurisdictional experts and some national experts. We have faculty from as diverse institutions, we have a representative from Duke University representing the ACR, we have several major New York Hospital systems represented, so we're looking forward to a robust discussion and we are going to start in about two minutes when everybody gets on.

Our cardiology carrier advisor committee representative, Dr. Malhotra has not been able to get on yet, but I'm going to begin in deference to the time of everybody who is already on the call. Before going to the key questions, I would like to make a couple of comments. I'm going to remind everybody of a little bit of housekeeping. Since the speaker's line is shared, when you are not speaking please be on mute because we will get background discussions. Those of you who have signed up to be our panelists today are on a shared line. When you speak, please just say one or two, you know, who you are, one or two sentences about yourself and any conflicts of interest, and then let's try and get this wrapped up in deference to all the clinicians and people whose academic responsibilities are there. Let's try and get focused on this discussion for 90 minutes. I'm going to open with a paragraph that I think summarized, yes, one other housekeeping item. Don't, please don't put us on hold. If you have to, hang up; this is where the speakers, please hang up and redial, otherwise, we get music in the background.

Here's a paragraph that I think is very important and one of the speakers will definitely recognize this, as he wrote it. "More importantly, such a workup can be the gateway to appropriate revascularization. These functional CT imaging strategies are complementary to CTCA. With the excellent anatomic definition provided by CTCA, one can identify a culprit coronary artery, assess plaque morphology for high-risk features, determine the extent of subclinical atherosclerosis for initiation and intensification of medical therapy and exclude CAD in low to intermediate risk patients with a high negative predictive value. In contrast, functional CT imaging with CT perfusion and FFRct allow one to identify the impact of plaque on blood flow, optimize clinical management, and avoid unnecessary invasive testing, or guide for appropriate revascularizations." The panelist that should really recognize that is Dr. Christopher Maroules, from Virginia Beach. He wrote that in an article about two years ago, "CT Perfusion and FFRct Are Ready For Clinical Use." That was an expert analysis for the Journal of the American College of Cardiology. Dr. Maroules, are you on?

Krista Babbitt: He is, but he has not called in.

Dr. Clark: Okay, he's on but not dialed in. Dr. Shaw I see that you are on and dialed in. She's putting her pin in as well. Dustin, Dr. Dustin Thomas, are you available to respond to that statement and do you think that is germane particularly to the Medicare population?

This is Leslee Shaw. Can you hear me? I can…

Dr. Clark: yes, we can and thank you very much.

Dr. Shaw: Hi, I apologize. I didn't see that audio code. So, the question is I think, so I think that paragraph by Chris really nicely kind of identifies some of the strategies that that and the data that's available. You know particularly. I think with FFRct, well first of all I think to answer your latter question about is it relevant to Medicare. Well, certainly as Medicare is a population that has highly prevalent coronary disease, and so to that extent and revascularization decision-making is quite common in in the Medicare population. I think that the data as Chris and you so nicely stated in the FFRct data is highly concordant with invasive FFR which is, as everybody knows, it's the basis for looking at pressure gradient or pressure loss across the stenosis and looking for lesion specific ischemia, and at the two or three pain trials, the interventional trials, you know support that FFR guided percutaneous coronary intervention, or PCI, results in the marked improvement in outcome and so the correlation with FFRct to invasive FFR are particularly, in that intermediate stenosis, proximal mid and intermediate stenosis, I think is highly valuable to really identify those patients that would benefit from revascularization.

Dr. Clark: Thank you and for, because I know you were just working to get on the line, that was Dr. Leslee Shaw from the Weill Cornell faculty and as an established, nationally established researcher in this field. And do you have any conflicts doctor?

Dr. Shaw: I guess no, I've used FFRct in my NIH work, but I do, I do not have any relationship with the company.

Dr. Clark: Thank you very much can I, I'm gonna trouble you for one more question and then I'm gonna ask if any of our local subject matter experts want to respond to that same question. It's question number two of the key questions, because we always tend to see in these things define intermediate coronary stenosis and Chris Maroules talked about low to intermediate risk patients. I think there's stratification of risk and then there's an anatomic definition. Can you help us understand who should be targeted with this technology, and, and you know, is there some common definition of intermediate coronary stenosis?

Dr. Shaw: Sure, and I just want to make a quick preamble about this. I'm sharing the section, there's the ACC American College of Cardiology, American Heart Association is updating the chest pain guideline. FFRct will be in that chest pain guideline. I'm fairly confident. The guidelines are currently being finalized. I told Dr. Clark that I'm sure a request from this group you could get an early look at that guideline which does deal with the specific question, and generally speaking an intermediate stenosis would be somewhere in there in the 40 to 70 percent range as is noted here. And certainly, it's more often precisely in the proximal, middle part of the coronary artery, less so in the distal part. That's kind of your traditional definition of who would benefit most from, from using FFRct. The inter, if you look at the pretest like, the pretest risk or the low to intermediate risk of coronary disease, that would be something that would happen at the time of initial recommendation to go to CT whether or not they, they, have an appropriate indication based upon risk factors, based upon symptoms, symptoms to typicality, etc. But in terms of FFRct, the this would be purely anatomic criteria. The CTA is performed, and the patient has an intermediate stenosis in that 40 to 70 percent range, and that's where they would be indicated, and that's where the evidence is most supportive.

Dr. Clark: And you feel, again going back to our charge as Medicare medical directors, and understanding we do have a younger population by virtue of disability, but do the same premises apply to our population? There's no way that you would change the grading or evaluation in any way for the more senior population?

Dr. Shaw: No, I don't see that would be necessary. I think the indications for PCI, for coronary revascularization, and understanding whether or not a specific stenosis is ischemic, is in that range and that would be relevant across their age range and and other types of varied populations.

Dr. Clark: Okay. Thank you and I also want to thank you for being kind enough to look at my humble efforts at writing the key questions and your support in developing this. I'm going to ask any of our subject matter experts from JE & JF, does anybody want to add into that discussion at this point? And please just say who you are, and the conflict, and go right into it. Hearing nothing, I, I can see from the computer here, that Dr. Maroules, Dr. Christopher Maroules has been able to activate his PIN and is now online. Let me ask you to handle a couple of comments on the first key question, the reliability of FFR as determined and how does it stack up against the catheterization and pressure wire assessment.

Dr. Maroules: Yeah, it's a great question. So, I have no conflicts, first and foremost. And it's a pleasure to be part of the panel. So, there's been a lot of resources invested in validating CT FFR and there's an abundance of data which you have access to and I think you nicely summarized the document that you sent us, but it's, it's a very high correlation between the two techniques, the non-invasive CT technique and the invasive FFR. That's been demonstrated now in multiple trials and so I think that there's a high, high degree of concordance between the two and that's well validated. Larry can you help me?

Dr. Clark: Yes, you are talking, I think in your paper, which is actually how I came to contact you for this call, and, I thank you, the day you referenced FAME and FAME 2 as actual sort of head to head comparisons that you thought were very significant. Is that right?

Dr. Maroules: Yeah, those don't specifically deal with CT FFR, but it gets to the point of you know, lesion specific ischemia guided revascularization, so that it's kind of a, it leads to sort of a good preamble to understand the value of this type of technique for guiding management for patients with chest pain. But those studies don't specifically deal with CTFFR.

Dr. Clark: Great, thank you and moving on, we'll move on to question three and if you would be kind enough to help here, because I really think this was the thrust of your expert analysis in the JACC, and then again, I'm going to ask our jurisdictional subject matter experts if they have comments. The relative value, what is the relative value of non-invasive stress imaging and FFRct in the assessment of stable ischemic heart disease? And I'm really pleased at a and a fellow internist, Dr. Shonrock from Utah signed on the call. I think this is, and if she wants to join at this point, this is a question that a lot of us have that refer patients. Where is this of value? How does it match up to other functional imaging perfusion studies, etc? Where do you see this as opposed to other non-invasive studies in the evaluation of Medicare patients?

Dr. Maroules: Yeah, I mean, you know I think Dr. Shaw, you know, our past president of FSCCT could probably speak more intelligently than any of us on this subject. She's invested a significant part of her career, in investigating this question. And so I, really the heart of the matter is, you know how do we want to guide management of patients with with stable chest pain, and for what we've learned in, you know the same studies and other large trials, is that you know Anatomy alone isn't sufficient, and you know historically we've referred patients with intermediate stenosis on CT to the cath lab and we've determined that stenosis itself doesn't always correlate with ischemia. Ischemia actually you know we've demonstrated now is, is really a key important feature that should drive management and revascularization and so with the CT FFR we can non-invasively identify lesions that are anatomically suspect and also functionally suspect, and so that's that is sort of the, that is really ultimately what we want to assess. You know which, which lesion is really, do we need to target for revascularization, which will improve outcomes for that patient, and how can we do so you know as efficiently as possible without, you know a large amount of unnecessary downstream testing. So, to get to the heart of specificity and sensitivity, merging those two together with a single non-invasive test.

Dr. Clark: and do you, [another voice] go ahead please.

Dr. Lappe: This is Dr. Donald Lappe. I'm a cardiologist and the senior medical director of the cardiovascular clinical program for Intermountain Healthcare and I work with Dr. Schonrock also. You know I hear this discussion and it certainly relevant when we're talking about value, that to date, the articles and publications in peer review conclude that more definitive studies need to be done to prove its impact on outcomes. It is a interesting technology, assuming that you use CT as a diagnostic tool of managing patients with coronary artery disease and particularly stable ischemic heart disease, but I think there are not tried and trued as we assess the use of Medicare money. I think we have to be circumspect and follow the same standards that we've applied to other modalities that there has to be firm proof that it has benefit and will improve outcomes and lead to improved value of the care that's being delivered and I think to date what I've read and see and experience is that it's, you know, it's a single, it's, it's one vendor proprietary technology that can be added to a CT assuming that you, but there are other modalities, like a cardiac PET CT, that is incredibly accurate since we want to revascularize only significantly hemodynamically, hemodynamically significant lesions and significant coronary arteries or the other standard symptoms driven, but so I I'm not, I remain skeptical from at this stage of its development that it should be covered by CMS for in at this current time without further out, broad outcome, studies.

[Multiple voices]

Dr. Schoepf: From Medical University of South Carolina. I'm a radiologist heading up cardiovascular imaging here. I do have some conflicts, however. With Heartflow, I work with them and another company Lucid imaging, for the record. I just wanted to respond to that comment very specifically. There's one important piece I think, that it's missing from the bibliography, that's a 2019 study published by Driesen in JACC, that specifically tackles that issue of comparison with PETs, because it was just mentioned, and that study actually conclusively shows in a large population that at FFRct outperforms PET among other things. It also out performed SPECT and it outperformed CTA alone obviously, so I would recommend that that is reviewed and included in the bibliography.

Dr. Clark: Hi, next Dr. Ahmad Slim.

Hi, this is Ahmad Slim. I, I don't have any current conflict of interest, but I was involved in the initial application for category three for Heartflow. I just wanted to address some of the issues that were brought up. As far as outcome studies, there are some outcome studies that are published. You can look at the article that was published in Radiology in 2019. That looked at a minor revascularization in patients with a FFRct less than 0.8 and the follow-up was for five years. Or other studies from single centers that went as far as one two three years and I'm happy to share that data with the group. So, there are some outcome studies and us, so when you look at a technology like this, in my perspective, we have to look at it from is the technology safe, is it able to predict outcome, and is the cost effective. And I think we can potentially hit all three aspects of it when we talk about CT FFR. Is it, is it safe? There is data that shows that if you have an FFRct you can risk stratify patients to [phone cut out]

Dr. Clark: Dr. Slim, we just lost you. Could you just repeat those last couple of assertions?

Hello

Dr. Clark: Yes, Dr. Slim we're just some, we're having a little bit of difficulty following you. If you could move to a place or get on a more secure line, because I think your points are really valuable. I'd like to hear them.

Hello? I don't know

[unidentified speaker]: Then may I make a comment in the interim?

Dr. Clark: Sure, absolutely and please identify yourself. We're trying to take notes and, and we're recording this as you know, so please introduce yourself.

Dr. Yucel: Okay, I'll again, I'll yield to Dr. Slim if, when he reappears. I'm doctor Yucel, Y U C E L. I'm at Tufts Medical Center in Boston. Radiology. No conflicts. I would like to give like my perspective from the clinical applications I've used. I'm a been using Coronary CT for a long time and I've recently started using FFR, and I think it's, mm, actually has a major use in specifically in the Medicare population. I'll tell you why. I believe CTA in the younger population is predominantly used, are in my experience, for people with atypical chest pain, many of whom who have no coronary disease. So you know with the coronary CTA can exclude disease very easily in those patients and call it normal and that's a great way to triage people away from cath. I think the older population is, specifically the Medicare population, is more challenging, because they often have more disease whether or not related their symptoms and this is quite problematic and measuring percent stenosis on CT is not an exact science. And there is some, for lack of a better term, you know guesstimation involved, and it's specifically in this population that has underlying disease where the functional information from FFRct is very helpful. We know from the lot of the EDX variants specifically that using CT and this population can actually increase the cath rate because you, we find disease that may or may not be significant and they end up getting cathed and I think this is where FFR is very useful extending the application of coronary CTA into the Medicare age range, without increasing the false positive rate and maintaining a reasonable cath rate.

Sorry, this is Vinay Malhotra. Can I get in?

Dr. Clark: Yes, and please join, join us Dr. Malhotra and help me in keeping this discussion on track. So, thank you for being here and please jump in.

Dr. Malhotra: Apologize. I was on mute for the longest possible time so I'm jumping it now. I've listened to the pros and cons and let me start with the gentleman from Intermountain health. You know I was on your side, I want to say about five six years ago, when the data regarding outcomes rate, regarding large-scale studies, regarding applicability of this technology, was not as robust even though there were single center trials, there were some large center trials, especially the NXT trial which had significant data at the time. However, as Joe Schoepf pointed out, and then as Ahmad pointed out, with the advanced registry significant number of patients, significant follow-up. This technology has now demonstrated where it really falls into play and I agree, you know, the difficulty lies primarily in your Medicare population. I do angiograms and I used to do interventions in the past, I don't do it anymore, but I can tell you this, when you have multiple stenosis, multiple areas, and I'm not talking about acute coronary syndrome, I'm not talking about atypical chest pain where the patient is here to exclude CAD, I'm talking about a patient where your risk factors, you have symptoms and you are trying to figure out which vessel to target and where. I do PETs, I do see CTs, I do SPECTs, I do stress echoes, so I am familiar with all their, all the techniques and their accuracy, sensitivity, specificity, and I've been now in practice for about 19 years. Here's what I think it falls into play. When you look at multiple deviations with multiple areas, the anterior wall or the inferior wall ischemia alone is not going to help you as an interventionalist. When you're trying to figure out which area to focus on and try and help that patient improve symptoms, ahh, we can go into discussions about whether it improves mortality or not, that's the standing argument. I'm going to keep that out of the way, but let's just say which vessel to stent and where to stent, that's where this falls into play very nicely. Whereas, if I just tell my interventionalist it's an inferior ischemia and now I have three stenosis that I'm looking at, at the right coronary artery I have no idea which one of those three is actually the culprit vessel, whether there's a drop in flow, where there's a positive read. I mean when you do IFR or when you do FFR, that's where you try and figure out and that's why you see the use of those techniques have increased in the recent years to try and help the interventionalist figure out all of those three or four lesions in the right coronary artery, I'm just giving an example, which one would be significant and then go ahead and stent that versus putting in a five stent in toward the vessel and hoping that you did the right thing for the patient. So, I think this technique is now, it has proven its value, it's proven its worth, and as Leslee pointed out earlier, 40 to 70 percent is the right lesion or area where you can call it intermediate coronary stenosis. You know we've talked about what's the right test to do in what, what's the right population to do that test for? There are studies which have looked at it, the latest studies looking at this thing in the multi-center trial, PROMISE trial, demonstrated what was better there in exclusion. There's also a trial done called RESCUE trial, it's in publication, it'll come out soon. We looked at intermediate and high-risk patient population and then to try and demonstrate what's more accurate. In a nutshell, I can tell you, if you have disease where you've had some intervention bypass or anything, the imaging modalities like PET CT or SPECT or regular PET will be, will help you in identifying the area better, but if you're trying to come up at a patient who's come in with symptoms and you have multiple 40 to 70% lesions, this is the technology for that because you're not only making the diagnosis, you're helping the patient by getting them guided therapy. That's where I see it.

This is Leslee Shaw. May I comment?

Dr. Clark: Absolutely.

Dr. Shaw: I'm just gonna, I just, so I just, I don't want to see this as a stress imaging or CT kind of argument. I think if a physician is, is comfortable with, with doing one approach from a stress imaging perspective, you know I've done a lot of my career, I did the COURAGE trials, I did the Barry GG trial, I'm one of the PIs for the ongoing ischemia trial. We do this, you know, a lot and it's done a lot. I think doctor Malhotra hit the nail on the head and I just want to reinforce it. First there's eight randomized clinical trials, several of which have shown an improvement in outcome with CT. There are four, at least four, controlled clinical trials showing highly complied degree of concordance between invasive FFR and FFRct and follow-up just in the last 18 months. There are three very, very large registries looking at patient management as Dr. Malhotra said, including the most, the most recent one year results from the advanced registry published by Manish Patel and Jack Imaging. So there's really this compendium of evidence that the critical usage of FFRct is in coronary revascularization decision-making and I think Vinay elucidated to this, if you want to know if a lesion is ischemic that's going to be very different than if there's a general area of the myocardium that's ischemic. So, there is a, there is a difference between myocardial ischemia and lesion specific ischemia and if you're, if you're interested in therapeutic decision-making with regards to revascularization then FFRct is going to be more targeted to the specific and the precise disease in a given patient. That's just my perspective on it.

Dr. Clark: Thank you. We have a one other speaker from the SCCT who recommended Dr. Dustin Thomas who I know may have to leave for a clinical conflict in a little bit. Dr. Thomas are you there and can you weigh in on this issue and then I think we're going to go back to Dr. Lappe in his dissenting position. So, Dustin, are you there?

Dr. Thomas: I am there. Thank you, sir. I was having a hard time getting off mute as well. Dustin Thomas, cardiologist from Texas. I have no conflicts. It's really hard to follow Leslee Shaw but I will say that I completely agree with everything she said. I mean ultimately, you know, getting back to the heart of this, the third question that you've posed to the group which is, is there a value to performing on the basis of imaging in patients with stable ischemia? The bottom line is, is clinically it's yes. I mean patients come to you with symptoms that may or may not be secondary to ischemic heart disease and in our day and age of advanced imaging and, you know litigious society, it's really hard not to try to make a diagnosis. I think from an economics perspective, you know it isn't one of the more common causes for heart, for chest pain symptoms and so I think it, the onus is clearly on the cardiovascular community to make the diagnosis if its present and in my, in my mind CT as Leslee laid out so very nicely with, with the multiple clinical trials, is poised to be at least on par, if not slightly superior to other diagnostic strategies in that regard. I think when it comes to FFRct, really what we're asking as Leslee said is what's the significance of a specific lesion as seen on CT, which in my clinical experience, I think the clinical experience of the group that does a lot of CT, is we're probably talking about 10 to maybe 20% of the total CTs performed in a given lab. You know as I think, it was pressed or somebody earlier mentioned, the vast majority of cardiovascular CTs are going to show no significant disease at all. Ah, 30 to 40 percent of patients in the PROMISE trial and the STODDARD trial had no coronary disease and so, in those patients, you can simply stop right there. But in those very small subsets of patients in which the significance of a specific lesion and the patient symptomatology are unclear FFRct provides a very nice strategy for mitigating unnecessary caths and making clinical decisions about whether to medically treat someone, send someone to the cath lab for a vascularization or prior prevention strategies and the like. So, I think in answer to the question, specific question posed, answer is yes on both accounts. I mean I think it's important to make the diagnosis and then I think it's important to, to use all the technology in our armamentarium to refine our treatment strategies in a patient-centered manner.

Dr. Clark: Thanks, thank you, thank you. We did hear, how can I say, somewhat of a dissenting or questioning voice. I believe it was Dr. Lappe, if I'm pronouncing it correctly, for me.

Dr. Lappe: La-Pay

Dr. Clark: Thanks, please go ahead.

Dr. Clark: And I'd like you, to hear you, respond to this and if anybody else has similar feelings or, or concerns. You know I'm still questioning from the point of view of the referring physician and I think you mentioned Dr. Schonrock is at your facility. Where do we go, where do we start, and what are your feelings about the assertions that you have just heard and along, before I forget, ask Dr. Joseph Schoepf, if I'm pronouncing that correctly, you mentioned a reference. If you could just refer us to that citation, the way that you got in touch with us, I would really appreciate that. Dr. Lappe please go ahead.

Dr. Lappe: Well thanks, and I mean, there's no doubt that, that CTA has give, provides information and the FFRct gives through the proprietary single vendor product gives information, if we're getting a lot of information, are we still need to be humble about how much we do and whether we are doing any good. You know our FACTOR 64 trial from Intermountain was a real eye-opener that we took patients with advanced diabetes but asymptomatic from a atherosclerotic point of view and randomized them to CTA versus standard medical therapy and at the end of the study we had actually improved the treatment of our diabetics, so the difference in outcomes using CTA guided for the silent ischemia potential showed no benefit and, and so this, all this effort and it sounds like we still will be driving more potential utilize stenting without clear, clear outcomes benefit. You know, remember one of the studies showed at most a 70 percent change in decision-making with the addition of FFRct. I think the, you know, from Douglas, that it's not in, the study was not even a tightly controlled observational study, not a randomized trial. The, I think we're just early in the journey of clinical outcomes using a new technology to say that this is, this is worth in Medicare's investment when money is tight. I think I tend to be more conservative and, and careful into how we extend the coverage of Medicare since the money's running out anyway, and you know I think there still is controversy out there over the overall net benefit and outcomes and impact on best practice to the care that's being provided. So it's, it's, you know, so that's a, sorry I dissent.

Dr. Shaw: FACTOR 64 though was in asymptomatic individuals and, and, and, I don't, we're not, we're not talking about using that, any technology on asymptomatic individuals. I just want to make sure I'm following this correctly.

Dr. Lappe: yeah, so the, all I'm saying is, is, the, is I hear you, and yes, it is not meant for asymptomatic, but I'm just saying something that sounds like at that time, that it would, this is eight, ten years ago, that this would be a great use of a technology didn't come forward. Here we have another addition to CTA and some of the studies were done with, you know, the Revolution which not everybody has access to so that may also impact the real, real world experience, so I'm just saying we need to be circumspect and is it ready for primetime is what I'm questioning.

Dr. Shaw: I don't think, I mean the DIAD trial showed similarly that perfusion imaging was, didn't impact on outcome, but I'm just careful that, that we're just not understanding the, the, the magnitude of the evidence here, and as I say this, as somebody who's sharing the HTC guidelines, and I don't have a nickel in this one way or the other, I, I just think that, you know, in those patients that have gone to CT, that have intermediate stenosis and the decision is do you treat them medically or do you make the decision that the lesion is ischemic and is likely to be problematic in terms of increasing major adverse cardiac events, then we know FFRct is going to be, as Dustin very eloquently stated, it's going to be very effective in that category of patients that has an intermediate stenosis. I think the physician dealing with the patient sitting in front of them still has that, you know, option at least, as we do here at Cornell, but the physician still has that option to do stress testing if they'd like, but we're just saying that the FFRct, the CT literature, has changed quite dramatically over the last few years. Just in the last year, we've seen two Apriori analysis from the PROMISE trial which was done across diverse centers, not even remotely all expert centers, in the SCOT-Heart trial, which was done all over Scotland, and many non expert centers, a wide variety of equipment has shown that CT can improve outcomes over and above standard stress testing. I think it's proven itself that it is an option to have for physicians who would like to just know whether the patient has, to give them a diagnosis and then FFRct is an add-on to that in that specific population with an intermediate stenosis. I think the evidence is stronger than, than, than what we're talking about here, at least as I see it, and as somebody who's focused on this over the last 18 months.

[Male voice]: Hi doc. I'll stay weigh in for one second?

[2^nd male voice]: Sure, go ahead.

Dr. Clark: Just please identify yourself so we have it.

OK, Youcell, Yucel

Dr. Clark: Thank you. Please go ahead.

Dr. Yucel: Yeah, so no conflicts. I think we don't want to get, you start about outcomes and all that, you're really kind of talking about two things at once. You're talking about the efficacy of stenting itself versus the modality. I think it gets very complicated when you combine those two things. So, if we were in a world where we weren't stenting anyone and there was no indication for stenting, then there would be no point in looking for stenosis or, maybe they would to look for medical therapy, I don't know, but we live in a world where at least for chronic stable angina or, you know, chronic angina syndrome symptoms, we believe to know, we believe stenting can relieve the symptoms. Let's keep it basic. Not talking about survival or anything like that. So in this situation where you have chronic chest pain and you want to find out if there's a lesion that's stentable, we all agree that stenting can improve chest pain, then CTA is a great option for that. The problem is that we're going to have some small percentage of patients, and I agree it's small as was mentioned earlier, where the FFR can help, and that's where if those are patients who have atherosclerotic disease in this intermediate range, a lot of the patients we scan have normal coronaries or severe disease. They don't really benefit from further investigation but for this intermediate range of disease, these are exactly the patients that we want to predict, if they go to the cath lab, whether they're going to have a hemodynamically significant lesion and where that lesion is. So that's exactly where FFR is helpful and again, I want to add, that's going to be more prevalent problem in the Medicare population than in the younger population. The presence of disease is more common there (inaudible) it's going to be helpful and the distribution of disease is going to be very important in terms of these population studies because the, after the FFR add-on is much going to be helpful, really only in the patients who have disease, so the prevalence of disease and your pop, in your population to getting CTA, is going to be very predictive of the utility of FFR.

This is Dustin Thomas again. No conflicts. Just a hop in, I mean this particular, you know, scenario has been studied and, and I too share Dr. Lappe's concern over cost. I mean I think that's a very important thing that we need to look at in this whole thing, but the bottom line is, is that, you know, in the PLATFORM trial where they looked at patients, they were already going to go to the cath lab, and they added CT with FFR into the mix versus usual care, they showed a 60% reduction in the need for invasive coronary angiography to begin with. So cath is significantly more expensive than FFRct and so if the goal is, is, you know, let's just say the holding goal is to reduce cost, and I think adding FFRct to the mix has this, it has the potential to do that and has been shown in populations with a, I believe it was about a 30% reduction in the cost, in the invasive group. From a patient specific perspective, I mean, you know, if you're talking about patients that have to schedule around, you know, these, these kinds of tests and layered testing and things like that, I mean, if I were the patient who was undergoing a chest pain evaluation and I could, I could be completely cleared of any significant coronary disease or need for further testing by having one CTA and having that scan sent for analysis without having to lift a finger, and have definitive answers to, to my coronary anatomy and these hemodynamically and the hemodynamic significance of that anatomy without having to, you know, asked off work multiple times and, and arrange for childcare and things like that to come along with, with frequent doctor visits, then I think I would take that for sure, so I think, you know, I think the, the perspective about cost is a good one, but I think that there is data on the books that have, have put to rest some of those concerns about the ability of FFRct to increase cost when you're talking about such a significant reduction in the need per, to go to the cath lab.

Hey this is Joe Schoepf again. Can I stick a word in here to make this a little bit more definite?

Dr.Clark: Please

Dr. Schoepf: Thank you. So just uh, about the PLATFORM trial, and ah the cost savings that are associated was this, so the ah, to be more specific to cost savings of 23% at 90 days and 26% at 12 months, to keep going up with time, if you compare invasive testing and if you compare FFRct so that, that it demonstrates a clear cut cost saving far as they are concerned. A couple of times also, ah, the advance registry was mentioned, that is also document, actually sent your way for review, because it was not included in your bibliography. And if I may quote the conclusions there says, like a, in a population, of a, in excess of 5,000 patients, the one-year outcomes from the advances of RCT registry show low rates of events in all patients with less revascularization, a trend towards lower may significantly lower cardiovascular death, or an eye on patients who never made it to RCT compared to patients with abnormal adversity values. So, I think the statement that we don't really have evidence, as far as the outcomes are concerned, can no longer stand so 2019 very recent document but as I said in a very sizable population of patients in excess of 5,000 that clearly shows the benefits there. And if I, if you look at the practice of cardiology, I think currently cardiologists tend to do like one non-invasive test and one non-invasive test only, so if the hopping basically from CT to SPECT or PET, or in between non-invasive modalities to stress echo or anything like, that it's kind of over simply because of efforts at cost saving. So if you're basically looking for non inva, one non-invasive test, to give you all the answers, I think I would put my money on FFRct simply for the reasons that Chris Maroules put into words here, gives us that crucial combination of morphology of structure, access to high risk black features, and things like that, in combination with the functional aspect for which you traditionally needed SPECT or things like that, so if you're looking for a chance for cost saving, I think that would be a very good strategy.

Dr. Slim: This is Ahmad Slim. Can you hear me again?

Dr. Clark: Yes. Please.

Dr. Slim: Hello, yes, all the points that were brought up were amazing and the one thing that I just wanted to highlight is, let's just think of the patient as well, we're talking about an anatomic test and we're talking about no matter how accurate PET or SPECT are, further radiation to the patient, an inconvenience and associated complication, versus applying the same data that were acquired to get hemodynamic significant that is superior to existing data, so if we just think from the patient perspective and radiation, and it was brought up earlier about downstream over utilization testing. This is the ideal test to avoid that. This is the ideal test has been shown over and over multiple trials, not only to decrease further testing, but just to even decrease the ITA, the invasive angiography, and varies from whichever article you look at from 40 to 60%. So there is cost saving as significant to the patient because you're not exposing up to further radiation. They're risk stratified the intermediate lesion.

Dr. Clark: Doctor Slim and Dr. Schoepf, I'm going to ask, I think both of you in some ways have alluded to the PLATFORM trial and my understanding from trying to read these articles, and again this bibliography was assembled by me without the benefit of all of your subject matter expertise. There have been a couple of recent articles mentioned, I'm going to ask you to send them to me for inclusion in the development. I think, you know, I've seen Dr. Whitten kind of nodding. I think we are going to go ahead with some type of coverage policy following this discussion, so I would like those articles. Now PLATFORM, my understanding is that a hundred and seventeen patients in the initial cohort had their coronary angiograms canceled on the basis of the study, and the study went out to one year without any, I think determines major adverse coronary events. In other words, they all did well. How about after that one year? Was that trial continued or do we have anything similar that talks about divergence in populations, after the canceling of the angiography, down the road, do any of these things go out longer.

[Multiple voices]: I think there's couple of studies. Are we talking about outcome?

Dr. Clark: I'm sorry, one at a time. Who was that? Was that doctor Slim?

No, I was just clarifying the question. Are we talking about the safety beyond…

Dr. Clark: I'm talking about that there seems to be an assertion made on the basis of PLATFORM, that there is a major subset of patients that, that are detected by FFRct where the invasive coronary angiography can be canceled. And I'm just asking, does that get followed out for longer than a year in any of these trials, and do we know that really it is safe on the basis of this study to cancel coronary angiography?

Dr. Schoepf: There is a single center study that was done in our house Hospital experience and they looked at an average. It was a two-year medium follow up, with some exceeding three years, and almost 3600 patients and not only did they look at all cause mortality, none fail MI hospitalization, they also looked on unplanned revascularization and caths and none of, of the composites increase in the population that had an FFRct that was over 0.8. So, by excluding it even with that follow-up in a single center there was no unplanned revascularization ICA. So, it is, but that study did not look specifically at cost-effectiveness, just like the PLATFORM did by a reduction of 26% and, by the way, that 26% was accounting for the cost of the FFRct, so it's safe to assume, but it was not analyzed from that perspective. But if, did it question itself, is a reduction in ICA continued, at least from that single center, we can say so.

Dr. Clark: Thank you. Who was that

Dr. Schoepf: This is Dr. Schoepf again here in South Carolina. Let me just add that, actually the outcomes of the NXT trial that's a part of your bibliography, which was one of the original trials establishing accuracy, it does have three to five years outcome and there was an extremely low risk of those folks that any major adverse cardiac events give an FFRct value of greater than eighty, meaning like a normal value. So normal FFRct value in that extreme population, near the predictive value to exclude major event holds up to three to five years after the index test.

Dr. Clark: Thank you. Thank you. All right that is, go ahead, someone else?

Dr. Schonrock: Hi, yeah, this is Krista Schonrock. I'm with an internist with Intermountain and I'm no conflict. I honestly, as I looked through the studies and a few others and listened to this wonderful discussion, it's nice for a patient to have an option as well. Certainly, in our Medicare population, stress test, certainly the treadmill, is often not possible and chemical tests are extremely uncomfortable. So when there's other options to offer patients who are having chest pain in this intermediate risk category it's always a nice thing to have. I get a little nervous when there's a single vendor but we certainly, you know, Medicare covers there's a lot of things that have a single vendor if you look at the genetic coverage, so this wouldn't be new in that realm anyway. I was just wonderin' and I don't know if anybody has any thoughts, if we need to address anywhere of recurrence or frequency of testing?

Dr. Clark: That's a great question?

Let's go to some of our subject matter experts to step up to that one.

Dr. Shaw: This, I do, I do, want to comment just quickly. This is Leslee Shaw again, no conflicts. About the single vendor, the single vendor issue is there, there's a lot of similar applications and development now. If we were having this call a few years from now, we wouldn't just be talking about one vendor. Just, just FYI. So one vendor, all, makes us all nervous, in particular, you know, when we're trying to do what's right for our patients, right? But, I do think that the indication for serial or a second CT is, there's no indication for serial evaluation using FFRct a second test. The only indication for a follow-up CT would be if the patient has failed medical therapy, if there's recurrence or worsening symptoms similar to what you would say for any type of reimaging procedure. There was a concern that the patient's having breakthrough symptoms or what, but there yet they're still stable and so they're not unstable, but there's really no indication for do this now, and they do it 90 days from now.

[Male voice]: This is Wright

[Second male voice]: This is doctor Yucell again. I think the question about repeat imaging comes from a lot of different applications, where in radiology we are starting to do six month follow-up, 12-month follow-up, etc, etc, mainly for oncological applications. I agree, I don't see that that's really an issue here, only if there's a substantive change in symptoms would there be any need for further imaging. There's no, I don't see any, there's never been any established role for a quote-unquote follow-up in any kind of routine basis in this disease.

Pam Noack: This is Pamela Noack, I'm from Northwell Health. I work with Dr. Michael Poon. I'm an economist, he's a cardiologist and cardiac imager. We have done and I have, we had a, we started a investigator-initiated study using FFRct so that what might be considered a conflict, but we enrolled in that trial more than 500 patients and at the end of the trial we decided as an institution to accept that FFRct is part of our standard of care, so we've now performed this specific procedure on more than 500 cases and our findings have been that it has consistently reduced our utilization of cardiac diagnostic caths by 25%, that we have, we've been able to follow all the patients safely, we've had no unexpected MACE events and that we, we have I believe two patients so far that I'm aware of, that subsequently after having a negative FFRct within the 3-year follow-up time for these patients wound up having an intervention but their condition worsened on CCTA exam as well as FFRct so we attribute that to just natural disease progression. So we've been, from economically and medically both, we've been very pleased with the, the results of adopting this as standard of care practice. We've done more than 500 FFRct's and we're continuing to do this as part of our routine standard of care at Lenox Hill Hospital.

Dr. Clark: Dr. Noack, I want to thank Northwell for your participation in this call, and while we as Medicare medical directors are not specifically charged, or in some ways they're supposed to be cost agnostic, you do bring a different perspective of, to, to reviewing the care of the patient that we intend to follow up on. So, so thank you for being on this, on this call and your support of it. I also want to thank you Dr. Schonrock for sort of the, the internist questioning or troublemaking on the call and, and I do appreciate that. While we have all of our national and regional subject matter experts on the call, I'd like to go to question seven and eight of our key questions, because I think one of them I can blame on Dr. Oakes for getting me in trouble for asking it. Number seven was a question about risk assessment factoring into the ordering. In other words, stratifying a patient by risk as opposed to anatomic criteria, and the eighth question is really the tough one as we look at it from the Medicare perspective. The clinical utility of ordering this test on an asymptomatic patient with risk factors. That's really sort of heading towards the questions of screening of the asymptomatic Patient. The other question that we, we have seen some claims come in for patients who have a coronary calcifications noted. My understanding is this study is not so good in patients with coronary calcification, but we are looking at the potential application to asymptomatic patients, that's a difficult one for us to deal with, for some statutory reasons. I'd like to hear your opinions while you're all on and then the lastly, I do want to go back to our co-facilitator Dr. Malhotra. He used the term atypical chest pain, something that we're all used to using. How does that fit into, you know, is this stable chest pain? How do we deal with the term where, where do we put atypical chest pain? So, I threw out a bunch of questions but we have 27 minutes left. I like our experts to be on along with our regional subject matter experts, so please can anybody help with those questions?

Dr. Yucell, I'll just leap right in if that's okay? Um, on number seven, I don't believe risk factor assessment should play a role, because what drives FFRct asks a very straightforward question. The lesion on CT, an anatomic lesion on CT, is that lesion hemodynamically significant or not. It's a very simple question and a very straightforward answer. And so, once you've done, so, you talking about a patient now for whatever reason, they've gotten a CTA, so that's a different debate, and this is an add-on to a CT that's been obtained. So clearly, risk factors and all that should play a role in whether you get a CTA, but once you've got it then this FFR asks and answers a very straightforward question.

This is Dustin Thomas.

Dr. Yucell: I would defer to the cardiologist. I mean, is there any role, again, you're trying to identify these people should asymptomatic patients, should they be getting a CTA at all. That's really the issue. If they're good, that's kind of your getting it to kind of get plaque burden or something, then probably not a whole lot of role for FFR, but the role of, but the role of atherosclerosis imaging beyond coronary calcium in asymptomatic patients is very unclear because the treatment that that's going to, who's going to stent these patients? That's asking a question, the answer to the question you're asking and getting an answer to is, should a lesion be stented? But if it's a patient situation does not permit, that does not, does not say you should stent, then why would you even ask that question? Oh, that gets to the issue of stenting in asymptomatic patients which is a whole different debate.

Dr. Clark: Thank you.

This is Dr. Thomas from Texas.

Dr. Clark: I thought. Go ahead. Please, doctor.

Dr. Thomas: Yeah, yeah, just to weigh in on the question 7 that you alluded to. You know really when you talk about risk factors you're trying to basically, without looking under the hood predict who's going to have the disease state and ultimately once you perform the coronary CTA, the risk factors become unimportant because you've made the diagnosis of whether that disease states present or not. And then really, when it comes to, to the question in hand today is now that you have a patient with coronary artery disease, diagnosed by coronary CTA which is, is currently the, the best test for doing that, is, is the, is the disease that you're seeing on that scan hemodynamically significant or not? Does it warrant escalation and medical therapy or appropriate vascularization? All the questions we've already talked about, it, so, to me the answer number seven is clear. That the performance of FFRct should be based solely on the anatomy seen on the CTA that's ordered for whatever reason, as alluded to by the previous speaker. With respect to the asymptomatic patients, I think that's a little certainly a little bit more difficult. Obviously, there's really, really robust data for calcium scoring as part of a risk stratification for patients that are asymptomatic. As far as adding angiography to that mix, in my review of the current literature, there's obviously very limited data on that effect and obviously, as alluded to by one of our, one of the panelists, with respect to FACTOR 64, which is probably the largest prospective trial looking at this specific question, there was no difference in outcomes by doing that, so, but I would certainly defer to the rest of the group for the discussion on that.

Dr. Clark: You know before I think I heard one of our regional experts, Dr. Richard Wright introduce himself and then cut off. Dr. Wright do you have any comments for us. [Silence] Maybe he had to drop off. Anybody else on that…

Dr. Malhotra: This is Vinay. Larry, let me jump into the atypical chest pain population. Yeah, since you eluded to that. Yeah. I mean I have no conflict. Number seven.  A lot of background disturbance. Anyway, number seven. I agree with the discussions that we've had from the last two speakers. I think the indication should be for coronary CTA if there is, or any other modality for that matter, and then after that, once you've identified the lesion to understand the significance of lesion, if there is warranty to do the FFRct, we should do it. I agree with that. Now asymptomatic individual, I think is a big deal because it goes into screening, it goes into completely different world, that not much is there in terms of revascularization in these patients in terms of outcomes, and I agree with the data that was published in FACTOR 64 and other studies that have been alluded to. I think what it comes down to is a very key factor. We know greater than 25 percent of people who walk in with chest pain to the ER have atypical chest pain. They do not have typical characteristics. They may have pleuritic pain, they may have epigastric discomfort which is non exertional, and these patients then go on to have an MI down the line and that has been documented in ER studies. So, I think that patient population, where you have significant risk factors, you have an atypical presentation. Let's start with CT, I'm not going to go into FFRct. I think CT can help you along with other modalities to try and figure out what is significant. And, I think in all the discussions that I've heard today, let's not forget we need to be careful of what is local expertise. If all you have is a hammer in Yakima, that's all you can use. You may talk about PET, CT, SPECT.  You may talk about everything out there, but that's all that you have, that's what I think you would use because the person on that side is comfortable using it, but that's the patient population that I know I put this in, a typical patient with atypical chest pain. I think this can really help, because once you identify that, as the NXT study is going to show, as it's been published as long-term data, as the imaging has demonstrated, you will prevent invasive management in these patients if we can demonstrate that they may have lesions which you can medically manage. and not take them safely for one to three years to the cath lab. unless it is progression of disease from other reasons, other factors. So, I think that to me, it comes into play if you have an atypical presentation. That's where I think there will be some role in it. Otherwise, for an asymptomatic individual, I agree. Where I train in University of Illinois, we did a huge study initially for calcium score and then after that the MESA trial demonstrated its utility. So, the calcium score can deal with that. Larry, I think you alluded to a question which I don't think anyone has answered and that is the limitation of this technique in presence of heavy calcification. And I think, Leslee, do you want to take that or Dustin?

Dr. Shaw: I can chime in and quickly, Leslee Shaw again, no conflicts. You know it's our experience that it's got to be ex, there's a huge difference than, don't you think in terms of a lot of calcium and just a little calcium and [Yup] I think this technology, it can be challenging when there's extensive calcium, but in our experience, often times, you know, if, if this is a dynamic measurement up and down the artery and so, you know, we can often do, you know, look away from the calcium and still get a reasonable measure but that's our experience. But it would have to be pretty extensive coronary calcium, that would be our experience at Cornell. That, that was the only challenge. If it's got a very, very, very, large extensive burden of calcium. Many, many of these patients, most of these patients, will have some calcified plaque in this 40 to 70% range. Virtually, almost all of them, so I don't want to just say any calcium negates the use of FFRct. It's got to be very, very extensive and those patients are very few and far between.

[multiple voices]

Dr. Schoepf: Actual data, if you look at, this Joe Schoepf here, there's data published on the influence of calcium on the accuracy of the FFRct again in the sub study of the NXT trial. It was published in 2016 in JACC Imaging. That actually did not find any differences in the validity of the test between the low and high quartiles of coronary calcium scores, so I would agree with Leslee that if you really have an exceedingly high amount of  coronary calcium, it's probably going to get more difficult, but the data in a larger patient population actually shows that there is a very little, if any, influence between patients with very high and very low calcium scores in the accuracy of their tests. Did I see a published evidence on this? I can send it over as well.

Pam Noack: This is Pam Noack again from Northwell. We have 83 patients in our investigator-initiated clinical trial that had calcium scores of more than 40%. We compared the CCTA reading alone and I had a specificity of 0.51 and we had with, with added FFRct, the specificity went up to 0.74. This was a significant difference so I, I would say that it wasn't as, as perfect as, as FFRct without any calcium, but it certainly increased the performance of, of the CCTA alone. The other comment that I think is really important, that I think I need to make, is, I wanted to draw the group's attention to the SCOT-Heart, SCOT-Heart trial, which documented that there could be an improvement in a reduction in MACE events and fatal MI over a five-year period, if CCTA is used as the first test for stable heart disease, and this has changed the, the NICE criteria for CCTA. They now, and that's the criteria that is used in England, they now recognize CCTA is the best first test for evaluating obstructive heart disease. So, I think this is really important and the reason for this, this prevention of adverse events appears to be that patients who have been diagnosed with a CCTA and can actually see that, yes, you do have non-obstructive disease, instead of going on and living the way that they did before, have actually gone and changed their lifestyle and that has led to fewer downstream adverse events and better optimization of management, which would also be economically desirable in terms of looking at future utilization in the healthcare system.

Dr. Clark: Let me ask. [voice interrupting] Dustin, I just want to get a question or thought in here. [Sure] Somewhere in there I think I included Asher and Singhai, which was a summary of the UK experience. But, and something from NICE in the suggested reading, but those articles may be a couple of years old. If there's anything more recent on the NICE in UK experience, could you send them along please, and then I just want to do again, we may have lost Dr. Wright on the call trying to get in, so if he's on please, I just want to let him know he's in the queue and Jeff Rubin from Duke University representing the ACC came in and we've got about 15 minutes left. There's, there's one other thing that I would like to do. I would like someone to touch on the physician work component. [and you] Ok, who's on?

[unidentified] Larry, I think I'm on to the stress test, because he took that exact point to the CPT panel.

Dr. Clark: Doctor Wright is trying to get in. [silence] Dr. Wright we're holding for you [silence] Dr. Ruben do you have anything while we're working with Dr. Wright.

Dr. Rubin: I think all the comments have been excellent and comprehensive. I really, I don't, don't have anything. I don't have anything. Oh, I think Dr. Wright is trying to get in.  I think Dr. Wright's microphone is having trouble.

Dr. Clark: Yeah, I think that's a nice way to put it. Dr. Ruben. You have anything to add on the base of the ACC? At the conclusion, we're going to tell you what the next steps are in this process. Dr. Malhotra, anything, in other words you're saying the very issue of the physician work in the service is already being addressed?

Dr. Malhotra: I think so, and this is what Ahmad addressed at the CPT panel to get the gaps redrawn, so I think he should chime in on what is the exact position work involved because I don't want to duplicate that, or have anyone else, you know, talk about it, because you've done that specific vignette and everything.

Dr. Clark: If he's on, Ahmad, please go ahead, and if not, I would like to see the vignette and discuss exactly what is being said at the AMA.

[unidentified speaker]: I'm showing him as offline right now, Larry.

Dr. Clark: Okay, not a problem. Thank you.

[unidentified speaker]: I can have him send it to you, I can have [Sure] Yep.

Dr. Rubin: So, this is, this is Geoffrey Rubin. I just want to clarify that it's the ACR that I am a subject matter expert on behalf of, not the ACC. And I also want to apologize for joining the call late. I was reading coronary CTAs in clinic and just got in. I hope that question 4 has been adequately addressed. If it has I certainly wouldn't intend to revisit it.

Dr. Clark: No, please go ahead.

Dr. Rubin: Okay. I just, I wanted to make the comment when I saw the suggestion that there would be a BMI threshold where FFRct is of limited value that I, I don't agree with that specific observation or suggestion. There have been trials that have a BMI threshold as a part of recruitment criteria and that makes a lot of sense, but in our practice at Duke we have a number of patients with BMI values greater than 35 who have been successfully analyzed with CT, with FFRct, and I think that in many respects we're seeing gradual improvements in the CT scanners themselves that allow us to get high quality imaging in larger patients. And so, I just wanted to, to make that point and to not leave the impression with anybody that we should consider that some patients may be too large. There's probably a limit, you know, when we get up to BMI is in the 40s and higher, but to establish an absolute limit, I think is particularly challenging when not considering the availability of some of the most powerful scanners.

Dr. Clark: Thank you. So, the Duke experience essentially suggests that that is a false or unnecessary limitation. That you are routinely handling patients with BMI's greater than 35 and, and handling it well, and more.

Dr. Rubin: Yes, that's correct, but I would not say that there aren't patients, we do encounter patients who are too large, and they are patients that are in the 50s and 60s of BMI, so, so it, you know there are limits, but I would definitely state that at least for our population many folks with BMI's greater than 35 imaged well with FFRct.

Pam Noack: This is Pam Noack. We have the same experience at Northwell. We've scan about 2500 patients annually. We don't find that BMI greater than 35 is, is a, is a problem. We do, maybe, have some, obviously, that may be not diagnostic but we, we find that we're generally able to handle these well and we don't have a fancy scanner.

Dr. Thomas: This is Dr. Thomas in Texas where the vast majority of my population have BMI over 35 and we, we don't, we don't have any issues. I mean certainly there's, there's some, there's some specific things that need to be done at the scanner to optimize image quality, but as it pertains to FFRct, ultimately if the, if the CT scan is of high enough quality then the FFRct is capable of performing the analysis with which you're being at, you're asking it to do. And so, you know, when it comes to the clinical trials that were performed with FFRct, the limitations of having BMI's less than 35 was most likely just to improve the number of patients in which the analysis could actually be performed and that probably had very little to do with whether or not the FFRct technology itself was applicable above or below that BMI. And so, in our experience, you know, BMI's over 35 is not for preclusive in any way and, you know, certainly as Dr. Ruben has alluded to you know when you get up to the mid-40s certainly it's, it's, it's hard to, to up the radiation dose enough to, to get significant photons through, through the body at that point so image quality is degraded to the point where FFRct analysis would be, would not be useful but, but the analysis of the CT itself maybe degraded at that point in time as well, so, so certainly any, any patient parameters in which image quality, you can get high quality images, should all be good for FFRct.

Dr. Clark: Dr. Thomas, you were trying to make a point earlier? Is there anything else you want to add? We're about seven, eight minutes before we wrap up.

Dr. Thomas: No. I think, I think it's all been very eloquently stated by, by many of the panelists and I really thank the group for their time and for being involved with this.

Dr. Clark: But, yeah. I think it's been a great effort and we are really appreciative of it. One of the things I want to ask while we have a forum here is, is there a key question that we did not ask? [silence] Alright then, we'll take silence as we've pretty much covered. I am sort of convening here with Dr. Whitten and I think, as I said earlier, we are going to take on a policy initiative, and I think we now owe you an explanation, in the new process what happens next. Unlike, uh, in the new program integrity manual, the way the way it works from here is instead of coming to you at the CAC with a draft, as we would have in the past, today begins the deliberations. We have reviewed the evidence, we're asking you for additional evidence if the bibliography is not timely, but basically the same subject matter so we will add to this, if there is anything that has been not added or is more timely. We will now on the basis of the discussions, and we will definitely review the recordings. There was an awful lot that was said today there was really quality. What we will do is put together a draft coverage policy. We'll have an open public meeting, probably around October. The proprietary interest any stakeholders, patients, anybody who is interested, impacted affected, does business in our jurisdictions, etc, will be given an opportunity to talk. After that, we will put out a final policy or final draft, that will be first at CMS and then will be put out in a notice period of 45 days before implementation. So, there the period for you to put it in, submit, written comments begins now. We would appreciate anything that you felt, anybody like, I apologize Dr. Wright had a hard time getting in, anybody who felt they did not get comments and today, we would gladly take them in writing and we look forward to talking with you, yet our email is policy, p-o-l-i-c-y, draft, that's one word, all lowercase, policydraft at Noridian dot, n-o-r-i-d-i-a-n, Noridian.com. We look forward to hearing from you and thank you all for taking this effort so seriously and putting a lot of work in, and have a good rest of your day.

Hi, this is Mark [unclear] California.

Dr. Clark: Yes?

Before you sign off I want to ask, these eight questions that we were discussing today, you expect the CAC members were not SMEs to be sending answers to these, were, were these meant for discussion today only?

Dr. Clark: These were meant for discussion today, but they are certainly, I would hope you agree, they're germane to our policy development. So, if you have other people in your jurisdiction, any other people in your society, anybody else who wants to submit answers to these questions, or amplify the questions, please just go ahead and send them in to the email that I just gave you. [ok]

Dr. Malhotra: And Larry I've asked Ahmad to send in the physician work and the vignette that he submitted to the CPT file and has discussed with AMA.

Dr. Clark: I'll talk to you about that later. Yeah, we're not overlooking that. And also, I appreciate Dr. Shaw's heads-up that there is actually a major trial of guidelines coming out and we will obviously try and see what we can of that. So, thank you everybody. We really appreciate your effort.

Thank you.