Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease Open Public Meeting - May 20, 2020 - JF Part B

Jocelyn Fernandez:
Good afternoon, and welcome members of the public to the open meeting for the proposed LCD Non-Invasive Fractional Flow Reserve for Stable Ischemic Heart Disease LCD number DL38613 for Jurisdiction E and DL38615 for Jurisdiction F. The meeting will be recorded. The audio recording and written transcript will be posted on our website. All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered commenters will be allowed to comment during today’s meeting.

For our commenters:

Each of you are being allotted 10 minutes to make comments. Your line will be opened when it is your turn to speak. Your line will be opened when it is your turn to speak. Make sure you are not on mute within your system or we will not be able to hear your comments. You should be prepared to begin your comments immediately when called upon and will hear the moderator’s voice when one-minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information in your verbal comments. We ask that any comments made today also be submitted in writing. While only registered speakers will be commenting today, anyone in attendance may submit written comments. I will now turn this meeting over to Dr. Lawrence Clark for an overview of the proposed LCD.

Dr. Larry Clark:
Hi, this is Dr. Larry Clark. Can you hear me well? Jocelyn you hear me, okay?

Jocelyn Fernandez:
I can, loud and clear.

Dr. Larry Clark:
Thank you. Today and I am going to start with a brief apology to Doctors Rodgers and Brown from HeartFlow. They were kind enough to do this once before with weather impact and now with pandemic change, but they have been gracious enough to represent material, there really has not been any significant change from our previous policy with the exception of removal of one inadvertently retained bullet point about contrast which was not relevant to the policy. What brings us together today is the fact that a CMD Workgroup looking at a potential collaborative policy, looked at the Noridian draft and expressed an interest in hearing a review of the discussion and a republication of this policy as a potential collaborative policy. So, there are and I've just been going through the roster. I thank the representatives of the other A/B MAC contractors that have joined us today. We are talking about, you know, this concept of computer derived fluid dynamic modeling as opposed to previously performed CTA and a derivation and depiction of coronary flow. So, I don't want to take any more time from our presenters so Jocelyn, I believe the first presenters are going to be Doctors Rodgers and Brown from HeartFlow. Is that correct?

Jocelyn Fernandez:
That is correct.

Dr. Larry Clark:
Okay, Dr. Rodgers. Thank you for your efforts here and take it away and we'll follow along with your slides.

Dr. Campbell Rodgers:
Great. Thank you, Dr. Clark and Jocelyn can you confirm that you can hear me okay?

Jocelyn Fernandez:
I can hear you loud and clear, Dr. Rodgers.

Dr. Campbell Rodgers:
Great as Dr. Clark said we're eager to participate in this Open Meeting. We're very grateful for the opportunity. I have a series of slides to walk through and I'll do it as efficiently as I can and then turn it over to the other speakers. I would highlight that as per the prior meeting, this presentation is not focused on the clinical value proposition, which underlies our technology that is widely published. More it focuses on some specific aspects of the draft coverage determination, which we thought would bear discussion in a public forum. So, with that the outline will be a discussion of the exclusions which are listed, discussion of the indications which are listed, and then a brief discussion of the ICD-10 code which is listed in the draft publication.

Go to the next slide please. By way of introduction the pathway you see laid out here is the pathway being discussed today. It is focused as you see in the upper left on symptomatic patients, stable patients whose symptoms are suggestive of coronary disease and in whom a test is indicated. In this pathway of coronary CT is performed and then in some patients where you see the green circle, there is need for additional test information and that is the pathway which leads to the HeartFlow FFRCT analysis, the indications and discussion today will focus on which patients belong in this green circle.

Go to the next slide, please. The draft list of exclusions is listed here. I'm not going to review them on this slide because each appears on subsequent slides with commentary. Before I go through these draft exclusions. I would like to mention two additional exclusions that we believe should be listed in the draft coverage determination. So, if you could go to the next slide, please.

These additional exclusions are as follows. Number one, to exclude patients from that green circle from HeartFlow analysis who have had myocardial infarctions in the 30 days prior to the coronary CTA being performed. This would be in keeping with the ways in which our clinical studies have been performed. We recommend adding this exclusion. Second, we recommend adding an exclusion for patients who have coronary stents and I've listed the specific aspects as this is to be consistent with our FDA clearance. The specific instances in which coronary stents are excluded. So, we would recommend adding this as well as an additional exclusion to the local coverage determination.

If you go to the next slide, please. Now to address the current exclusions, which are listed in the draft. The first is there is an exclusion for prior placement of Venus graphs in coronary bypass surgery. We believe that should be changed to include all prior coronary bypass graft surgery not just Venus grafts. In other words, patients who have had arterial grafts likewise should be excluded from the HeartFlow FFRCT analysis.

The next is patients who have suspicion of acute coronary syndrome. There is some nuance to this, and we recommend being clear that the patients who are to be excluded are those in whom acute myocardial infarction or unstable angina has not been ruled out. Those patients should be excluded and if there are questions, we can certainly talk in more detail about this. The specific language here is actually taken from the Palmetto draft LCD. The number is listed which has been published. So, we simply cribbed that language and think it makes sense here in lieu of what is currently in the new Noridian draft LCD. The next slide, please.

The next listed exclusion is patients with severe with known severe aortic stenosis. We believe this exclusion should be removed from the LCD the way our methodology works is to take into account left ventricular mass as derived from the coronary CT and as brought in to the analysis patients with aortic stenosis have increased left ventricular mass because of the hypertrophy induced by the aortic valve narrowing that factor is taken into account in our analysis. So as long as these patients are stable and symptomatic, they would be analyzeable and we suggest should not be excluded from this LCD.

Go to the next slide, please. The next is a set of three listed here obesity prior prosthetic heart valves and extensive coronary calcification all listed as draft exclusions. These will all be addressed as a group and the next couple of slides because they all fit within the same paradigm. If you go to the next slide, please. Those three listed exclusions are related to concerns about the quality of CT image data, which can be acquired in such patients based on obesity calcification etc. The way that our process FDA-cleared process works is that CT images when they first come into HeartFlow are assessed for data quality. They go through an inspection. The details are listed here of the attributes which are assessed for each scan.

There is a scoring method which is performed by trained analysts and if the study fails image quality the bottom two bullet points on this slide, HeartFlow does not complete the analysis. It does not charge for the cases and it provides an explanation for each failed case to the site as well as training to help improve image quality for future studies. Go to the next slide, please.

This simply shows three images from coronary CT angiograms which illustrate across the spectrum from excellent to satisfactory to poor image quality just as an example of what analysts, our analysts see as they undertake this grading. I would mention that we have approximately 90 percent acceptance rate across the world and in the U.S. for real world, real world experience based on our commercial data. This has been published in the references at the bottom of this slide. Go to the next slide, please.

This is another example clearly even to a lay person not experienced in CT image analysis demonstrates poor image quality on the left where it's really hard to make out where the vessel is where the Lumen is and good image quality on the right.

Go to the next slide, please. In terms of calcium specifically, which was one of this set of three exclusions. There is published data. The reference is on this slide that four scans which passed our image quality inspection. Our accuracy against invasive FFR is the gold standard is preserved across all calcium score values.

Go to the next slide, please.

So, to return to this set of three we recommend that all three be removed and the reason is if the CT image quality is unacceptable, there will be feedback provided. There is no FFRCT processing that takes place and there is no charge.

You can go to the next slide, please.

The final section I would like to speak about is the coronary disease as on seen on the CTA which may lead to the need or the consideration of a HeartFlow analysis. There are two specific areas one is exclusion number six, which excludes patients with known three vessel disease. The next is a series of indications, which I won't read through which talk about specifics vessels and specific degrees of stenosis depending on the vessel, which suggests the need for additional physiology may be indicated. Go to the next slide, please.

And for the interest of time, I'm going to ask you please to forward to the very next slide, which is a table of numbers. Thank you. From our data consistent with everything that's known about invasive FFR as well. If one looks across degrees of stenosis, that's the 30, 50, 50, 70 and so forth at the top, or the specific coronary vessel those are the three distributions on the left. The disconnect between the FFR value being normal or abnormal and the level of stenosis is by no means constrained only to the mid-range of 50 to 70%. So, for example in 70 to 90% stenosis where one might think the FFR would not be of incremental value looking across all vessels 25%, one in four of those vessels are actually not physiologically significantly FFR is normal. In the 30 to 50% range conversely where one might think those are not abnormal by a stenosis 31% of patients have actually abnormal FFR so to restrict access only to that middle range or only to certain vessels is at odds with the clinical value. You can jump forward one slide, please.

I'll highlight the bottom of this slide go forward go backwards, please. Six in the 70 to 90% range in a large study of over 1,500 patients with this stenosis 62% had a different management plan after FFR than they would have before. Now finally, please go forward two slides. One more, forward, one more forward. Thank you. Our suggested revisions are listed on this slide to remove exclusion 6 and to revise the indications. Thank you.

Jocelyn Fernandez:
Thank you, Dr. Rodgers for your comments, but your time is up.

Our next speaker is Dr. Peter Maki. Dr. Maki your line is open.

Dr. Peter Maki:
Okay, can everybody hear me?

Dr. Larry Clark:
We're getting some echo. You should close off your computer and phone.

Dr. Peter Maki:
Can you hear me now?

Jocelyn Fernandez:
We can hear you. Dr. Maki.

Dial tone.

Jocelyn Fernandez:
Dr. Maki, can you hear me?

Let's move on to the next speaker.

Our next speaker is Dr. Budoff?

Dr. Larry Clark:
Dr. Budoff, are you available sir?

Dr. Matthew Budoff:
Yes. I'm here. I was still muted by the organizer for a moment there. But thank you for having me.

Dr. Larry Clark:
Thank you.

Dr. Matthew Budoff:
I just make some verbal comments. I don't have any slides prepared, but I did want to first introduce myself as somebody who's been doing cardiac CT. We did our first CT angiogram and 1995. So, we've been doing this a long time in clinical practice. About 25 years and I've had the opportunity as a clinician to use the FFRCT to help guide my own clinical practice and to help other physicians guide their clinical practice and I would just say that the largest utility is to identify those patients who have stenosis on CT angio and be able to identify those as not being physiologically significant and thus not requiring further revascularization. So, saving them from invasive angiography from potentially stenting as well as revascularization. So, I'd like to first start by where Dr. Campbell was kind of left off when he was talking about the exclusions and indications. I think it's very important to simplify this the current indications are very, very specific and terms of which stenosis would qualify, and coronary artery disease is just not able to be put into very discreet buckets like that. It's unusual to think about moderate circumflex stenosis being more important than a proximal right coronary artery degree stenosis yet a proximal circumflex or a circumflex stenosis when it's left dominant is an indication and a right coronary artery disease is not an indication and that that is different than our typical clinical practice where we would consider proximal disease in any of the three major vessels as being of significant clinical risk, and therefore usually requiring further evaluation. So, if we can't use this test for example in somebody who has a right dominant circulation, and by background 85% of patients the right coronary artery is the dominant vessel. If we can't use this when they have right coronary artery disease that would be a significant limitation that would lead to more invasive angiography and more subsequent potentially stenting or revascularization because as we all know, once the patient's get into the cath lab the impetus to do something is greater for the physicians. I think the greatest benefit of this test is it allows us to identify those lesions of significant functional significance and separate that from having to make a five minute decision of whether I should put a stent in or not and letting us think about this letting us present this to the to the patients and to the referring doctors and make a good decision about what the next best step is and most often we decide not to revascularize after using FFRCT. So I would suggest that the indications and exclusions be simplified to simply state that we are use this in cases of coronary artery disease with coronary stenosis of uncertain functional significance, because again to try to put this into an exact bucket of scenarios where would apply never will replicate what goes on in the in the real world and our ability to exactly define the percent stenosis. In other words, is it a 50% stenosis, or is it a 60% stenosis, or is it a 40% stenosis in that ostium of the left main or proximal right coronary artery, is still a little bit arbitrary with cardiac CT. So, I think we have to use this like we use this in many other LCDs, where it says that when we think that there may be ischemia causing coronary disease when the provider believes a negative FFRCT will avoid invasive coronary angiography. And that in my practice maybe a stenosis of 40% or 50% in a certain proximal vessel where an interventionalist or or invasive cardiologist may may deem that important, and there is a little bit of variability between CT angiography and invasive angiography once they get to the lab. So, I would ask to make these simpler for clinical use but also to expand the the indication to coronary stenosis of uncertain functional significance. I want to finish up my comments with talking about image quality. I think that it's impossible to know the image quality of a CT based on any one parameter. There are so many different CT scanners now with different image resolution. Some scanners now are much better at dealing with obesity and therefore exclude patients based simply on a body mass index would be incorrect for these newer scanners and similarly the the image quality with high-definition detectors on many new scanners allow us to utilize these tests with things like severe coronary calcification. So, I think the HeartFlow model has worked exceptionally well for us where we send them cases where we have uncertain functional significance. They try to analyze it and if they can analyze it there is no cost to the patient, no charge to the insurance and we get feedback that this case was not interpretable. That might be in a body mass index of 34 where that might be in a body mass index of 36. But having a discrete cutoff for different body habit is just not possible. Finally and the same is true of coronary calcium where a high calcium score in some situations preclude accurate assessment and sometimes people have high calcium scores and their coronaries are very well visualized and I think that the current model of simplifying this so that it would be more usable for all parties is going to be very important. I'm not aware of any contraindication for valves in my career. I've done probably about thirty or forty thousand CTA angiograms in my practice and valves themselves do not preclude accurate assessment. So, one of the exclusion criteria is actually the presence of a prosthetic valve, which I'm prior placement of prosthetic valves, which I'm completely unaware of any data to support that for either coronary artery assessment or FFRCT assessment. So, I think that one might have been input. I don't know if that's an old hangover from something else, but I'm not aware of any data to support that and certainly in my practice the existence of prosthetic valves does not impair image quality of the coronaries under any circumstance. So, I would certainly consider severe obesity prior placement of prosthetic valves and extensive coronary calcium be removed as specific exclusions because if the FFRCT cannot be analyzed there is no charge or cost to anybody. So, the feedback on image quality becomes much more important. The last thing I just want to bring up. My remaining time is just the discordance in payments between the physician fee schedule and the HOPPS and I realize that this is not necessarily the forum but for this specific test it's remarkable the difference as my outpatient scanner that we have is a free-standing imaging center. The reimbursement is around $40 for this test, but the hospital if we just send the patient over to the hospital to get done, the reimbursement is $1,100. So, there needs to be more uniform payments. I don't understand the rationale personally. But there needs to be more uniform payments. Our better scanner is an outpatient scanner and we prefer to use that for patients. They get lower radiation and they get better image quality. But if I'm forced to use the hospital scanner just because the reimbursement is 25 times higher (one-minute remaining). Thank you, then. Then that really changes the experience for the patient and may actually be adverse for them.

So, I would ask that there would be some type of balance here where the payments are more uniform across my two scanners that I have access to literally maybe a hundred yards apart at the most, yet discrepancy in payments is so dramatic. So, I'll stop there and thank everybody for having me on the call and certainly be available for any questions or comments. If there are any that arise, thank you.

Dr. Larry Clark:
In your last 30 seconds, I just want to ask you what percentage of your patients had their initial or anticipated treatment plan revised due to your performance of FFRCT.

Dr. Matthew Budoff:
Yeah, I would say more than 50% of our patients. I think Campbell said 62% I would say we're probably in that ballpark where I would say well over half of our patients get a revision of their treatment plan based on the results of FFRCT and the vast majority are not to pursue further testing. So, we downgrade patients most commonly, though we might have been suspicious of and wanted to know more about. FFRCT says it's mild and we don't need to pursue.

Dr. Larry Clark:
Thank you. Jocelyn.

Jocelyn Fernandez:
Thank you. Dr. Budoff for your comments. We will now move back to our previous commenter. Dr. Maki we are working to open up your line. One moment, please. Dr. Maki, can you hear me?

Dr. Peter Maki:
Yes, I can hear you. Yes, I apologize for the feedback there and I appreciate the opportunity to participate in this discussion, just by way of introducing I’m an Interventional Cardiologist. I have some feedback here. I'm an Interventional Cardiologist. I've been practicing here in Phoenix for 39 years. 14 years ago, we began an Outpatient CT program in our office using 64-slice G scanners. So, we have a broad range of experience there and over the past two years, we've had a chance to use the FFRCT methodology. I also spend more than 12 years, I've kind of lost count and was the ACC carrier advisor to Arizona that chance to work with Dr. Oakes and the Dr. Bill Mangold before him. So as we know the trend in medicine is to take a much less invasive approach when it comes to evaluation and treatment the advent of drug-eluting stents and increasingly sophisticated stands has allowed us to treat lesions that previously would have just been automatically treated with bypass and now with an Interventional approach and as we deal with an aging population with more and more comorbidities, the ability to stent a vessel and not put the person to bypass has a tremendous advantage. So, this fact speaks to the exclusion in number 6 that we've been discussing with respect to known severe three vessel coronary artery disease. I think we can all agree that a middle-aged diabetic patient with critical multivessel disease and impaired LV function is not likely to benefit from FFR assessment because a cath is basically headed for the coronary bypass for complete revascularization if possible, but there are many variations on the theme of multivessel disease obviously, and the anatomy can seriously dictated obviously which direction to take as an example, if you have a critical circumflex lesion and a right coronary lesion a moderate of lesion in the LED of uncertain significance, it becomes an important determinant of whether one would consider bypass or whether you could just simply stent the circumflex in the right and consider one's job to be done. Now true one can go in the cath lab and start invasively measuring anti-foreign all these multiple lesions, but that is not without its risk can be, takes time and contrast and it's certainly it's a separate artery involved and involve additional catheters. So, it's can be a tedious process. So, the ability to do this non-invasively certainly has a major advantage in my view the indications two thru four do see more overly specific and as has been pointed out by Dr. Budoff leave out the right coronary artery, which can supply in some cases up to 30% of left ventricular myocardium. We're dealing here with symptomatic patients presumably on appropriate medical therapy and we have to be able to assess and treat the culprit vessel, whichever one that is and of course determining which vessel is likely to be the culprit is what the FFR methodology helps us with. So, in that light the proposed revision makes sense. I would also say is Dr. Rodgers is shown on the slides. We respect to the advanced registry that the process of assessing stenosis in the coronary arteries whether in the cath lab or looking at a CTA is is challenging at best and you know can sometimes it can be difficult the eyeball method in the cath lab has its limitations and every angiography is any angiographer has been humbled by looking at a lesion and being convinced it was tied or not tight and finding the option to be the case with invasive measurement. So, with this in mind, I think the extension of range of stenosis not trying to limit it to the 50th, 70% range makes a lot of sense and I think it should be changed and if at all possible in the guidelines. Dr. Rodgers also made reference to the clinical decision-making utility of FFRCT in multivessel disease. This points to the work of the syntax investigators and shows the influence of management that can derive as we've discussed. The many of us believe that at some point CTA with FFR as a partner strategy may well supplant invasive coronary angiography and multiple many scenarios may be, in all scenarios and as a bottom line, I think having the greatest understanding of what an angiographer is going in to deal with and as it was pointed out by Dr. Budoff having the ability to really discuss with the patient the pros and cons of treatment and really give true informed consent has a lot of advantages. So, thank you again for the opportunity to participate in this discussion and I'd be happy to answer any questions.

Dr. Larry Clark:
Dr. Clark again, you mentioned the syntax investigators, has that wrapped up or is that still an ongoing investigation of PCI?

Dr. Peter Maki:
Well, it's it taken different forms, and actually the most recent study that they have put out as a very interesting comparison taking angiography and creating two groups of heart teams one using the invasive and one using the CTA with FFR and correlating their decision-making with respect to bypass and angioplasty and which would be the preferred approach and the remarkable thing about that was that they came up with excellent concordance. So, it really does point to the idea that perhaps ultimately will be using CT with FFR as our primary diagnostic strategy and surgeons can just go ahead and bypass or the interventionalist can go and perform PCI. Just based on that alone.

Dr. Larry Clark:
Thank you.

Jocelyn Fernandez:
Thank you, Dr. Maki for your comments. We will now move on to commenter number four, Dr. Roger Bies.

Dr. Roger Bies:
Can you hear me?

Jocelyn Fernandez:
Yes, we can, but we're getting feedback.

Dr. Roger Bies:
Let me….I'm going to hang up my phone and hopefully the computer will carry me through. Can you hear me now?

Jocelyn Fernandez:
Yes, I can. I can hear you.

Dr. Roger Bies:
Can you hear me now?

Jocelyn Fernandez:
Hello, can you hear me? Dr. Bies I can hear you.

Dr. Roger Bies:
Can you hear me?

Jocelyn Fernandez:
Yes, loud and clear.

Dr. Roger Bies:
Oh great. Thank you so much. Yeah, thank you for the opportunity to participate in this conference along with my esteemed colleagues. I think a lot of the comments that I would have made of already been made by both Dr. Budoff and Dr. Maki. I probably will just reiterate a few things. From my own experience maybe to solidify some of those comments. I have been doing cardiac CTA here in East Valley in Arizona for 14 years and we have a robust program. We do Outpatient studies, we do a lot of structural heart and we also have a robust program in our emergency department where we screen patients with possible coronary syndromes to determine if they need to be hospitalized or not. And I know that that's one of the items here. I think number eight that I thought was worded a little bit funny. I think the wording could be changed a little bit. But right now we already discharged about 80% of patients coming in with normal EKGs and enzymes who have chest pain syndrome, that could be cardiac in nature about 80% used to be admitted to the hospital for rule out through the usually stress test or cath before cardiac CTA became available. And as we work towards the efficiency of FFRCT, we're hoping to get some of those patients that get admitted analyzed further to even reduce the number of unnecessary admissions for non-obstructive disease some of those patients end up going right now to an observation unit and having that procedure done for that some group of patients, but we have found it very useful. I would probably reiterate that 50 to 60 percent range of people where the decision-making as to whether to treat medically or go to the cath lab has been changed by CT FFR and we probably do get a reduction in the number of people undergoing invasive angiography and need for coronary revascularization when FFRCT has been performed. So, it's really is a valuable technology. Regarding the exclusions, I would reiterate a couple of items, the severe obesity one, as you know, obesity can be, you know, very relative to a person some people have very large hips and legs and small chests. The quality of scans. The image quality is really number one for both CT and FFR so, if you're not going to get a good scan, you're not going to even have interpretable CT data and so it is kind of a term where it's hard to put an actual number of 35 down and use that as a way of excluding or including someone's being eligible for both a CT or for CTFFR. So, I would remove that I'd say you know that they do a very good job if you work at a center that has a lot of experience and produces good quality scans and that's all pre-screen before you can start doing FFRCT at your site that they do a very good job of assessing those and we do get studies turned down even at a good quality site for things like calcification or motion. I don't recall us having an obesity one actually being denied or as having problems processing data that that's maybe because patients who don't fit on on the scanner or are good candidates for cardiac CT generally won't get the scan in the first place. Same thing with prosthetic valves. We do a lot of patients with prosthetic valves particularly with our structural heart program, and we get very good image quality in the coronaries. So, I'm a little surprised at what the decision was on putting that as an exclusion. I don't see there being scientific support for having that in there. And then same thing with the extensive coronary calcification. The term extensive is a descriptive term back in the day when CT was first coming up there was a large amount of data published relative to the severity of stenosis and the accuracy based on the calcium score and number of studies using four hundred and some other studies using a thousand and the more calcium the more difficult it was to interpret severity of stenosis relative to diagnostic coronary angiogram. And so I would say, you know, there are cases where the calcium can be extensive but spotty throughout the coronary tree and there's not any one lesion that's extremely bright or hard to read verses heavy calcification in one specific area that could make it extremely difficult. So again, you're it's a kind of a qualitative term that doesn't help steer you in the direction of whether this CTA image data is acceptable and whether FFRCT is going to be processed adequately and I think again the HeartFlow quality analysis does a great job of assessing which whether those studies are appropriate or not and many times even the CT itself you looking at it. You know that you're not going to get your study turned down by them. So, I think motion artifact and calcification of the two quality issues that most often get CT FFR denied in terms of processing and I'd say the ten percent range is probably pretty accurate for that. To move on the exclusion number six which talks about known severe three vessel disease, I think even if you were to use it, it's very confusing because it has indications of moderate disease say in the proximal LED or circumflex, which immediately would not be considered known three vessel disease because now you're eliminating a vessel because it has moderate disease and then excluding the right coronary which I think is still a very important vessel. And then I also had an issue with the left main stenosis the intermediate stenosis of 30 to 50% just because the angiographically or by CTA you might decide someone's going to go for surgery, but we do have patients that we manage medically and again reviewing the flow data you will have lesions that looks significant, but turn out to have normal FFRs and if you have a high-risk patient it often helps you decide to manage that patient medically rather than undergo an Interventional procedure or even bypass surgery which could end up with mortality or morbidity that could have been avoided if CT FFR had not been performed. So, I like Dr. Budoff’s suggestion of just having an indication of coronary stenosis of unknown clinical significance, whether it's 1, 2, or 3 vessel and get rid of this section all together just because I think it's not written well. It's confusing, it misses out on one vessel, it has intermediate stenosis when more severe stenosis can at a certain percentage detailed in the previous slide may have a normal FFR and again get managed more conservatively. So those are my general comments and I feel that the other two presenters did a great job expressing my additional feelings about CT FFR and maybe what the exclusion should be for this or how they should be modified. I don't have anything else to present.

Dr. Larry Clark:
Thank you.

Jocelyn Fernandez:
Thank you Dr. Bies for your comment. Our last speaker is Dr Joaquin Cigarroa. Give us some time to connect him. Is there anyone from the Society of Cardiovascular Angiography and Interventions available to speak?

Okay, this concludes the registered speakers for today's open meeting.

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

The comment period for the proposed LCD will remain open until June 21, 2020. As noted earlier all comments to be considered by our medical directors for the proposed LCD must be submitted in writing. Written comments can be emailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCDs are located on our website at noridianmedicare.com. Upon review of the comments, our medical directors will either finalize or retire the proposed LCD. Please monitor our website or register for list of notifications to be informed of actions taken to implement or retire our proposed LCDs. Also the audio recording and written transcript will be posted on our website. Dr. Clark, do you have any final comments?

Dr. Larry Clark:
Yeah. Doctor’s Rodgers and Brown have been thru this before, so I invite them if they have any additional written comments in addition to the ones that they have previously submitted. I like to just ask our other three speakers that we rely predominantly on your written commentary and while today's proceedings have been recorded. I would ask each of you and I realize you've contributed time already. If you would summarize what you want us to know about your comments today and committed to writing that would really be appreciated. We needed to do a good job in what we're doing. I thank you all for being involved everybody and our colleagues from other contractors who have to leave for another meeting. I also would like to remind everybody in attendance to pay attention to our website to see when other meanings similar to this or other carrier advisory committees are coming up and with that, I just want to say thank you and turn it back to Jocelyn.

Jocelyn Fernandez:
Before we end this meeting, let's go back and see if Dr. Joaquin Cigarroa has signed in. One moment while we try and connect him. Dr. Cigarroa is that you?

Hello, is this Mr. Powell?

Mr. Powell:
Yes this is, can you hear me?

Jocelyn Fernandez:
Yes.

Mr. Powell:
I could read the statement that Dr. Joaquin getting ready to present. He's the co-chair of the SCAIs Government Relations Committee and he wants to thank everyone for the opportunity to speak here. We're in the process of developing an official position, but we want to make a couple preliminary comments now. We've supported the development of CT diagnostic procedures including FFR or surprised to encounter policy which means all invasive FFR procedures when a non-invasive test is performed and disagree with this provision. While this non-invasive test is important risk stratification tool. It does replace invasive coronary angiography nor FFR which is the gold standard with the largest number of published studies and known benefit and selecting patients and lesions for revascularization and or deferral which in turn decreases major adverse cardiovascular events.

First we would like to emphasize the strong scientific evidence for the diagnostic performance of FFRCT as a non-invasive tool the overall accuracy of FFRCT compared to other non-invasive cardiac tests as high in our experience with patients and these observations are so cleared by the published literature in comparison to stress testing with stress echocardiography and nuclear stress testing. As such it is really a reasonable modality has a gatekeeper with regards to which patients with stable ischemic heart disease may benefit from invasive coronary angiography does not however supplant the need for invasive coronary angiography or specifically of FFR in determining lesion specification assessment in decision-making regarding the revascularization of moderate coronary lesions, the NXT trial showed that a per vessel accuracy of 86% compared to invasive FFR in 250 for patients of the Pacific study demonstrated 87 percent per vessel accuracy compared to invasive FFR higher than spectat and CCTA, but not invasive FFR you have come to rely on FFRCT for clinical decision making with regard to improving the decision-making in who's who and who not to refer to for coronary angiography. We are pleased the HeartFlow is supporting four additional research studies on those technology and in summary, we recommend the coverage for CTFFR but differ in our strong recommendation that it should not replace invasive FFR but a complementary procedure to invasive physiology not a substitution. Thank you.

Jocelyn Fernandez:
Thank you, Mr. Powell for your comments. I will ask again, Dr. Clark do you have any final comments?

Dr. Larry Clark:
Yes, sir. You reference a white paper or presentation that is coming out. What is your time frame on that? You have any preliminary information? It sounds like what you're addressing is the balance between FFR via a wire Invasive FFR and FFRCT. When are you publishing that document?

Mr. Powell:
We don't have an official weight paper in process. What we were hoping to do is get official comments approved by our board to you by your requested end of June 21st. It's going to be a struggle, but we'll try.

Dr. Larry Clark:
Thank you.