LCD Reference Article Response To Comments Article

Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease

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Article ID
A58635
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Article Title
Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease
Article Type
Response to Comments
Original Effective Date
04/26/2021
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The comment period for the Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease L38615 began on 05/07/2020 and ended on 06/21/2020. Comments were received from the provider community. The notice period begins on 03/11/2021 and ends 04/25/2021. The LCD becomes final on 04/26/2021.

In addition to the Carrier Advisory Committee meeting (recording and transcript maintained), Noridian received 17 written comments regarding this draft policy. The Commenters ranged from individual and group practices to major societies and stakeholders. We especially thank the Society for Cardiovascular Angiography and Intervention, the Society for Cardiovascular Computed Tomography and the American College of Cardiology for responses coordinated on behalf of their membership. As this policy matured into a collaborative effort with other contractors, these responses incorporate major themes presented to other contractors as well. Comments received by Noridian will be archived with the policy.

Response To Comments

Number Comment Response
1

Limitation due to body mass BMI>35.

Noridian has modified this exclusion to 39 kg/m2, largely in response to recommendations from the SCCT and the ACC. Some credible arguments regarding dual source CT and wide-detector scanning improvements were submitted. While we as contractors are not prepared to accept complete removal of obesity related anatomic concerns, we will follow the progress made with these new technologies and consider future removal of anatomic restrictions.

2

Limitation due to Vascular calcification.

Multiple commenters cited the NXT trial as evidence of the accuracy of FFRct in a wide range of patients with varying degrees of calcification. The authors of the study concluded that “there was no statistically significant difference in per-patient or per-vessel diagnostic accuracy… of FFRct across Agatston Score quartiles.” In deference to these comments, Noridian will remove this prohibition, again while reviewing the consistency of these technologies.

3

Limitation of 3-vessel disease patients.

Numerous comments were received on this issue. A typical comment is included.

I would suggest re-considering would be in the patient with known triple-vessel CAD as well as in the evaluation of saphenous vein bypass grafts. First, in patients with known triple-vessel CAD, selective vessel FFR can help determine physiologic significance and whether a patient really needs coronary artery bypass graft surgery or can be treated safely by PCI or even medical therapy until disease progresses. For patients with prior bypass grafts, I personally feel that CCTA with FFR can be very valuable in these patients, as sometimes bypass grafts can be hard to find and cannulate during coronary angiography, whereas noninvasive CCTA combined with FFR may be valuable in these patients.

We understand the potential clinical value of a non-invasive technology in a setting where invasive measures represent a potentially higher risk to the patient. However, this was not accompanied by supporting literature of use in this population and the pivotal studies excluded these patients. It is unclear if the greater risk they inherently have due to their underlying cardiovascular disease can impact the accuracy or interpretation in this group since it was not studied. If additional literature provides support for inclusion of this group, it can be re-evaluated through reconsideration.

4

Metallic stents-Noridian received multiple comments regarding inclusion/exclusion of this diagnostic modality in patients with CAD and prior stenting with metallic stents. The SCCT made specific reference to removal of this limitation.

The request to remove intracoronary metallic stents was accompanied by a suggested limitation which the manufacturer provided as appropriate exclusion in the setting of stents, but without supporting literature. The challenges in reproducible image quality is a known limitation of the technology in the presence of intracoronary stenting. Moreover, the pivotal trials consistently excluded patients with prior percutaneous coronary intervention from participation. Upon review, we find no basis for coverage with the currently available evidence. Incomplete reporting of coronary artery anatomy defeats the purpose of this diagnostic testing therefore does not meet the requirements for payment. Upon availability of evidence to support the efficacy of FFRCT analysis in the presence of intracoronary stents, we can reconsider coverage upon request.

5

Failure to reference the Right coronary artery

Noridian acknowledges the accuracy of this comment, received from numerous authors, and has amended the policy with inclusion.

6

Boston Scientific respectfully requests that the restriction of coverage for FFR data obtained by pressure wire at catheterization, should it be performed in addition to FFRct, be removed from the proposed LCD. They cite Driessen et al that only 83% of vessels can be evaluated within demonstrate only 70% accuracy to FFRct leaving a clinical need for FFR obtained by pressure wire even after FFRct in some cases. Philips comments are focused on the proposed LCD’s coverage limitation that Medicare will not pay for both FFRct and FFR obtained by pressure wiring catheterization in the context the same clinical evaluation, or onset of new symptom complex. Philips opposes this limitation for the following reasons and urges Noridian to remove the limitation in any final policy. SCCT request removal of the language prohibiting payment of both FFRCT and invasive FFR used in the same episode of care. The ACC recommends the restriction of coverage for FFR data obtained by pressure wire at catheterization, should it be performed in addition to FFRct, be removed from the LCD.

Thank you for your comments, we agree, and this has been removed from the policy. We recognize that FFRct is a valuable tool but does not have equivalency of invasive FFR. We understand there are rare but notable circumstances where the FFRct may not be accurate and confirmation with invasive FFR is needed. In addition, there are false positives FFRct cases in which case invasive FFR may prevent unnecessary stenting, or to assess for residual ischemia after stenting.

7

Consider removal of FFRct utilization in patients with suspected acute coronary syndrome (ACS) to align with the FDA label. SCCT also requests the removal of suspicion of acute coronary syndrome.

We respectfully disagree. The studies on FFRct are largely limited to the population with stable coronary artery disease. While there is preliminary literature on use in the ACS population this was based on prospective observational data without randomization and duration of follow-up was short term only (Chinnaiyan, Safian et al. 2020). While CTA results can be obtained rapidly since FFRct currently must be sent out and results not immediately available the inability to get real time results of FFRct is a barrier for use in acute situations.

In addition, the current FDA label states stable symptomatic patients with CAD removal of this limitation from the FDA-validated filings would be required prior to any reconsideration of use in this population.

8

Multiple Commenters and the ACC question limitation in the clinical settings of prosthetic valves and pacemakers and defibrillators.

Strict adherence to careful patient selection contributed significantly to demonstrating the net health benefit for FFRct. No supporting research was submitted to support removal of prosthetic value, or pacemakers. Pivotal trials for FFRCT consistently excluded patient populations with prosthetic valves and pacemakers from study. Furthermore, these limitations are reported by the manufacturer in FDA filings. Due to the unavailability of U.S.-based, high-quality, peer-reviewed published clinical research in this patient populations we must conclude that it is still investigational and therefore unreasonable to consider for coverage at this time. Upon availability of this evidence, as well as removal of this limitation from the FDA-validated filings, we can reconsider this coverage limitation upon request. The limitation will remain as written.

9

Removal of aortic stenosis and newly diagnosed left ventricular heart failure (as limitations) without prior catheterization.

There was no literature submitted to support the removal of this limitation and to provide evidence for use in this population and the pivotal studies excluded these patients. It is unclear if the greater risk they inherently have due to their underlying cardiac disease can impact the accuracy or interpretation of FFRct. If additional peer-reviewed published literature provides support for inclusion of this group, it can be re-evaluated through reconsideration.

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Associated Documents

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Medicare BPM Ch 15.50.2
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