LCD Reference Article Response To Comments Article

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

A58991

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Article ID
A58991
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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
04/01/2022
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As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the proposed LCD for Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease. The official notice period for the final LCD begins on February 10, 2022, and the final determination will become effective on April 1, 2022.

Response To Comments

Number Comment Response
1

The American College of Cardiology (ACC), the Society of Cardiac Computed Tomography (SCCT), and other individuals proposed removal of the following Limitations of Coverage in their entirety: ”1. Known severe aortic stenosis, 2. Prior placement of prosthetic valves, 3. Prior placement of Pacemaker and Defibrillator leads, 4. Coronary stents.”

NGS agrees and has amended the final Local Coverage Determination to reflect the following changes: 1. The coronary stenosis range will be expanded to 40-90%, 2. The limitations related to coronary CT angiography (CCTA) image quality, i.e. BMI>39, and prosthetic valves will be removed.

The request to remove intracoronary metallic stents was accompanied by a suggested limitation which the manufacture 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.

2

One commenter requested that the “suspicion of acute coronary syndrome policy verbiage be modified to align with other MAC LCDs.”

 

While our policy is in line with other MACs, we have amended the policy. The Executive Summary was published with guidelines for use of FFRct with a moderate strength recommendation to expand the role of FFRct in specific clinical settings as an alternative to stress test.1 The LCD has been updated to reflect these guideline changes

3

Several individuals and the American College of Cardiology (ACC) “ believe the proposed policy limits coverage for a subset of those patients by explicitly narrowing it to 30-50% stenosis in the left main and 40-70% stenosis for other arteries. These percentages should be references, not absolute cutoffs, as data show patient benefit outside these specific percentages."

Please refer to Response #1

4

Several individuals and the American College of Cardiology (ACC) commented, "This policy also restricts coverage to those with severe obesity (BMI > 39 kg/m2). : "This proposed restriction should be removed or broadly expanded in order to ensure adequate access for Medicare beneficiaries. "

 

NGS agrees and has amended the final Local Coverage Determination.

5

Two individuals commented that the “Coronary stent exclusion” should be modified to reflect: “ A metallic stent present in the left main coronary artery, stenosis > 30% in the left main coronary artery and 1 or more metallic stents in the left system, Metallic stents present in 2 or more coronary systems (e.g., the left circumflex coronary artery and the left anterior descending coronary artery”

The request to remove intracoronary metallic stents was accompanied by a suggested limitation which the manufacture 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.

 

6

The Society of Cardiac Computed Tomography (SCCT) proposed that the FFRct disease characteristics found by CCTA in the proposed LCD be changed to the following:.: “ Left main disease with intermediate coronary stenosis (lumen diameter reduction of 30-50%); OR In vessels other than Left Main, coronary artery disease in any vessel with coronary stenosis of uncertain functional significance (lumen reduction 40-90%",

NGS agrees and has amended the final Local Coverage Determination to reflect the following changes: 1. The coronary stenosis range will be expanded to 40-90%, 2. The limitations related to coronary CT angiography (CCTA) image quality, i.e. BMI>39, and prosthetic valves will be removed.

7

The Heart Flow manufacturer commented, " Heart flow can process FFRCT results on patients who have had stents to one vessel. However, they can only interpret the vessels without stent. The IFU for HeartFlow states that there are 3 scenarios where FFRCT cannot be utilized (and therefore would be appropriate to not cover: a. Stent is present in the left main coronary artery b. A stenosis > 30% in the left main coronary artery and 1 or more stent in the left system, c. Stents present in 2 or more coronary systems



NGS agrees and has amended the final Local Coverage Determination to reflect the following changes: 1. The coronary stenosis range will be expanded to 40-90%, 2. The limitations related to coronary CT angiography (CCTA) image quality, i.e. BMI>39, and prosthetic valves will be removed.

8

ACC recommends removal of prosthetic valves and pacemakers/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, pending availability of new literature.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
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