Local Coverage Article Response to Comments

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

A59211

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Noridian Healthcare Solutions, LLC	A and B MAC	01111 - MAC A	J - E	California - Entire State
Noridian Healthcare Solutions, LLC	A and B MAC	01112 - MAC B	J - E	California - Northern
Noridian Healthcare Solutions, LLC	A and B MAC	01182 - MAC B	J - E	California - Southern
Noridian Healthcare Solutions, LLC	A and B MAC	01211 - MAC A	J - E	American Samoa Guam Hawaii Northern Mariana Islands
Noridian Healthcare Solutions, LLC	A and B MAC	01212 - MAC B	J - E	American Samoa Guam Hawaii Northern Mariana Islands
Noridian Healthcare Solutions, LLC	A and B MAC	01311 - MAC A	J - E	Nevada
Noridian Healthcare Solutions, LLC	A and B MAC	01312 - MAC B	J - E	Nevada
Noridian Healthcare Solutions, LLC	A and B MAC	01911 - MAC A	J - E	American Samoa California - Entire State Guam Hawaii Nevada Northern Mariana Islands

Article Information

General Information

Article ID
A59211

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

Article Type
Response to Comments

Original Effective Date
09/18/2022

Retirement Date
N/A

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Article Guidance

Article Text

The following are the comments and contractor responses for Noridian Healthcare Solutions Proposed Local Coverage Determination (LCD) DL38613 Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease which was posted for comment from 01/20/2022 thru 03/05/2022, and presented at the Open Meeting on February 24, 2022. All comments were reviewed and incorporated into the final LCD where applicable.

References:

1. Gulati M, Levy PD, Mukherjee D, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. 2021:CIR. 0000000000001030.

2. Maron DJ, Hochman JS, O'Brien SM, et al. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial: Rationale and design. Am Heart J. 2018;201:124-135.

3.Vavere AL A-ZA, Rochitte CE, et al. Coronary artery stenoses: accuracy of 64detector row CT angiography in segments with mild, moderate, or severe calcification–a subanalysis of the CORE-64 trial. . Radiology 2011;261:100-108.

4. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. Journal of the American College of Cardiology. 2018;71(24):2756-2769.

5. De Bruyne B, Pijls NH, Kalesan B, et al. Fractional flow reserve–guided PCI versus medical therapy in stable coronary disease. J New England Journal of Medicine. 2012;367(11):991-1001.

6. Michail M, et al. CAST-FFR study, Feasibility and Validity of Computed Tomography - Derived Fractional Flow Reserve in Patients with Severe Aortic Stenosis: Circulation. Cardiovascular Interventions. 2021;14(1).

7. Collet C, Miyazaki Y, Ryan N, et al. Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. J Am Coll Cardiol. 2018;71(24):2756-2769.

Response To Comments

Number	Comment	Response
1	Language clarification – stenosis range <50% vs. 40% (received from 4 commenters).	In patients with non-obstructive CAD (<50% stenosis) who have persistent symptoms despite maximized medical management the pathway leads to options for further evaluation with CCTA or stress test. If CCTA is performed and =40-90% stenosis is found on this new study than FFRCT may be used to aid in further evaluation.⁵ General agreement with statement submitted by SCCT: Inclusion of Intermediate-risk patients with acute chest pain and no known coronary artery disease, with coronary artery stenosis of 40-90% in proximal or middle coronary artery on CCTA. The policy will remain consistent with the 2021 AHA/ACC Guidelines1. The restriction from <50% to <40% was revised in draft for consistency.
2	Language clarification (received from 3 commenters) – persistent symptoms definition Question raised as to definition of “persistent symptoms”. Does this mean that symptoms persist despite optimal medical therapy, or does it mean that the symptoms have been present for some period of time (whether or not optimal medical therapy was instituted)?	Persistent is defined by symptoms that persist despite optimal medical therapy. Optimal medical therapy is defined by ISCHEMIA trial protocol² as unacceptable ischemia-related symptoms despite maximally tolerated medical therapy. This includes at least two anti-anginal drugs from different drug classes added to beta-blocker therapy and titrated to maximally tolerated doses before medical therapy is considered to have failed. This has been added to the policy for clarification.
3	Location of stenoses (received from 2 commenters). In the indication that addresses FFR for stable CAD, there is no requirement that the stenosis be in the proximal or middle segment of the coronary artery, as is the case for acute CAD indications. Is this intentional or is it an oversight? We suspect it is an oversight because, in general, distal CAD is not managed with revascularization in which case FFR is not particularly helpful in clinical decision making.	The 2021 AHA/ACC/ASE/ CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain states “For intermediate-high risk patients with stable chest pain and known coronary stenosis of 40% to 90% in a proximal or middle coronary segment on CCTA, FFR-CT can be useful for diagnosis of vessel-specific ischemia and to guide decision-making regarding the use of coronary revascularization ”. The policy will remain consistent with the 2021 Guidelines.
4	Concurrent use with stress testing (3 commenters). Patients who have undergone stress testing are excluded from consideration for FFR. We suggest that the authors consider the following: a. If stress testing is inconclusive, CCTA and FFR may have a role in patient management. b. If stress testing is performed without imaging, and is positive, and CCTA shows more than one obstructive lesion, FFR may be useful in determination of the flow limiting significance of each lesion thereby guiding PCI decisions.	If stress testing is inconclusive, CCTA and FFR may have a role in patient management. We agree that FFR-CT may be a reasonable alternative when stress test is inconclusive, and policy updated accordingly. If stress testing is performed without imaging, and is positive, and CCTA shows more than one obstructive lesion, FFR may be useful in determination of the flow limiting significance of each lesion thereby guiding PCI decisions. This was not accompanied by supporting literature if such literature is published, please submit with reconsideration.
5	CTA Imaging Limitations (due to prosthetic valves, pacemaker and defibrillator leads) (4 commenters). Remove restrictions related to image quality, valves (Restriction 1), known severe aortic stenosis (Restriction 2) and pacemaker or defibrillator leads (Restriction 8).	There are several reasons we will not remove these limitations at this time: a. This policy is foundational so covers any technology that would provide equivalent service. If a new product that is equivalent to what is currently available emerges it will be held to the requirements within this policy. While current technology returns the images if quality is low, we cannot assume that will be the case for all future technologies. b. To ensure safety and accurate of results literature is needed to support the removal of these limitations. Pivotal trails consistently excluded patients with prior percutaneous coronary interventions. c. Incomplete reporting of coronary artery anatomy defeats the purpose of this diagnostic test therefore does not meet the requirements for payment. If literature or guidelines provide support for the safety and accuracy for CCTA and FFRCT in this population that can be evaluated with reconsideration.
6	Impact of coronary plaque on CCTA (and subsequent FFRct determinations) (3 commenters). With the development of new technologies in CCTA, presence of extensive plaque or calcification does not necessarily exclude the use of FFRCT³. We recommend the use of FFRCT if there is adequate image quality. Recommend removing “If extensive plaque is present a high quality CCTA is unlikely and stress testing is preferred.” Syntax 3 and FAME studies were submitted in support of this position.	The Syntax 3 study⁴ suggests that the overestimation of CTA-SS was corrected by FFR-CT, resulting in higher correlation to invasive angiogram than CTA alone. This was reproduced in the FAME trial⁵. Therefore, the statement regarding excessive plaque formation is removed from the policy.
7	Accuracy in the setting of severe Aortic Stenosis (4 Commenters). All requestors favored the removal of this prohibition of usage from the policy. All cited the same evidence noted below.	The 2021 CAST-FFR study supports FFR-CT in the setting of severe aortic stenosis so this limitation is removed from the policy.⁶
8	Intracoronary metallic stents (3 commenters). One technology asserted that it can process FFRCT results on patients who have had stents to one vessel. However, they can only interpret the vessels without stent. The Indications for Use state 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	a. This policy is foundational so covers any technology that would provide equivalent service. If a new product that is equivalent to what is currently available emerges it will be held to the requirements within this policy. While current technology returns the images if quality is low, we cannot assume that will be the case for all future technologies. b. To ensure safety and accurate of results literature is needed to support the removal of these limitations. Pivotal trails consistently excluded patients with prior percutaneous coronary interventions.^4,7 c. Incomplete reporting of coronary artery anatomy defeats the purpose of this diagnostic test therefore does not meet the requirements for payment. If literature or guidelines provide support for the safety and accuracy for CCTA and FFRCT in this population that can be evaluated with reconsideration.
9	Inclusion of stable and acute chest pain (3 commenters). Request for inclusion of both indications based on ACC/AHA Guidelines cited in both requests.	“Stable and acute chest pain” has been added to align with ACC/AHA Chest Pain Guidelines.¹
10	Combine the two indications for “no known” and “known” CAD (1 commenter). One request was received to combine the two indications for “no known” and “known” CAD into one, as once a CCTA is performed and FFRCT ordered, CAD is always “known”.	In the 2021 AHA/ACC/ASE/ CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain¹ the algorithm for suspected ACS at Intermediate Risk with No Known CAD and Known CAD are separate. Based on this algorithm FFRCT is a sequential test, therefore the evaluation and treatment plan may lead to CCTA in defined clinical scenarios. Based on the CCTA results the patient may benefit from FFR-CT or stress testing. As there is a possible divergence of clinical pathways, the policy language will remain consistent with the 2021 Guidelines.
11	Inclusion of Additional Diagnoses Codes other than R93.1 (1 commenter). One request was received to add additional diagnoses codes other than R93.1-Abnormal findings on diagnostic imaging of heart and coronary circulation.	After substantial discussion, it was decided to maintain this diagnosis as uniquely accurate as the clinical decision to use this service (of data reprocessing) is based on the abnormal findings on previously obtained diagnostic imaging.

Associated Documents

Related Local Coverage Documents
Articles
A58095 - Billing and Coding: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease
LCDs
L38613 - Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease

Updated On	Effective Dates	Status
07/27/2022	09/18/2022 - N/A	Currently in Effect	You are here
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Response to Comments: Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease

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