Humana Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring - Medicare Advantage Form

Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

Jurisdiction

• Type
• Title
• ID Number
• Medicare Administrative
• Applicable States/Territories

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Page: 2 of 10

NCD Computed Tomography

• LCD LCA Coronary Computed Tomography Angiography (CCTA) J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE IN, MI
• LCD LCA Category Ill Codes L35490 A56902 J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE IN, MI
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease L38839 AS58473 J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation IA, KS, MO, NE IN, MI
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease L39075 A58814 J6 - National Government Services, Inc. (Part A/B MAC) JK - National IL, MN, WI

JK - National Government Services, Inc. (Part A/B MACCT, NY, ME, MA, NH, RI, VT LCD LCA Cardiac Computed Tomography (CCT) and Coronary Computed|L33559 A56737 J6 - National Government Services, Inc. (Part A/B MAC)IL, MN, WICoronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Page: 3 of 10

Tomography Angiography (CCTA)

• JK - National Government Services, Inc. (Part A/B MAC CT, NY, ME, MA, NH, RI, VT
• LCD LCA ; Cardiovascular Nuclear 10) Medicine L33560 =22200 AS56743 J6 - National Government Services, Inc. (Part A/B MAC) iL, MN, WI
• JK - National Government Services, Inc. (Part A/B MAC CT, NY, ME, MA, NH, RI, VT
• LCD LCA | aac cemmed omoeen | Tomography Angiography (CCTA) sar AS56451 | 5-c6s Administrators, LLC (Part A/B MAC (Part A/ ) KY, OH
• LCD LCA Cardiovascular Nuclear Medicine L33960 AS6494 — J15 - CGS _ Administrators, LLC (Part A/B MAC) KY, OH
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease 138771 AS58359 —— J15 - CGS Administrators, LLC (Part A/B MAC) KY, OH
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Ischemic F Heart Disease 138613 A58095 — JE - Noridian Healthcare ; Solutions, LLC eee moa ’ Guam, Northern . Mariana Islands
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Ischemic Heart Disease 138615 ‘A5S8097 — JF - Noridian Healthcare Solutions, LLC AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY
• LCD Cardiology Non-emergent . . Outpatient Stress Testing L35083 NEED? A56423 JH- Novitas Solutions, Inc. (Part A/B MAC) AR, CO, NM, OK, TX, LA.

• LCA JL - Novitas Solutions, Inc. (Part A/B MAC) DE, D.C., MD, NJ, PA

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Page: 4 of 10

• LCD LCA Cardiac Computed Tomography and Angiography (CCTA) L33423 A56691 JL - Novitas Solutions, Inc. (Part A/B MAC)
• JJ - Palmetto GBA (Part A/B MAC) JM - Palmetto GBA (Part A/B MAC) AL, GA, TN NC, SC, VA, WV
• LCD LCA Non-Invasive Fractional Flow Reserve (FFR) for Stable Ischemic Heart Disease 138278 A58406 JJ - Palmetto GBA (Part A/B MAC) JM - Palmetto GBA (Part A/B MAC) AL, GA, TN NC, SC, VA, WV
• LCD LCA Cardiology Non-emergent Outpatient Stress Testing L38936 A56952 JN — First Coast Service Options, Inc. (Part A/B MAC) FL, PR, U.S. VI

Description

Coronary computed tomography angiography (CCTA) is a noninvasive imaging modality designed to be an alternative to invasive cardiac angiography (cardiac catheterization) for diagnosing coronary artery disease (CAD) by visualizing the blood flow in the coronary arteries. Other uses for CCTA include, but may not be limited to, assessment of congenital coronary anomalies, thoracic aortic disease and valvular heart disease.

Fractional flow reserve (FFR) is a physiologic indicator used to identify significantly restricted coronary artery blood flow in an individual with known or suspected CAD. FFR with computed tomography (FFRCT) uses simulated pressure, velocity and blood flow information generated from static CCTA images to determine the fraction of maximal coronary blood flow that can be achieved in a restricted artery. The HeartFlow FFRCT Analysis is an example of a Food & Drug Administration (FDA) approved software device that obtains the FFRCT noninvasively from previously acquired CCTA image data to create three-dimensional (3D) images of the coronary arteries. FFRCT is intended as a first line testing alternative to invasive FFR measurement with a pressure catheter. Analysis results assist cardiologists in determining the individual’s need for intervention such as angioplasty or stent placement.

Coronary artery calcium (CAC) scoring is a noninvasive test that has been reported to detect the presence of subclinical CAD by measuring the extent and characterization of calcium in the coronary arteries. The presence of CAC reportedly correlates with the extent of atherosclerotic plaque as well as the severity of CAD. Tests to determine CAC scoring include:

• Electron beam computed tomography (EBCT), also known as ultrafast computed tomography (UFCT)
• Multi-slice computed tomography (CT) for CAC scoring
• Quantitative CT tissue characterization using post-processing software (eg, HealthCCSng)

Automated quantification of CCTA images using artificial intelligence (AI)-based software applications (eg, Cleerly, HeartFlow Plaque Analysis) to characterize coronary atherosclerotic plaque is reported to determine the severity of coronary disease. The software application purportedly reduces evaluation time and optimizes treatment planning.

Noninvasive arterial plaque analysis is performed using an image analysis software system (eg, ElucidVivo) to evaluate multidimensional digital CTA images of arterial vessels. The image analysis reportedly aids clinicians in characterizing arterial plaque morphology (geometry and tissue composition) to assist with diagnosis and treatment planning.

The HeartFlow Planner and HeartFlow RoadMap are adjunctive testing software applications used to evaluate coronary artery anatomy. The HeartFlow Planner utilizes a coronary anatomy model and physiology simulation created from the HeartFlow FFRCT Analysis. The physician is purportedly able to identify stenoses and virtually modify the vessel.

For each treatment scenario, HeartFlow Planner will display the modified FFRCT values in real time to enable the physician to understand the impact of the modeled treatment strategy. Common scenarios for using HeartFlow Planner include focal stenoses, serial stenoses, and borderline cases. The HeartFlow RoadMap is a recently FDA-approved AI-powered software product that purportedly enables visualization and quantification of the location and severity of coronary artery stenosis on CCTA.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

Please refer to the above CMS guidance for coronary CT angiography, fractional flow reserve with CT and calcium scoring.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria.

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage