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 (e.g., HealthCCSng)

Automated quantification of CCTA images using artificial intelligence (AI)-based software applications (e.g., 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 (e.g., 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

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

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. (Refer to Coverage Limitations section)

Three-dimensional (3D) predictive model generation using CCTA data has been proposed to aid in planning such procedures as coronary revascularization, heart valve repair/replacement and left atrial appendage closure. Examples of computer-aided design software used for this purpose include Mimics Enlight and Vitrea CT Cardiac Analysis. (Refer to Coverage Limitations section)

Coverage Determination

Any state mandates for coronary computed tomography angiography, fractional flow reserve with computed tomography or coronary artery calcium scoring take precedence over this medical coverage policy.

Coronary Computed Tomography Angiography

Humana members may be eligible under the Plan for coronary computed tomography angiography (CCTA) when the following criteria are met:

• Absence of contraindications; AND
• Coverage of this modality for coronary artery assessment is limited to scanners that process thin, high resolution slices (1 mm or less); multidetector row scanner must have at least 64 slices per rotation capability (collimations of at least 32x2 or 64x1) and with gantry rotation times of 420 milliseconds or less; AND
• Results obtained via CCTA are expected to add information needed for medical management;

AND any of the following:

1. Arrhythmogenic right ventricular dysplasia (ARVD) suspected; OR
2. Cancer therapy (eg, chemotherapy, chest irradiation) with stable symptoms (eg, chest pain, dyspnea, irregular heartbeat) and evaluation of any of the following:
   • Cardiomyopathy with low to intermediate risk for CAD (based on the ACC ASCVD Risk Estimator Plus); OR
   • Left ventricular dysfunction with increased bleeding risk due to cancer therapy-related coagulopathy or thrombocytopenia; OR
   • Radiation-induced CAD; OR
3. Chest pain* with any of the following:
   • Intermediate risk (based on the American College of Cardiology [ACC] ASCVD Risk Estimator Plus) with:
     • Acute or stable** with known CAD, including nonobstructive (less than 50% stenosis); OR
     • Acute or stable** with suspected CAD; OR
     • Inconclusive stress test; OR
   • Stable** with intermediate to high risk (based on the ACC ASCVD Risk Estimator Plus) with no known CAD after a negative or inconclusive evaluation for acute coronary syndrome (ACS); OR
   • Stable** with need for evaluation of bypass graft or stent patency (diameter greater than or equal to 3 mm) within 12 months following coronary artery revascularization; OR
4. Congenital anomalies of the coronary circulation suspected; OR

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0350-022 Page: 4 of 26

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Dyspnea with cardiac origin suspected; OR
• Electrophysiological procedure planned (eg, electrophysiological testing, ablation, intervention); OR
• Hypertrophic cardiomyopathy with risk of coronary atherosclerosis when:
  • Other noninvasive imaging is not feasible or is inconclusive; OR
  • Surgical myectomy planned; OR
• Left bundle branch block, congestive heart failure (CHF), or myocardial systolic or diastolic dysfunction with suspected CAD etiology; OR
• Left ventricular ejection fraction (LVEF) assessment used in the evaluation of heart failure (HF) for initial diagnosis when transthoracic echocardiography (TTE) is unable to accurately evaluate cardiac structure and function; OR
• Liver transplant candidate AND either of the following:
  • Known CAD and no coronary angiography within the last 12 months; OR
  • Suspected CAD at high risk for CAD (based on the ACC ASCVD Risk Estimator Plus); OR
• Thoracic aortic disease (known or suspected) unable to be accurately assessed or following inconclusive echocardiography, as indicated by:
  • Coarctation of the aorta; OR
  • Postoperative monitoring of thoracic aortic surgery performed within the last 12 months; OR
  • Thoracic aortic aneurysm or dilatation; OR
  • Thoracic aortic repair planned; OR
• Valvular heart disease as indicated by:
  • Bicuspid aortic valve when morphology of the aortic sinuses, sinotabular junction or ascending aorta cannot be accurately assessed or following inconclusive echocardiography; OR
  • Native or prosthetic cardiac valvular mass with pericardial dysfunction inadequately visualized using other noninvasive methods; OR
  • Secondary mitral regurgitation; OR
  • Transcatheter aortic valve replacement (TAVR) planned (for information regarding coverage determination/limitations for TAVR, please refer to Transcatheter Valve Procedures Medical Coverage Policy)

*Chest pain includes pain, pressure, tightness or discomfort in the chest, shoulders, arms, neck, back, upper abdomen or jaw, as well as shortness of breath and fatigue and should all be considered anginal equivalents.¹²

**Acute chest pain occurs when the onset is new or involves a change in pattern, intensity or duration compared with previous episodes in an individual with recurrent symptoms. Stable chest pain occurs when symptoms are chronic and associated with consistent precipitants such as exertion or emotional stress.¹²

Note: The criteria for CCTA are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Fractional Flow Reserve with Computed Tomography

Humana members may be eligible under the Plan for fractional flow reserve with computed tomography (FFRCT) when the following criteria are met:

• Absence of contraindications; AND
• Evaluation of an individual with a CCTA which has shown CAD with 40-90% stenosis in a proximal or middle coronary artery

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0350-022 Page: 7 of 26

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Coronary Computed Tomography Angiography

Humana members may NOT be eligible under the Plan for computed coronary tomography angiography (CCTA) for any indications other than those listed above including, but may not be limited to:

• For screening purposes only; OR
• Normal CCTA or coronary angiogram without stenoses or plaque within the last 2 years; OR
• Normal stress test (with adequate stress) within the last year when symptoms are unchanged; OR
• Pretest knowledge of extensive coronary artery disease (greater than 90% stenosis)

These are considered not medically necessary as defined in the member's individual certificate. Please refer to the member's individual certificate for the specific definition.

Humana members may NOT be eligible under the Plan for CCTA with any of the following contraindications:

• Clinical instability (eg, acute respiratory distress, systolic blood pressure less than 90 mmHg, unstable arrhythmia); OR
• Contraindication to beta blockade in the presence of an elevated heart rate and no alternative medications available for achieving target heart rate (less than 65 bpm) during scan acquisition; OR
• Contraindication to nitroglycerin (if indicated); OR
• Heart arrhythmia and variability; OR
• Inability to cooperate with scan acquisition and/or breath-hold instructions; OR
• Individual has an allergy or intolerance to iodinated contrast material; OR
• Renal function impairment when the risk of nephrotoxicity with contrast agents outweighs the benefit of the CCTA

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Fractional Flow Reserve with Computed Tomography

Humana members may NOT be eligible under the Plan for fractional flow reserve with computed tomography (FFRCT) for any indications other than those listed above including, but may not be limited to:

• ACS suspected when acute myocardial infarction or unstable angina have not been ruled out; OR
• Body mass index (BMI) greater than 35; OR
• Complex congenital heart disease; OR
• Coronary vessels with greater than 90% stenosis; OR
• Intracoronary metallic stents; OR
• Prior coronary artery bypass graft (CABG) surgery; OR
• Prior pacemaker or internal defibrillator lead implantation; OR
• Prosthetic heart valves; OR
• Recent prior myocardial infarction within 30 days; OR
• Require emergent procedures or have evidence of active clinical instability including:
  • Acute pulmonary edema; OR

Coronary CT Angiography, Fractional Flow Reserve with CT, Calcium Scoring Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0350-022 Page: 9 of 26

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Cardiogenic shock; OR
• CHF, New York Heart Association [NYHA] III or IV; OR
• Sudden onset chest pain*; OR
• Unstable blood pressure (BP) with systolic BP less than 90 mmHg; OR

Unstable arrhythmias or tachycardia (uncontrolled by medication) that would preclude CCTA acquisition

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Adjunctive Testing

Humana members may NOT be eligible under the Plan for:

• 3D predictive model generation for cardiac procedure preplanning (eg, Mimics Enlight, Vitrea CT Cardiac Analysis)
• Automated plaque quantification using artificial intelligence-based CT imaging software (eg, Cleerly, HeartFlow Plaque Analysis); OR
• Coronary artery calcium (CAC) scoring tests (eg, EBCT, HealthCCSng, multi-slice CT, UFCT); OR
• HeartFlow Planner; OR
• HeartFlow RoadMap; OR
• Noninvasive arterial plaque analysis (eg, ElucidVivo); OR

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about CAD may be found from the following websites:

• American Heart Association
• National Library of Medicine

Medical Alternatives

Alternatives to CCTA, FFRCT, CAC scoring or other adjunctive testing include, but may not be limited to, the following:

• Coronary angiogram
• Fractional flow reserve (as component of coronary angiogram)
• Stress echocardiography
• Stress EKG
• Stress radionuclide myocardial perfusion imaging (PET or SPECT)

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.