Computed Tomography Angiography (CTA) Page 1 of 7

Version 3.0 Johns Hopkins HealthCare LLC Policy Number CMS03.09 Medical Policy Effective Date 08/03/2020 Medical Policy Review Date 04/19/2020

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 1 of 7

This document applies to the following Participating Organizations: EHP Johns Hopkins Advantage MD Priority Partners US Family Health Plan

Keywords: Cardiac, Computed Tomography Angiography, pulmonary vein mapping

Table of Contents Page Number I. ACTION 1 II. POLICY DISCLAIMER 1 III. POLICY 1 IV. POLICY CRITERIA 2 V. DEFINITIONS 3 VI. BACKGROUND 4 VII. CODING DISCLAIMER 4 VIII. CODING INFORMATION 5 IX. REFERENCE STATEMENT 5 X. REFERENCES 6 XI. APPROVALS 7

I. ACTION New Policy X Revising Policy Number CMS03.09 Superseding Policy Number Retiring Policy Number

II. POLICY DISCLAIMER Johns Hopkins HealthCare LLC (JHHC) provides a full spectrum of health care products and services for Employer Health Programs, Priority Partners, Advantage MD and US Family Health Plan. Each line of business possesses its own unique contract and guidelines which, for benefit and payment purposes, should be consulted first to know what benefits are available for reimbursement.

Specific contract benefits, guidelines or policies supersede the information outlined in this policy.

III. POLICY For Advantage MD refer to: Medicare Coverage Database

• No Local Coverage Determinations (LCDs) (Novitas) or National Coverage Determination (NCD) for Computed Tomography Angiography identified (Accessed 4/23/2020).

For Employer Health Programs (EHP) refer to:

• Plan specific Summary Plan Descriptions (SPD's)

For Priority Partners (PPMCO) refer to: Code of Maryland Regulations

© Copyright 2020 by The Johns Hopkins Health System Corporation and/or The Johns Hopkins University Version 3.0 Johns Hopkins HealthCare LLC Policy Number CMS03.09 Medical Policy Effective Date 08/03/2020 Medical Policy Review Date 04/19/2020

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 2 of 7 • No specific information located in COMAR 10.67.01 – 10.67.13 (Accessed 4/21/2020).

For US Family Health Plan (USFHP) refer to: Tricare Policy Manuals

• TRICARE Policy Manual 6010.60-M, April 1, 2015, Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging)

IV. POLICY CRITERIA A. When benefits are provided under the member’s contract, JHHC considers Computed Tomography Angiography using 64 slices or greater and 1mm or greater resolution medically necessary ONLY when ANY ONE of the following criteria are met: 1. Computed Tomography Angiography is ordered to assess for coronary atherosclerotic disease for one of the following cardiovascular indications: a. Evaluation of persons with low to intermediate pre-test probability of coronary artery disease, by American College of Cardiology ASCVD Risk Estimator Plus criteria, with chest pain , OR; b. Evaluation of persons at intermediate pre-test probability of coronary heart disease who have had an equivocal exercise or pharmacological stress test, OR; c. Evaluation of persons at intermediate pre-test probability of coronary heart disease with chest pain presenting to the emergency department when an imaging stress test or coronary angiography are being deferred as the initial imaging study, or when CT would result in a more expeditious work-up and discharge, OR; d. Evaluation of persons at low pre-test probability who have had an unexpectedly positive exercise or pharmacologic stress test, OR; e. Preoperative assessment in persons scheduled to undergo 'high-risk" noncardiac surgery, where an imaging stress study is not feasible to be performed. The American College of Cardiology defines high-risk surgery as emergent operations, especially in the elderly, aortic and other major vascular surgeries, peripheral vascular surgeries, and anticipated prolonged surgical procedures with large fluid shifts and/or blood loss involving the abdomen and thorax, OR; f. Preoperative assessment for planned noncoronary cardiac surgeries including valvular heart disease, congenital heart disease, and pericardial disease, in lieu of cardiac catheterization as the initial imaging study, OR; g. Detection and delineation of suspected coronary anomalies in patients with suggestive symptoms (e.g., angina, syncope, arrhythmia, and exertional dyspnea without other known etiology of these symptoms in children or young adults) or prior suggestion of coronary anomalies by catheterization, OR; h. Persons with documented cardiomyopathy of unknown etiology in whom identification of coronary artery disease as the cause would result in altered therapy, OR; i. The evaluation of the amount of calcium in the area of the coronary arteries can be used to see if Computed Tomography Angiography can be performed without being obscured.

2. Computed Tomography Angiography is ordered for assessing cardiac structure and morphology for guiding cardiovascular procedures for ONE of the following indications: a. Evaluation of the pulmonary veins in persons undergoing pulmonary vein isolation procedures for atrial fibrillation (pre- and post-ablation procedure, OR; b. Evaluation of persons needing biventricular pacemakers to accurately identify the coronary veins for lead placement, OR; c. Evaluation of ventricular structure and morphology prior to ventricular tachycardia ablation; OR; d. Evaluation of left atrial appendage morphology and structure prior to implantation of a left atrial appendage close device; OR e. Evaluation of left atrial appendage patency prior to cardioversion for atrial arrhythmia; OR;

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 3 of 7 f. Evaluation of cardiac valves prior to transcutaneous valve replacement

3. Computed Tomography Angiography is ordered to evaluate cardiac structure and morphology in congenital heart disease such as for ONE of the following indications: a. Pulmonary outflow tract obstruction, OR; b. Evaluation of sinus venosus atrial-septal defect, OR; c. Kawasaki's disease, OR; d. Anomalous pulmonary venous drainage, OR; e. Suspected or known Marfan's syndrome, OR; f. Person scheduled or being evaluated for surgical repair of tetralogy of Fallot or other congenital heart disease, OR; g. Evaluation of other complex congenital heart diseases.

B. Relative Contraindications to Computed Tomography Angiography include the following: 1. Persons with allergy or intolerance to iodinated contrast material. The use of prednisone for contrast allergies is well known to radiology and cardiology groups who use contrast regularly 2. Persons with body mass index (BMI) greater than 50 3. Persons in whom there is an inability to image at desired heart rates (below 120 beats per minute) despite beta- blocker administration. 4. Persons with extensive coronary calcification by plain film or with prior Agatston (Calcium) score greater than 1,700.

C. Unless specific benefits are provided under the member’s contract, JHHC considers Computed Tomography Angiography experimental and investigational and not medically necessary for the following: 1. Screening of asymptomatic persons 2. Screening of persons high pre-test probability of coronary artery disease 3. Evaluation of stent occlusion or in-stent restenosis unless stents are located in the proximal coronary segments 4. For all other indications not addressed in this policy, as they do not meet Technology Evaluation Criteria (Refer to Definitions section).

D. Unless specific benefits are provided under the member’s contract, JHHC considers Computed Tomography Angiography using less than 64-slice scanners experimental and investigational for all other indications, as they do not meet Technology Evaluation Criteria (TEC). Refer to Definition section.

V. DEFINITIONS Technology Assessment: The systematic evaluation of the properties, effects and/or impacts of health technologies and interventions. It covers both the direct, intended consequences of technologies and interventions and their indirect, unintended consequences (World Health Organization, 2018).

Technology Evaluation Criteria (TEC): A service, device or supply must meet all of the following criteria:

1. The technology must have final approval from the appropriate government regulatory bodies for intended use 2. There must be sufficient scientific evidence-based studies to permit conclusions concerning the effect of the technology on health outcomes 3. The technology must improve the member's net health outcome 4. The technology must be as beneficial as any established alternatives 5. The improvement must be attainable outside the investigational setting

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 4 of 7 VI. BACKGROUND Computed Tomography Angiography (CTA) is an x-ray testing procedure that offers detailed imaging of vital organs and blood vessels. It is considered a non-invasive procedure with mechanically rotating gantries that are used to obtain slices, currently 64 or more simultaneously, to view the coronary arteries (Danciu, 2007). CTA is also referred to as Coronary Computed Tomography or Cardiac Computed Tomography.

The performance of CTA has been improved by increasing the number of slices that can be acquired simultaneously by increasing the number of detector rows (AHTA, 2006). As the number of slices that can be acquired simultaneously increases, the scanning time is shortened and the spatial resolution is increased. Initial cardiac CT imaging was conducted with four-slice detector CT.

According to Health Quality Ontario, computed tomography angiography using 64-slices has been shown in studies to have a high negative predictive value (93 to 100 percent), using conventional coronary angiography as the reference standard.

Over the past few years, substantial new data have arrived supporting the clinical utility of CTA. At the same time, radiation dose associated with CTA has significantly declined. Two major randomized controlled clinical trials have been conducted in patients with stable chest pain and low-intermediate pretest probability of coronary artery disease: PROMISE and SCOT- HEART (Douglas et al. 2015; SCOT-HEART investigators 2015). Both trials compared the outcome of patients randomized to the traditional approach of stress testing vs. an approach utilizing CTA. While the PROMISE trial was significantly underpowered to demonstrate differences between the groups (event rate was only 3% instead of the anticipated 8%), there was a 23% nonsignificant odds reduction for myocardial infarction with the CTA strategy (Bittencourt et al. 2016). Further analysis of PROMISE revealed superior risk stratification of CTA vs. stress testing, including identifying 87% of patients who suffered myocardial infarction or cardiovascular death at follow up vs. only 33% of these identified by stress testing (Hoffmann et al. 2017). The SCOT-HEART trial demonstrated a 44% lower incidence of myocardial infarction or death from coronary artery disease after 5 years (SCOT-HEART Investigators et al. 2018). Compared to nuclear stress testing, CTA was associated with lower average radiation dose (12 vs. 14 mSv) in the PROMISE trial (Douglas et al. 2015). Cost analyses of PROMISE revealed similar healthcare expenses after stress testing or CTA (Mark, Douglas, and Daniels 2016). These cost analyses, however, did not consider long-term cost savings from lower morbidity associated with the CTA strategy.

The described findings led to major changes in practice guidelines. The National Institute for Clinical Excellence in the UK updated its guidelines in November of 2016 to reflect the results from SCOT-HEART and now recommends CTA as the only first-line test in patients with stable typical or atypical chest pain in whom coronary artery disease cannot be excluded by history alone (NICE 2016). The European Society of Cardiology updated its practice guidelines in 2019 and recommends both CTA and stress testing as first line tests in patients with stable chest pain (class I recommendation) (Knuuti et al, 2019). This policy has been revised to reflect these changes.

Note: The following CPT/HCPCS codes are included below for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) below does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

Note: All inpatient admissions require preauthorization.

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 5 of 7

Compliance with the provision in this policy may be monitored and addressed through post payment data analysis and/or medical review audits Employer Health Programs Priority Partners (PPMCO) US Family Health Plan Advantage MD, LCD (EHP) refer to specific refer to COMAR guidelines (USFHP), TRICARE Medical and NCD Medical Policy Summary Plan Description and then apply the Medical Policy supersedes JHHC supersedes JHHC Medical (SPD). If there is no criteria Policy criteria. Medical Policy. If there is no Policy. If there is no LCD in the SPD, apply the Medical Policy in TRICARE, apply or NCD, apply the Medical Policy criteria. the Medical Policy Criteria. Policy Criteria.

VIII. CODING INFORMATION CPT CODES DESCRIPTION 75574 Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image post-processing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structures, if performed)

ICD10 CODES DESCRIPTION E08.00 - E09.9 Diabetes mellitus due to underlying conditions E10.10 - E13.9 Type I and Type II diabetes mellitus I37.0 - I37.9 Nonrheumatic pulmonary valve disorders M30.3 Mucocutaneous lymph node syndrome Q21.1 Atrial septal defect Q21.3 Tetralogy of Fallot Q26.0 - Q26.9 Congenital malformations of great veins Q87.40 - Q87.43 Marfan's Syndrome R07.1 - R07.9 Chest Pain R94.39 Abnormal result of other cardiovascular function study Z68.41 - Z68.45 Body mass index (BMI) 40 or greater, adult Z91.041 Radiologic dye allergy status

IX. REFERENCE STATEMENT Analyses of the scientific and clinical references cited below were conducted and utilized by the Johns Hopkins HealthCare LLC (JHHC) Medical Policy Team during the development and implementation of this medical policy. The Medical Policy Team will continue to monitor and review any newly published clinical evidence and revise the policy and adjust the references below accordingly if deemed necessary.

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 6 of 7 X. REFERENCES Aetna. (2019). Clinical Policy Bulletin: Cardiac CT, Coronary CT Angiography, Calcium Scoring and CT Fractional Flow Reserve. Medical Policy Number 0228. Retrieved: http://www.aetna.com/cpb/medical/data/200_299/0228.html

Amerigroup2020). Computed Tomography to Detect Coronary Artery Calcification. Medical Policy Number RAD00001. Retrieved: https://medicalpolicies.amerigroup.com/medicalpolicies/policies/mp_pw_a050531.htm

Berman, D.S., Shaw, L.J., Hachamovitch, R., et al. (2007). Comparative use of radionuclide stress testing, coronary artery calcium scanning and noninvasive coronary angiography for diagnostic and prognostic cardiac assessment. Seminars in Nuclear Medicine,37(1), 2-16.

Bittencourt, M. S., E. A. Hulten, V. L. Murthy, M. Cheezum, C. E. Rochitte, M. F. Di Carli, and R. Blankstein. 2016. "Clinical Outcomes After Evaluation of Stable Chest Pain by Coronary Computed Tomographic Angiography Versus Usual Care: A Meta-Analysis." Circulation.Cardiovascular Imaging 9 (4): e004419

CareFirst Medical Policy 6.01.035 (2019). Cardiac Computed Tomography (CT) and Coronary CT Angiography (CTA). Retrieved: https://provider.carefirst.com/providers/medical/medical-policy

Cigna. (2019). Computed Tomography Angiogram (CT Angiogram). Test Overview. Retrieved: https://www.cigna.com/ individuals-families/health-wellness/hw/medical-tests/computed-tomography-angiogram-bo1097

Cook, T.S., Galperin-Aizenberg, M., Litt, H.I. (2013). Coronary and Cardiac Computed Tomography in the Emergency Room: Current Status and Future Directions. Journal of Thoracic Imaging, Vol. 28(4), 201-16.

Danciu, S.C., Herrera, C.J., Stecy, P.J., et al. (2007). Usefulness of Multislice Computed Tomographic Coronary Angiography to Identify Patients with Abnormal Myocardial Perfusion Stress in Whom Diagnostic Catheterization May Be Safely Avoided. The American Journal of Cardiology, 100(11), 1605-1608.

Douglas, P. S., U. Hoffmann, M. R. Patel, D. B. Mark, H. Al-Khalidi, B. Cavanaugh, J. Cole, et al. 2015. "Outcomes of Anatomical Versus Functional Testing for Coronary Artery Disease." The New England Journal of Medicine 372 (14): 1291-1300. doi:10.1056/NEJMoa1415516 [doi]

eviCore (2020). Clinical Guidelines, Cardiology & Radiology. Retrieved: https://www.evicore.com/provider/clinical-guidelines

Galperin-Aizenberg, M., Cook, T.S., Hollander, J.E., Litt, H.I., (2015). Cardiac CT Angiography in the Emergency Department. American Journal of Roentgenology, 204(3).

Gerber, T.C., Gibbons, R.J. (2010). Weighing the Risks and Benefits of Cardiac Imaging with Ionizing Radiation. Journal of the American College of Cardiovascular Imaging. 3,528-535.

Hayes, Inc. (2011). Medical Technology Directory: Multislice Computed Tomography for Detection of Coronary Artery Disease. Retrieved: https://www.hayesinc.com

Health Quality Ontario. (2010). 64-Slice Computed Tomographic Angiography for the Diagnosis of Intermediate Risk Coronary Artery Disease: An Evidence-Based Analysis. Ontario Health Technology Assessment Series. 10(11), 1–44.

Hoffmann, U., M. Ferencik, J. E. Udelson, M. H. Picard, Q. A. Truong, M. R. Patel, M. Huang, et al. 2017. "Prognostic Value of Noninvasive Cardiovascular Testing in Patients with Stable Chest Pain: Insights from the PROMISE Trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain)." Circulation 135(24): 2320-2332.

Subject Revision Date 04/19/2020 Computed Tomography Angiography (CTA) Page 7 of 7 Kamperidis, V., de Graaf, M.A., Broersen, A., et al. (2014). Prognostic Value of Aortic and Mitral Valve Calcium Detected by Contrast Cardiac Computed Tomography Angiography in Patients with Suspicion of Coronary Artery Disease. The American Journal of Cardiology, 113(5),772-778

Knuuti, J., W. Wijns, A. Saraste, D. Capodanno, E. Barbato, C. Funck-Brentano, E. Prescott, et al. (2019). 2019 ESC Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes." European Heart Journal: pii: ehz425. doi:ehz425 [pii].

Mark, D. B., P. S. Douglas, and M. R. Daniels. 2016. "Economic Outcomes with Anatomical Versus Functional Diagnostic Testing for Coronary Artery Disease." Annals of Internal Medicine 165 (12): 891-0482. doi:10.7326/L16-0482 [doi].

Mowatt, G., Cummins, E., Waugh, N., et al. (2008). Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technology Assessments, 12(17).

National Institute for Clinical Excellence (NICE): Chest pain of recent onset: assessment and diagnosis. Clinical guideline. Published 24 March 2010; updated November 2. https://www.nice.org.uk/guidance/cg95

SCOT-HEART investigators. 2015. "CT Coronary Angiography in Patients with Suspected Angina due to Coronary Heart Disease (SCOT-HEART): An Open-Label, Parallel-Group, Multicentre Trial." Lancet 385: 2383-2391.

SCOT-HEART Investigators, D. E. Newby, P. D. Adamson, C. Berry, N. A. Boon, M. R. Dweck, M. Flather, et al. 2018. "Coronary CT Angiography and 5-Year Risk of Myocardial Infarction." The New England Journal of Medicine 379 (10): 924-933.

Taylor, A., Cerqueira, M., Hodgson, J., et al. (2010). Appropriate Use Criteria for Cardiac Computed Tomography: A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance. Journal of the American College of Cardiology, 56(22), 1864-1894.

TRICARE Policy Manual 6010.60-M. April 1, 2015. Diagnostic Radiology (Diagnostic Imaging), Chapter 5, Section 1.1. Retrieved: Tricare Policy Manuals

Wu, W., Pan, D.R., Foin, N., et al. (2016). Noninvasive fractional flow reserve derived from coronary computed tomography angiography for identification of ischemic lesions: a systematic review and meta-analysis. Scientific Reports, Epub.

XI. APPROVALS Historical Effective Dates: 03/03/2008, 03/02/2009, 06/04/2010, 01/10/2011, 04/15/2011, 05/29/2012, 09/05/2014, 09/02/2016, 08/21/2018, 08/03/2020