Clinical Policy Bulletin: Color-Flow Doppler Echocardiography in Adults

Transcription

1 : Go Clinical Policy Bulletin: Color-Flow Doppler Echocardiography in Adults Number: 0008 Policy *Pleasesee amendment forpennsylvaniamedicaidattheendofthiscpb. Additional Information I. Aetna considers color-flow Doppler echocardiography in adults medically necessary for the following indications: Evaluation of aortic diseases Evaluation of aortocoronary bypass grafts Evaluation of hypertrophic cardiomyopathy (formerly known as idiopathic hypertrophic subaortic stenosis) Evaluation of prosthetic valves Evaluation of septal defects Evaluation of site of left-to-right or right-to-left shunts Evaluation of the severity of valve stenosis and regurgitation II. Aetna considers color-flow Doppler echocardiography in adults experimental and investigational for all other indications (e.g., to guide catheter ablation in ventricular tachycardia) because its effectiveness for these indications has not been established. CPB Fetal Echocardiography and Magnetocardiography, and CPB Intravascular Ultrasound. Background This policy is based on guidelines on diagnostic echocardiography in adults from the American College of Cardiology (Cheitlin et al, 2003). Echocardiography is an ultrasound technique for diagnosing cardiovascular disorders. It is subdivided into M-mode, two-dimensional (2-D), spectral Doppler, color Doppler, contrast, and stress echocardiography (Beers and Berkow, 1999). Echocardiography is usually performed by placing a transducer over the chest. In transesophageal echocardiography, however, the transducer is placed at the tip of an endoscope that is inserted into the esophagus (Beers and Berkow, 1999). Even smaller transducers can be placed on intravascular catheters, permitting intravascular recordings of vessel anatomy and blood flow.

2 Two-dimensional (or cross-sectional) echocardiography is the dominant echocardiographic technique (Beers and Berkow, 1999; Gottdiener et al, 2004). It uses pulsed, reflected ultrasound to provide spatially correct real time tomographic images of the heart, which are recorded on videotape and resemble cineangiograms. Two-dimensional echocardiography provides information about the cardiac chamber size, wall thickness, global and regional systolic function, and valvular and vascular structures. B-mode imaging refers to cross-sectional 2-D images displayed without motion, and provides detail of static structures. M-mode (or motion-mode) echocardiography creates a continuous 1-D graphic display, and is useful for measuring single dimensions of walls and chambers of the heart, which can be used to estimate chamber volumes and left ventricular mass (Beers and Berkow, 1999; Gottdiener et al, 2004). M-mode echocardiography is performed by directing a stationary pulsed ultrasound beam at some portion of the heart. The Doppler technique uses reflections from moving red blood cells to characterize blood flow (Beers and Berkow, 1999; Gottdiener et al, 2004). Spectral Doppler echocardiography uses ultrasound to record the velocity, direction, and type of blood flow in the cardiovascular system. The spectral Doppler signal is displayed on a strip chart recorder or videotape. Stress echocardiography uses any combination of the above echocardiography modalities, before and during (or shortly after) a physical or pharmacological stress intervention (Beers and Berkow, 1999; Gottdiener et al, 2004). Most commonly, a treadmill or exercise bicycle is used for stress echocardiography. In patients who are unable to exercise, stress testing can be performed with pharmacological agents, such as dobutamine, that increased myocardial oxygen demand, or vasodilators that produce coronary steal. These tests have utility primarily in the detection of myocardial ischemia and viability. Contrast echocardiography is an M-mode or 2-D echocardiographic examination during which contrast agents are administered via venous injection (Beers and Berkow, 1999; Gottdiener et al, 2004). Venous contrast injections are used to enhance left ventricular endocardial borders and Doppler signals and to assess myocardial perfusion. Color Doppler echocardiography is essentially 2-D Doppler echocardiography with flow encoded in color to show its direction (red is toward and blue is away from the transducer) (Beers and Berkow, 1999; Gottdiener et al, 2004). In color flow mapping, blood flow velocity is measured along each sector line of a 2-D echocardiographic image and is displayed as color coded pixels. Color flow Doppler is most useful for assessing valves for regurgitation and stenosis, detecting the presence of intracardiac shunts, and imaging blood flow in the heart. Evidence-based guidelines from the American College of Cardiology, American Heart Association, and American Society of Echocardiography (Antman et al, 2003) outlined the accepted capabilities for Doppler echocardiography in the adult patient. Specific indications were classified as relating to "anatomy-pathology" or to "function", and each potential indication was rated from "most helpful" to "not useful." Among indications related to anatomy-pathology, color Doppler was rated as most helpful for evaluating septal defects (Antman et al, 2003). Color Doppler was considered not useful for all other indications related to anatomy-pathology: evaluation of chamber size, thickness of walls, relation of chambers, early closure of mitral valve, systolic anterior motion of mitral valve, left ventricular mass, left ventricular masses (tumor, clot, vegetation), masses in atria and right ventricle, anatomic valvular pathology, and pericardial effusion. Among functional indications, color Doppler was considered most useful for evaluating the site of rightto-left and left-to-right shunts (Antman et al, 2003). Color Doppler was also considered useful for evaluating severity of valve stenosis and valve regurgitation and evaluation of prosthetic valves. Color Doppler was also considered to be of some use in evaluating aortic diseases. Color Doppler was

3 considered not useful for assessment of global left ventricular systolic function (ejection fraction), evaluation of regional wall motion, measurement of right ventricular and pulmonary artery systolic pressures, measurement of left ventricular filling pressure, measurement of stroke volume and cardiac output, assessment of left ventricular diastolic function, and identifying ischemia and viable myocardium with exercise or pharmacological stress. Nishimura et al (2011) examined the significance of measurement of stenosis by aliasing coronary flow (the MOSAIC method) for the detection of proximal left coronary stenosis in patients with unstable angina (UA) by means of transthoracic Doppler echocardiography. Patients (n = 107) with UA were evaluated. Proximal left coronary flow was sought in the short axis at the aortic root level using color Doppler guidance. When detected coronary flow showed color aliasing, the color velocity range was gradually increased until color aliasing nearly disappeared. Then, the color baseline was shifted until the color flow showed "isovelocity". Proximal coronary flow was detected in 86 (80.4 %) of 107 patients. In these 86 patients, an optimal cut-off value of isovelocity greater than or equal to 47.5 cm/second predicted significant coronary stenosis (percent diameter stenosis greater than or equal to 70 %) of the proximal left anterior descending (American Heart Association segment 6) or left main coronary artery with a sensitivity of 88 %, specificity of 97 %, positive predictive value of 98 %, and negative predictive value of 86 %. In all 107 patients, the same cut-off value predicted significant coronary stenosis with a sensitivity of 78 %, specificity of 98 %, positive predictive value of 98 %, and negative predictive value of 81 %. The authors concluded that the MOSAIC method may play a complementary role in expeditious risk stratification and decision making in patients with UA. The American College of Radiology's Expert Panel on Cardiovascular Imaging (Ho et al, 2011) states that echocardiography using color flow Doppler is essential for evaluating blood flow as seen across an atrial defect or a ventricular septal defect or across a valve. Assessment of the valves (sclerosis, fusion, estimation of valve gradients) and determination of right ventricular systolic pressure can usually be achieved. An UpToDate review on "Catheter ablation for ventricular arrhythmias" (Ganz, 2012) states that " [i]ntracardiac echocardiography (ICE) with 2D and Doppler color flow imaging may be useful to guide mapping and ablation catheters and monitor morphologic changes after ablation". The reference cited was the study by Ren et al (2002) that comprised only 4 patients with ventricular tachycardia. Thus, there is currently insufficient evidence to support the use of color-flow Doppler echocardiography during ventricular tachycardia ablation. An UpToDate review on Principles of Doppler echocardiography (Manning, 2013) states that Color flow imaging is typically used in the screening and assessment of regurgitant flows. It is also useful in the assessment of intracardiac shunts (e.g., atrial and ventricular septal defects) and pulmonary vein flow, and to assist in continuous wave Doppler alignment for tricuspid regurgitation velocities. Appendix Note on documentation requirements: Physicians are reminded to bill the findings of the diagnostic test as the primary indication rather than the referring physician s diagnosis, as indicated by Medicare s Diagnostic Imaging Billing guidelines. These guidelines are available in the Medicare Claims Processing Manual, Chapter 13 - Radiology Services and Other Diagnostic Procedures (revised November 2016). This is also indicated in the ICD-9-CM Coding Guidelines, Section IV, Paragraph L. CPT Codes / HCPCS Codes / ICD-10 Codes Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

4 CPT codes covered if selection criteria are met: Doppler echocardiography color flow velocity mapping (List separately in addition to codes for echocardiography) Other CPT codes related to the CPB [parent codes for 93325]: Echocardiography, fetal, cardiovascular system, real time with image documentation (2D), with or without M-mode recording; follow-up or repeat study Doppler echocardiography, fetal, pulsed wave and/or continuous wave with spectral display; complete follow-up or repeat study Transthoracic echocardiography for congenital cardiac anomalies; complete follow-up or repeat study Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, follow-up or limited study Echocardiography, transesophageal, real time with image documentation (2D) (with or without M-mode recording); including probe placement, image acquisition, interpretation and report image acquisition, interpretation and report only Transesophageal echocardiography for congenital cardiac anomalies; including probe placement, image acquisition, interpretation and report image acquisition, interpretation and report only Doppler echocardiography, pulsed wave and/or continuous wave with spectral display (List separately in addition to codes for echocardiographic imaging); complete follow-up or limited study (List separately in addition to codes for echocardiographic imaging) Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report including performance of continuous electrocardiographic monitoring, with physician supervision Intracardiac catheter ablation of atrioventricular node function, atrioventricular conduction for creation of complete heart block, with or without temporary pacemaker placement [experimental and investigational to guide catheter ablation procedures in ventricular tachycardia] Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right

5 ventricular pacing and recording (when necessary), and His bundle recording (when necessary) with intracardiac catheter ablation of arrhythmogenic focus; with treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entry [experimental and investigational to guide catheter ablation procedures in ventricular tachycardia] Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording (when necessary), and His bundle recording (when necessary) with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricular ectopy including intracardiac electrophysiologic 3D mapping, when performed, and left ventricular pacing and recording, when performed [experimental and investigational to guide catheter ablation procedures in ventricular tachycardia] Other HCPCS codes related to the CPB:: C1886 Catheter, extravascular tissue ablation, any modality (insertable) [experimental and investigational to guide catheter ablation procedures in ventricular tachycardia] ICD-10 codes covered if selection criteria are met: A A40.9 Streptococcal sepsis A A41.02 Sepsis due to staphylococcus aureus A A41.2 Sepsis due to other specified and unspecified staphylococcus A41.3 Sepsis due to Hemophilus influenzae A41.4 Sepsis due to anaerobes A41.50 Gram-negative sepsis, unspecified A41.51 Sepsis due to Escherichia coli [E. coli] A41.52 Septicemia due to Pseudomonas A41.53 Sepsis due to Serratia A52.03 Syphilitic endocarditis A54.83 Gonococcal heart infection B39.4 (must be billed with I32) B39.4 (must be billed with I39) Histoplasmosis capsulati (pericarditis) Histoplasmosis capsulati (endocarditis) I01.1 Acute rheumatic endocarditis I01.2 Acute rheumatic myocarditis I01.8 Other acute rheumatic heart disease I01.9 Acute rheumatic heart disease, unspecified

6 I02.0 Rheumatic chorea with heart involvement I I05.9 Diseases of mitral valve I I06.9 Diseases of aortic valve I I07.9 Rheumatic tricuspid valve diseases I08.0 Rheumatic disorders of both mitral and aortic valves I I09.89 Other rheumatic heart disease I I22.9 Acute myocardial infarction I21.A1 Myocardial infarction type 2 I21.A9 Other myocardial infarction type I25.3 Aneurysm of heart I26.09 Acute cor pulmonale I I33.9 Acute and subacute endocarditis I Nonrheumatic mitral valve disorders [valve regurgitation] I I35.9 Nonrheumatic aortic valve disorders [valve regurgitation] I I36.9 Nonrheumatic tricuspid valve disorders [valve regurgitation] I38 - I39 Endocarditis and heart valve disorders I I40.9 Acute myocarditis I I43 Cardiomyopathy I I48.1 Atrial fibrillation and flutter I50.9 Heart failure, unspecified I51.0 Cardiac septal defect, acquired I51.1 Rupture of chordae tendineae, not elsewhere classified I51.2 Rupture of papillary muscle, not elsewhere classified I51.4 Myocarditis, unspecified I51.7 Cardiomegaly I51.81 Takotsubo syndrome I51.89 Other ill-defined heart diseases I I71.9 Aortic aneurysm and dissection I I95.9 Hypotension J81.0 Acute pulmonary edema M31.4 Aortic arch syndrome [Takayasu]

7 O O24.019, O O O O24.319, O O O O O33.6xx+ O35.0xx+ O35.1xx+ O35.2xx+ O35.3xx+ O35.4xx+ O35.5xx+ O35.8xx+ O35.9xx+ O O O O O40.1xx+ - O40.9xx+ O O O76 O O O O O O Diabetes mellitus in pregnancy Maternal care for disproportion due to hydrocephalic fetus Maternal care for (suspected) central nervous system malformation in fetus Maternal care for (suspected) chromosomal abnormality in fetus Maternal care for (suspected) hereditary disease in fetus Maternal care for (suspected) damage to fetus from viral disease in mother Maternal care for (suspected) damage to fetus from alcohol Maternal care for (suspected) damage to fetus by drugs Maternal care for other (suspected) fetal abnormality and damage Maternal care for (suspected) fetal abnormality and damage, unspecified Maternal care for rhesus isoimmunizations Maternal care for other isoimmunization Polyhydramnios Fetomaternal placental transfusion syndrome Abnormality in fetal heart rate and rhythm complicating labor and delivery Other viral diseases complicating pregnancy Other maternal infectious and parasitic diseases complicating pregnancy, childbirth and the puerperium Unspecified maternal infectious and parasitic diseases complicating pregnancy O O99.43 Diseases of the circulatory system complicating pregnancy, childbirth and puerperium P02.3 Newborn (suspected to be) affected by placental transfusion syndrome P Newborn affected by abnormality in fetal (intrauterine) heart rate or rhythm before the onset of labor P Newborn affected by abnormality in fetal (intrauterine) heart rate or rhythm,

8 unspecified as to time of onset P04.1 Newborn affected by other maternal medication P04.3 Newborn affected by maternal use of alcohol P P29.38 Persistent fetal circulation P P70.1 Syndrome of infant of mother with diabetes/gestational diabetes P83.2 Hydrops fetalis not due to hemolytic disease Q Q21.9 Congenital malformations of cardiac chambers, connections and septa Q Q22.3 Congenital malformations of pulmonary valves Q22.4 Congenital tricuspid stenosis Q22.5 Ebstein's anomaly Q23.0 Congenital stenosis of aortic valve Q23.1 Congenital insufficiency of aortic valve Q23.2 Congenital mitral stenosis Q23.3 Congenital mitral insufficiency Q23.4 Hypoplastic left heart syndrome Q24.2 Cor triatriatum Q24.3 Pulmonary infundibular stenosis Q24.4 Congenital subaortic stenosis Q24.8 Other specified congenital malformations of heart Q Q26.9 Congenital malformations of great veins Q86.0 Fetal alcohol syndrome (dysmorphic) Q Q87.43 Marfan's syndrome R01.1 Cardiac murmur, unspecified T82.01x+ - T82.09x+ T T T82.6xx+, T82.7xx+ T T82.9xx+ Mechanical complication of heart valve prosthesis Mechanical complication of coronary bypass graft Infection and inflammatory reaction due to cardiac valve prosthesis, vascular devices, implants, and grafts Other complications due to heart valve prosthesis T T Complications of heart transplant Z87.74 Personal history of (corrected) congenital malformations of heart and circulatory system

9 Z95.1 Presence of aortocoronary bypass graft Z95.2 Presence of prosthetic heart valve Z95.3 Presence of xenogenic heart valve ICD-10 codes not covered for indications listed in the CPB: I47.2 Ventricular tachycardia The above policy is based on the following references: 1. Antman EM, Smith SC, Alpert JS, et al. ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of Echocardiography. ACC/AHA Practice Guidelines. Dallas, TX: American Heart Association; Available at: Accessed March 5, Gottdiener JS, Bednarz J, Devereix R, et al. American Society of Echocardiography recommendations for use of echocardiography in clinical trials. A report from the American Society of Echocardiography s Guidelines and Standards Committee and the Task Force on Echocardiography in Clinical Trials. American Society of Echocardiography Report. J Am Soc Echocardiography. 2004;17(10): Beers MH, Berkow R, eds. Diagnostic cardiovascular procedures. In: The Merck Manual of Diagnosis and Therapy. 17th ed. Whitehouse Station, NJ: Merck & Co.; Pinheiro AC, Mancuso FJ, Hemerly DF, et al. Diagnostic value of color flow mapping and Doppler echocardiography in the quantification of mitral regurgitation in patients with mitral valve prolapse or rheumatic heart disease. J Am Soc Echocardiogr. 2007;20(10): Nishimura K, Okayama H, Inoue K, et al. Usefulness of the MOSAIC (measurement of stenosis by aliasing coronary flow) method using transthoracic color Doppler echocardiography in unstable angina patients. Int J Cardiol. 2011;151(2): Ho VB, Biko DM, White RD, et al, Expert Panel on Cardiovascular Imaging. Known or suspected congenital heart disease in the adult. ACR Appropriateness Criteria [online publication]. Reston, VA: American College of Radiology (ACR); Ren JF, Marchlinski FE, Callans DJ, Herrmann HC. Clinical use of AcuNav diagnostic ultrasound catheter imaging during left heart radiofrequency ablation and transcatheter closure procedures. J Am Soc Echocardiogr. 2002;15(10 Pt 2): Ganz LI. Catheter ablation for ventricular arrhythmias. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed September Manning WJ. Principles of Doppler echocardiography. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed September Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual. Chapter 13: Radiology Services and Other Diagnostic Procedures. Baltimore, MD: CMS; revised November 10, Available at: Guidance/Guidance/Manuals/downloads/clm104c13.pdf. Accessed August 7, 2017.

10 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. CPT only copyright 2015 American Medical Association. All Rights Reserved. Copyright Aetna Inc.Web Privacy Statement Legal Statement Privacy Notices Member Disclosure

11 AETNA BETTER HEALTH OF PENNSYLVANIA Amendment to Aetna Clinical Policy Bulletin Number: 0008 Color-Flow Doppler Echocardiography in Adults There are no amendments for Medicaid. new 05/01/2018