FOR CMS (MEDICARE) MEMBERS ONLY NATIONAL COVERAGE DETERMINATION (NCD) FOR COMPUTED TOMOGRAPHY:

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1 Natinal Imaging Assciates, Inc. Clinical guideline CT HEART CT HEART Cngenital (Nt including crnary arteries) Original Date: September 1997 Page 1 f 10 CPT Cdes: 75572, Last Reviewed Date: September 2014 NCD Last Effective Date: March 2008 Guideline Number: NIA_CG_025 Last Revised Date: February 2015 Respnsible Department: Clinical Operatins Implementatin Date: February 2015 FOR CMS (MEDICARE) MEMBERS ONLY NATIONAL COVERAGE DETERMINATION (NCD) FOR COMPUTED TOMOGRAPHY: Item/Service Descriptin A. General Diagnstic examinatins f the head (head scans) and f ther parts f the bdy (bdy scans) perfrmed by cmputerized tmgraphy (CT) scanners are cvered if medical and scientific literature and pinin supprt the effective use f a scan fr the cnditin, and the scan is: (1) reasnable and necessary fr the individual patient; and (2) perfrmed n a mdel f CT equipment that meets the criteria in C belw. CT scans have becme the primary diagnstic tl fr many cnditins and symptms. CT scanning used as the primary diagnstic tl can be cst effective because it can eliminate the need fr a series f ther tests, is nn-invasive and thus virtually eliminates cmplicatins, and des nt require hspitalizatin. Indicatins and Limitatins f Cverage fr NCD B. Determining Whether a CT Scan Is Reasnable and Necessary Sufficient infrmatin must be prvided with claims t differentiate CT scans frm ther radilgy services and t make cverage determinatins. Carefully review claims t insure that a scan is reasnable and necessary fr the individual patient; i.e., the use must be fund t be medically apprpriate cnsidering the patient's symptms and preliminary diagnsis. There is n general rule that requires ther diagnstic tests t be tried befre CT scanning is used. Hwever, in an individual case the cntractr's medical staff may determine that use f a CT scan as the initial diagnstic test was nt reasnable and necessary because it was nt supprted by the patient's symptms r cmplaints stated n the claim frm; e.g., "peridic headaches." Claims fr CT scans are reviewed fr evidence f abuse which might include the absence f reasnable indicatins fr the scans, an excessive number f scans r unnecessarily expensive types f scans cnsidering the facts in the particular cases. 1 NCD/NIA Heart CT & CT Cngenital Prprietary

2 NIA CLINICAL GUIDELINE FOR HEART CT AND HEART CT CONGENITAL: INTRODUCTION: Cardiac cmputed tmgraphy (Heart CT) can be used t image the cardiac chambers, valves, mycardium and pericardium t assess cardiac structure and functin. Applicatins f Heart CT listed and discussed in this guideline include: characterizatin f cngenital heart disease, characterizatin f cardiac masses, diagnsis f pericardial diseases, and preperative crnary vein mapping. The table belw crrelates and matches the clinical indicatins with the Apprpriate Use Scre based n a scale f 4 t 9, where the upper range (7 t 9) implies that the test is generally acceptable and is a reasnable apprach. The mid-range (4 t 6) indicates uncertainty in the apprpriateness f the test fr the clinical scenari. In all cases, additinal factrs shuld be taken int accunt including but nt limited t cst f test, impact f the image n clinical decisin making when cmbined with clinical judgment and risks, such as radiatin expsure and cntrast adverse effects, shuld be cnsidered. Where the Heart CT is the preferred test based upn the indicatin the Apprpriate Use Scre will be in the upper range such as nted with indicatin #51 assessment f right ventricular mrphlgy r suspected arrhythmgenic right ventricular dysplasia. Fr indicatins in which there are ne r mre alternative tests with an apprpriate use scre rating (apprpriate, uncertain) nted, fr example indicatin #52 (Assessment f mycardial viability, prir t mycardial revascularizatin fr ischemic left ventricular systlic dysfunctin and ther imaging mdalities are inadequate r cntraindicated), additinal factrs shuld be cnsidered when determining the preferred test (Stress Echcardigram if there are n cntra-indicatins). Where indicated as alternative tests, TTE (transthracic echcardigraphy) and SE (Stress echcardigraphy) are a better chice, where pssible, because f avidance f radiatin expsure. Heart MRI can be cnsidered as an alternative, especially in yung patients, where recurrent examinatins may be necessary. 2 NCD/NIA Heart CT & CT Cngenital Prprietary

3 INDICATIONS FOR HEART CT: T qualify fr cardiac cmputed tmgraphy, the patient must meet ACCF/ASNC Apprpriateness Use Scre (Apprpriate Use Scre 7 9 r Uncertain Apprpriate Use Scre 4-6). ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Apprpriate Use Criteria fr Cardiac (Heart) Cmputed Tmgraphy: ACCF et al. Criteria # Heart CT (Indicatin and Apprpriate Use Scre) A= Apprpriate; U=Uncertain 46 A (9) 47 A (8) 48 A (7) 50 A (7) 51 A (7) 52 U (5) INDICATIONS (*Refer t Additinal Infrmatin sectin) Evaluatin f Cardiac Structure and Functin Adult Cngenital Heart Disease Assessment f anmalies f crnary arterial and ther thracic arterivenus vessels ( fr anmalies f crnary arterial vessels CCTA preferred and fr ther thracic arterivenus vessels Heart CT preferred ) Further assessment f cmplex adult cngenital heart disease after cnfirmatin by TTE echcardigram Other imaging mdality crsswalk, TTE, Stress Ech (SE) and Heart MRI (ACCF et.al. Criteria # Indicatin with Apprpriate Use Scre TTE 92 and 94 A (9) Evaluatin f Ventricular Mrphlgy and Systlic Functin Evaluatin f left ventricular functin Fllwing acute MI r in HF patients Inadequate images frm ther nninvasive methds Quantitative evaluatin f right ventricular functin Assessment f right ventricular mrphlgy Suspected arrhythmgenic right ventricular dysplasia Assessment f mycardial viability Prir t mycardial revascularizatin fr ischemic left TTE 15 A(9) SE 176 A(8) 3 NCD/NIA Heart CT & CT Cngenital Prprietary

4 ACCF et al. Criteria # Heart CT (Indicatin and Apprpriate Use Scre) A= Apprpriate; U=Uncertain INDICATIONS (*Refer t Additinal Infrmatin sectin) ventricular systlic dysfunctin Other imaging mdalities are inadequate r cntraindicated Evaluatin f Intra- and Extracardiac Structures Characterizatin f native cardiac valves Suspected clinically significant 53 A (8) valvular dysfunctin Inadequate images frm ther nninvasive methds Characterizatin f prsthetic cardiac valves Suspected clinically significant 54 A (8) valvular dysfunctin Inadequate images frm ther nninvasive methds Evaluatin f cardiac mass (suspected tumr r thrmbus) 56 A (8) Inadequate images frm ther nninvasive methds 57 A (8) Evaluatin f pericardial anatmy 58 A (8) 59 A (8) 60 A (8) Evaluatin f pulmnary vein anatmy Prir t radifrequency ablatin fr atrial fibrillatin Nninvasive crnary vein mapping Prir t placement f biventricular pacemaker Lcalizatin f crnary bypass grafts and ther retrsternal anatmy Prir t preperative chest r cardiac surgery ( fr lcalizatin f crnary bypass grafts CCTA preferred and fr ther retrsternal anatmy Heart CT preferred ) Other imaging mdality crsswalk, TTE, Stress Ech (SE) and Heart MRI (ACCF et.al. Criteria # Indicatin with Apprpriate Use Scre Heart MRI 23 A(8) Heart MRI 23 A(8) Heart MRI 26 A(9) 4 NCD/NIA Heart CT & CT Cngenital Prprietary

5 Fr indicatins in which there are ne r mre alternative tests with an apprpriate use scre rating (apprpriate, uncertain) nted, (fr example indicatin #52) then additinal factrs shuld be cnsidered when determining the preferred test (Stress Echcardigram if there are n cntraindicatins). Indicatin #52 f Heart CT: Assessment f mycardial viability Prir t mycardial revascularizatin fr ischemic left ventricular systlic dysfunctin Other imaging mdalities are inadequate r cntraindicated General Cntraindicatins t the Stress Ech: Inability t exercise, Obesity with a BMI equal t r greater than 40 Stress echcardigraphy has been perfrmed hwever findings were inadequate, there were technical difficulties with interpretatin, r results were discrdant with previus clinical data. Arrhythmias with Stress Echcardigraphy - any patient n a type 1C antiarrhythmic drug (i.e. Flecainide r Prpafenne) r cnsidered fr treatment with a type 1C anti-arrhythmic drug. Fr all ther requests, the patient must meet ACCF/ASNC Apprpriateness criteria fr indicatins (scre 4-9) abve. INDICATIONS IN ACC GUIDELINES WITH INAPPROPRIATE DESIGNATION: Patient meets ACCF/ASNC Apprpriateness Use Scre fr inapprpriate indicatins (median scre 1-3) nted belw OR ne r mre f the fllwing: Fr same imaging tests less than six weeks apart unless specific guideline criteria states therwise. Fr different imaging tests, such as CT and MRI, f same anatmical structure less than six weeks apart withut high level review t evaluate fr medical necessity. Fr re-imaging f repeat r pr quality studies. Fr imaging f pediatric patients twelve years ld and yunger under prspective authrizatins. Cntraindicatins - There is insufficient data t supprt the rutine use f Heart CT fr the fllwing: As the first test in evaluating symptmatic patients (e.g. chest pain) T evaluate chest pain in an intermediate r high risk patient when a stress test (exercise treadmill, stress ech, MPI, cardiac MRI, cardiac PET) is clearly psitive r negative. Preperative assessment fr nn-cardiac, nnvascular surgery Preperative imaging prir t rbtic surgery (e.g. t visualize the entire arta) Evaluatin f left ventricular functin fllwing mycardial infarctin r in chrnic heart failure. 5 NCD/NIA Heart CT & CT Cngenital Prprietary

6 Mycardial perfusin and viability studies. Evaluatin f patients with pstperative native r prsthetic cardiac valves wh have technically limited echcardigrams, MRI r TEE. ADDITIONAL INFORMATION RELATED TO HEART CT: Abbreviatins ACS = acute crnary syndrme ARVC = arrhythmgenic cardimypathy ARVD = arrhythmgenic right ventricular dysplasia CABG = crnary artery bypass grafting surgery CAD = crnary artery disease CCS = crnary calcium scre CHD = crnary heart disease CT = cmputed tmgraphy CTA = cmputed tmgraphy angigraphy ECG = electrcardigram HF = heart failure MET = estimated metablic equivalent f exercise MI = mycardial infarctin MPI = Mycardial Perfusin Imaging r Nuclear Cardiac Imaging PCI = percutaneus crnary interventin SE = Stress Echcardigram TTE = Transthracic Echcardigraphy ECG Uninterpretable Refers t ECGs with resting ST-segment depressin ( 0.10 mv), cmplete LBBB, preexcitatin (Wlff-Parkinsn-White Syndrme), r paced rhythm. Acute Crnary Syndrme (ACS): Patients with an ACS include thse whse clinical presentatins cver the fllwing range f diagnses: unstable angina, mycardial infarctin withut ST-segment elevatin (NSTEMI), and mycardial infarctin with ST-segment elevatin (STEMI) *Pretest Prbability f CAD fr Symptmatic (Ischemic Equivalent) Patients: Typical Angina (Definite): Defined as 1) substernal chest pain r discmfrt that is 2) prvked by exertin r emtinal stress and 3) relieved by rest and/r nitrglycerin. Atypical Angina (Prbable): Chest pain r discmfrt that lacks 1 f the characteristics f definite r typical angina. Nnanginal Chest Pain: Chest pain r discmfrt that meets 1 r nne f the typical angina characteristics. Once the presence f symptms (Typical Angina/Atypical Angina/Nn angina chest pain/asymptmatic) is determined, the pretest prbabilities f CAD can be calculated frm the risk algrithms as fllws: 6 NCD/NIA Heart CT & CT Cngenital Prprietary

7 Age (Years) < >60 Gender Typical/Definite Angina Pectris Atypical/Prbabl e Angina Pectris Nnanginal Chest Pain Asymptmatic Men Intermediate Intermediate Lw Very lw Wmen Intermediate Very lw Very lw Very lw Men High Intermediate Intermediate Lw Wmen Intermediate Lw Very lw Very lw Men High Intermediate Intermediate Lw Wmen Intermediate Intermediate Lw Very lw Men High Intermediate Intermediate Lw Wmen High Intermediate Intermediate Lw Very lw: Less than 5% pretest prbability f CAD Lw: Less than 10% pretest prbability f CAD Intermediate: Between 10% and 90% pretest prbability f CAD High: Greater than 90% pretest prbability f CAD **Glbal CAD Risk: It is assumed that clinicians will use current standard methds f glbal risk assessment such as thse presented in the Natinal Heart, Lung, and Bld Institute reprt n Detectin, Evaluatin, and Treatment f High Bld Chlesterl in Adults (Adult Treatment Panel III [ATP III]) (18) r similar natinal guidelines. CAD risk refers t 10- year risk fr any hard cardiac event (e.g., mycardial infarctin r CAD death). Lw glbal CAD risk Defined by the age-specific risk level that is belw average. In general, lw risk will crrelate with a 10-year abslute CAD risk <10%. Hwever, in wmen and yunger men, lw risk may crrelate with 10-year abslute CAD risk <6%. Intermediate glbal CAD risk Defined by the age-specific risk level that is average. In general, mderate risk will crrelate with a 10-year abslute CAD risk range f 10% t 20%. Amng wmen and yunger age men, an expanded intermediate risk range f 6% t 20% may be apprpriate. High glbal CAD risk Defined by the age-specific risk level that is abve average. In general, high risk will crrelate with a 10-year abslute CAD risk f >20%. CAD equivalents (e.g., diabetes mellitus, peripheral arterial disease) can als define high risk. Periperative Clinical Risk Predictrs: Histry f ischemic heart disease Histry f cmpensated r prir heart failure Histry if cerebrvascular disease Diabetes mellitus (requiring insulin) Renal insufficiency (creatinine >2.0) 7 NCD/NIA Heart CT & CT Cngenital Prprietary

8 Surgical Risk Categries (As defined by the ACC/AHA Guideline Update fr Periperative Cardivascular Evaluatin f Nn-Cardiac Surgery) High-Risk Surgery cardiac death r MI greater than 5% Emergent majr peratins (particularly in the elderly), artic and peripheral vascular surgery, prlnged surgical prcedures assciated with large fluid shifts and/r bld lss. Intermediate-Risk Surgery cardiac death r MI = 1% t 5% Cartid endarterectmy, head and neck surgery, surgery f the chest r abdmen, rthpedic surgery, prstate surgery. Lw-Risk Surgery cardiac death r MI less than 1% Endscpic prcedures, superficial prcedures, cataract surgery, breast surgery. Request fr a fllw-up study - A fllw-up study may be needed t help evaluate a patient s prgress after treatment, prcedure, interventin r surgery. Dcumentatin requires a medical reasn that clearly indicates why additinal imaging is needed fr the type and area(s) requested. Echcardigraphy This study remains the best test fr initially examining children in the assessment f cngenital heart disease. Hwever, if findings are unclear r need cnfirmatin, CT is useful and can ften be perfrmed with nly mild sedatin because f the shrt acquisitin time. CT and Cngenital Heart Disease (CHD) Many mre children with cngenital heart disease (CHD) are surviving t adulthd, increasing the need fr specialized care and sphisticated imaging. Currently mre adults than children have CHD. CT prvides 3D anatmic relatinship f the bld vessels and chest wall, and depicts cardivascular anatmic structures. It is used in the evaluatin f cngenital heart disease in adults, e.g., ventricular septal defect and anmalies f the artic valve. CT is als used increasingly in the evaluatin f patients with chest pain, resulting in detectin f unsuspected cngenital heart disease. CT is useful in the evaluatin f children with CHD when findings frm echcardigraphy are unclear r need cnfirmatin. CT and Cardiac Masses CT is used t evaluate cardiac masses, describing their size, density and spatial relatinship t adjacent structures. Nearly all cardiac tumrs are metastases. Primary tumrs f the heart are rare and mst are benign. Cardiac myxma is the mst cmmn type f primary heart tumr in adults and usually develps in the left atrium. Characteristic features f myxmas that can be assessed accurately n CT include lcatin in the left atrium, lbulated margin, inhmgeneus cntent, and a CT attenuatin value lwer that that f bld. Echcardigraphy is the methd f chice fr the diagnsis f cardiac myxma; CT is used t evaluate a patient with suspected myxma befre surgery. Cardiac tumrs generally vary in their mrphlgy and CT assessment may be limited. MRI may be needed fr further evaluatin. CT and Pericardial Disease CT is used in the evaluatin f pericardial cnditins. Echcardigraphy is mst ften used in the initial examinatin f pericardial disease, but has disadvantages when cmpared with CT which prvides a larger field f view than echcardigraphy. CT als has superir sft-tissue cntrast and prvides anatmic delineatins enabling lcalizatin f pericardial masses. Cntrast-enhanced CT is sensitive 8 NCD/NIA Heart CT & CT Cngenital Prprietary

9 in differentiating restrictive cardimypathy frm cnstrictive pericarditis which is caused mst ften by cardiac surgery and radiatin therapy. CT can depict thickening and calcificatin f the pericardium, which alng with symptms f physilgic cnstrictin r restrictin, may indicate cnstrictive pericarditis. CT is als used in the evaluatin f pericardial masses which are ften detected initially with echcardigraphy. CT can accurately define the site and extent f masses, e.g., cysts, hematmas and neplasms. CT and Radifrequency Ablatin fr Atrial Fibrillatin Atrial fibrillatin, an abnrmal heart rhythm riginating in the atria, is the mst cmmn supraventricular arrhythmia in the United States and can be a cause f mrbidity. In patients with atrial fibrillatin, radifrequency ablatin is used t electrically discnnect the pulmnary veins frm the left atrium. Prir t this prcedure, CT may be used t define the pulmnary venus anatmy which is cmmnly variable. Determinatin f hw many pulmnary veins are present and their stial lcatins is imprtant t make sure that all the stia are ablated. 9 NCD/NIA Heart CT & CT Cngenital Prprietary

10 REFERENCES ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Apprpriate Use Criteria fr Cardiac Cmputed Tmgraphy: A Reprt f the American Cllege f Cardilgy Fundatin Apprpriate Use Criteria Task Frce, the Sciety f Cardivascular Cmputed Tmgraphy, the American Cllege f Radilgy, the American Heart Assciatin, the American Sciety f Echcardigraphy, the American Sciety f Nuclear Cardilgy, the Nrth American Sciety fr Cardivascular Imaging, the Sciety fr Cardivascular Angigraphy and Interventins, and the Sciety fr Cardivascular Magnetic Resnance. J. Am. Cll. Cardil. 56, Retrieved frm ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011 Apprpriate Use Criteria fr Echcardigraphy. A Reprt f the American Cllege f Cardilgy Fundatin Apprpriate Use Criteria Task Frce, American Sciety f Echcardigraphy, American Heart Assciatin, American Sciety f Nuclear Cardilgy, Heart Failure Sciety f America, Heart Rhythm Sciety, Sciety fr Cardivascular Angigraphy and Interventins, Sciety f Critical Care Medicine, Sciety f Cardivascular Cmputed Tmgraphy, and Sciety fr Cardivascular Magnetic Resnance. Endrsed by the American Cllege f Chest Physicians. J Am Cll Cardil. Retrieved frm ACC/AHA/AATS/PCNA/SCAI/STS 2014 Fcused Update f the Guideline fr the Diagnsis and Management f Patients With Stable Ischemic Heart DiseaseA Reprt f the American Cllege f Cardilgy/American Heart Assciatin Task Frce n Practice Guidelines, and the American Assciatin fr Thracic Surgery, Preventive Cardivascular Nurses Assciatin, Sciety fr Cardivascular Angigraphy and Interventins, and Sciety f Thracic Surgens. Jurnal f the American Cllege f Cardilgy, 2014, 7, di: /j.jacc Retrieved frm ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2013 Multimdality Apprpriate Use Criteria fr the Detectin and Risk Assessment f Stable Ischemic Heart DiseaseA Reprt f the American Cllege f Cardilgy Fundatin Apprpriate Use Criteria Task Frce, American Heart Assciatin, American Sciety f Echcardigraphy, American Sciety f Nuclear Cardilgy, Heart Failure Sciety f America, Heart Rhythm Sciety, Sciety fr Cardivascular Angigraphy and Interventins, Sciety f Cardivascular Cmputed Tmgraphy, Sciety fr Cardivascular Magnetic Resnance, and Sciety f Thracic Surgens. Jurnal f the American Cllege f Cardilgy, 2014, 63(4), di: /j.jacc Retrieved frm American Cllege f Radilgy. (2014). ACR Apprpriateness Criteria Retrieved frm Crnin, P., Sneider, M. B., Kazerni, E.A., Kelly, A. M., Scharf, C., Oral, H., & Mrady, F. (2004, September). MDCT f the left atrium and pulmnary veins in planning 10 NCD/NIA Heart CT & CT Cngenital Prprietary

11 radifrequency ablatin fr atrial fibrillatin: a hw-t guide. Am J Rentgenl, 183(3), Retrieved frm Einstein, A. (2012). Effects f radiatin expsure frm cardiac imaging: hw gd are the data? Jurnal f the American Cllege f Cardilgy, 59(6), Retrieved frm Frauenfelder, T., Appenzeller, P., Karl, C., Scheffel, H., Desbilles, L., Stlzmann, P.,... Schertier, T. (2011). Triple rule-ut CT in the emergency department: prtcls and spectrum f imaging findings. Eurpean Radilgy, 19(4), Retrieved frm Jngbled, M. R., Dirksen, M.S., Bax, J. J., Bersma, E., Geleijns, K., Lamb, H. J.,... Schalij, M. J. (2005, March). Atrial fibrillatin: Multi-detectr rw CT f pulmnary vein anatmy prir t radifrequency catheter ablatin--initial experience. Radilgy, 234(3), Retrieved frm Naplitan, G., Pressacc, J., & Paquet, E. (2009, February). Imaging features f cnstrictive pericarditis: beynd pericardial thickening. Canadian Assciatin f Radilgists Jurnal, 60(1), Retrieved frm Schenhagen, P., Halliburtn, S. S., Stillman, A. R., & White, R. D. (2005, February). CT f the heart: principles, advances, clinical uses. Cleveland Clinic Jurnal f Medicine, 72(2), Retrieved frm Sctt-Mncrieff, A., Yang, J., Levine, D., Taylr, C., Ts, D., Jhnsn, M.,... Leipsic, J. (2011). Real-wrld estimated effective radiatin dses frm cmmnly used cardiac testing and prcedural mdalities. The Canadian Jurnal f Cardilgy, 27(5), Retrieved frm timated_effective_radiatin_dses_frm_cmmnly_used_cardiac_testing_and_prcedur al_mdalities_ Tatli, S., & Liptn, M. J. (2005, February). CT fr intracardiac thrmbi and tumrs. Internatinal Jurnal f Cardivascular Imaging, 21(1), di: /s x. Techasith, T., & Cury, R. (2011). Stress mycardial CT perfusin: an update and future perspective. JACC. Cardivascular Imaging, 4(8), Retrieved frm Van de Veire, N. R., Schuijf, J. D., De Sutter, J., Devs, D., Bleeker, G. B., de Rs, A., Bax, J. J. (2006, Nv). Nn-invasive visualizatin f the cardiac venus system in crnary artery disease patients using 64-slice cmputed tmgraphy. Jurnal f the American Cllege f Cardilgy, 48(9), Retreived frm di.rg/ /j.jacc NCD/NIA Heart CT & CT Cngenital Prprietary

12 Wang, Z. J., Reddy, G., Gtway, M. B., Yeh, B. M., Hetts, S. W., & Higgins, C. B. (2003, Octber). CT and MR imaging f pericardial disease. Radigraphics, 23, S167-S180. Retrieved frm Wiant, A., Nyberg, E., Gilkesn, R. C. (2009, August). CT evaluatin f cngenital heart disease in adults. Am J Rentgenl, 193(2), Retrieved frm 12 NCD/NIA Heart CT & CT Cngenital Prprietary