Original Date: July 1999 HEART (Cardiac) PET

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1 Magellan Healthcare Clinical guidelines Original Date: July 1999 HEART (Cardiac) PET Page 1 f 10 CPT Cdes: 78459, 78491, 78492, +0482T Last Reviewed Date: March, 2017 Guideline Number: NIA_CG_072 Last Revised Date: March, 2017 Respnsible Department: Clinical Operatins Implementatin Date: January 2018 INTRODUCTION: Cardiac PET has tw majr clinical uses. First, it can characterize mycardial bld flw (perfusin scan). The FDA has apprved bth rubidium-82 (Rb-82) and nitrgen-13(n-13) raditracers fr this purpse. Secnd, PET can identify regins f mycardial viability that appear scarred (dead) n standard rest r stress SPECT/MPI imaging. The FDA has apprved use f flurine 18 (F-18) flurdexyglucse fr this purpse. Initial Clinical Reviewers (ICRs) and Physician Clinical Reviewers (PCRs) must be able t apply criteria based n individual needs and based n an assessment f the lcal delivery system. INDICATIONS FOR CARDIAC PET SCAN WITH APPROVED FDA RADIOISOTOPES: Evaluatin f mycardial viability prir t pssible percutaneus r surgical revascularizatin if: Previus SPECT/MPI imaging fr viability is inadequate; AND Patient has severe left ventricular dysfunctin (LVEF 35%). Evaluatin in patient with suspected r knwn Crnary Artery Disease. T qualify fr PET perfusin scan dne either at rest r with pharmaclgic stress, the patient must meet criteria fr indicated nuclear cardiac imaging/mycardial perfusin study AND is likely t experience attenuatin artifact with SPECT imaging due t factrs such as mrbid besity, large breasts, breast implants, previus mastectmy, chest wall defrmity, pleural/pericardial effusin; OR Patient had a previus inadequate SPECT/MPI imaging due t inadequate findings, technical difficulties with interpretatin, r discrdant results with previus clinical data. Fr the diagnsis f suspected cardiac invlvement in patients with sarcidsis as evidenced by reduced heart functin n transthracic echcardigram r heart blck n baseline electrcardigram Fr patients wh have a cntraindicatin t MRI r wh have had an MRI f the heart with results equivcal fr sarcid invlvement. Examples f patients wh are unable t underg MRI include, but are nt limited t, patients with a pacemaker, autmatic implanted cardiverter-defibrillatr (AICDs), r ther metal implant. 1 Heart PET Scan 2018 v2 Prprietary

2 ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM Based APPROPRIATE USE CRITERIA fr PET Nuclear Cardiac Imaging / Mycardial Perfusin Study, including updates thrugh September, 2017 ACCF et al. Criteria # MPI / Stress Ech 2 / 115 INDICATIONS (*Refer t Additinal Infrmatin sectin) cntraindicatins as nted in sectin Indicatins fr a Nuclear Cardiac Imaging / Mycardial Perfusin Study. Please see explanatin in Intrductin, paragraph 6 Detectin f CAD/Risk Assessment: Symptmatic Evaluatin f Ischemic Equivalent (Nn-Acute) Lw pretest prbability f CAD * ECG uninterpretable OR unable t exercise APPROPRIATE USE SCORE (4-9); A= Apprpriate; U=Uncertain (MPI / Stress Ech) A(7) / A(7) 3 / 116 Intermediate pretest prbability f CAD* ECG interpretable AND able t exercise A(7) / A(7) 4 / / / 126 Intermediate pretest prbability f CAD* ECG uninterpretable OR unable t exercise A(9) / A(9) High pretest prbability f CAD* A(8) / A(7) Regardless f ECG interpretability and ability t exercise Detectin f CAD: Asymptmatic (Withut Ischemic Equivalent) Asymptmatic Intermediate CHD risk (ATP III risk criteria) *** U(5) / U(5) ECG uninterpretable 15 /127 High CHD risk (ATP III risk criteria) *** A(8) / U(5) 16 /128 New-Onset r Newly Diagnsed Heart Failure With LV Systlic Dysfunctin Withut Ischemic Equivalent N prir CAD evaluatin AND n planned crnary angigraphy A(8) / A(7) New-Onset Atrial Fibrillatin 17 / 132 Part f evaluatin when etilgy unclear U(6) / U(6) Ventricular Tachycardia 18 / NA Lw CHD risk (ATP III risk criteria) *** A(7) / NA 19 / NA Intermediate r high CHD risk (ATP III risk criteria) *** Syncpe 21 / 134 Intermediate r high CHD risk (ATP III risk criteria) *** A(8) / NA A(7) / A(7) 2 Heart PET Scan 2018 v2 Prprietary

3 ACCF et al. Criteria # MPI / Stress Ech INDICATIONS (*Refer t Additinal Infrmatin sectin) cntraindicatins as nted in sectin Indicatins fr a Nuclear Cardiac Imaging / Mycardial Perfusin Study. Please see explanatin in Intrductin, paragraph 6 Elevated Trpnin APPROPRIATE USE SCORE (4-9); A= Apprpriate; U=Uncertain (MPI / Stress Ech) 22 / 135 Trpnin elevatin withut additinal evidence A(7) / A(7) f acute crnary syndrme (with ischemia is nt subject t Stress Echcardigram cntraindicatins) Risk Assessment With Prir Test Results and/r Knwn Chrnic Stable CAD Asymptmatic OR Stable Symptms Nrmal Prir Stress Imaging Study 26 / 145 Intermediate t high CHD risk (ATP III risk U(6) / U(4) criteria) *** Last stress imaging study dne mre than r equal t 2 years ag If knwn CAD, nt subject t Stress Ech cntraindicatins Asymptmatic OR Stable Symptms Abnrmal Crnary Angigraphy OR Abnrmal Prir Stress Imaging Study, N Prir Revascularizatin 28 / 147 Knwn CAD n crnary angigraphy OR prir abnrmal stress imaging study Last stress imaging study dne mre than r equal t 2 years ag Prir Nninvasive Evaluatin 29 / 153 Equivcal, brderline, r discrdant stress testing where bstructive CAD remains a cncern New r Wrsening Symptms 30 / 151 Abnrmal crnary angigraphy OR abnrmal prir stress imaging study 31 / 152 Nrmal crnary angigraphy OR nrmal prir stress imaging study Crnary Angigraphy (Invasive r Nninvasive) 32 / 141 Crnary stensis r anatmic abnrmality f uncertain significance Asymptmatic Prir Crnary Calcium Agatstn Scre U(5) / U(5) A(8) / A(8) A(9) / A(7) U(6) / U(5) A(9) / A(8) 3 Heart PET Scan 2018 v2 Prprietary

4 ACCF et al. Criteria # MPI / Stress Ech INDICATIONS (*Refer t Additinal Infrmatin sectin) cntraindicatins as nted in sectin Indicatins fr a Nuclear Cardiac Imaging / Mycardial Perfusin Study. Please see explanatin in Intrductin, paragraph 6 34 / 137 Lw t intermediate CHD risk *** Agatstn scre between 100 and / 138 High CHD risk *** Agatstn scre between 100 and 400 APPROPRIATE USE SCORE (4-9); A= Apprpriate; U=Uncertain (MPI / Stress Ech) U(5) / U(5) A(7) / U(6) 36 / 139 Agatstn scre greater than 400 A(7) / A(7) Duke Treadmill Scre 38 / 149 Intermediate-risk Duke treadmill scre **** A(7) / A(7) 39 / 150 High-risk Duke treadmill scre **** A(8) / A(7) Risk Assessment: Preperative Evaluatin fr Nncardiac Surgery Withut Active Cardiac Cnditins Intermediate-Risk Surgery 43 / 157 Greater than r equal t 1 clinical risk factr Pr r unknwn functinal capacity (less than 4 METs) Vascular Surgery A(7) / U(6) 47 / 161 Greater than r equal t 1 clinical risk factr A(8) / A(7) Pr r unknwn functinal capacity (less than 4 METS) Risk Assessment: Within 3 Mnths f an Acute Crnary Syndrme STEMI 50 / 164 Hemdynamically stable, n recurrent chest A(8) / A(7) pain symptms r n signs f HF T evaluate fr inducible ischemia N prir crnary angigraphy UA/NSTEMI 52 / 166 Minr periperative risk predictr A(9) / A(8) Nrmal exercise tlerance (greater than r equal t 4 METS) Hemdynamically stable, n recurrent chest pain symptms r n signs f HF T evaluate fr inducible ischemia N prir crnary angigraphy Risk Assessment: Pstrevascularizatin (Percutaneus Crnary Interventin r Crnary Artery Bypass Graft) Symptmatic 4 Heart PET Scan 2018 v2 Prprietary

5 ACCF et al. Criteria # MPI / Stress Ech INDICATIONS (*Refer t Additinal Infrmatin sectin) cntraindicatins as nted in sectin Indicatins fr a Nuclear Cardiac Imaging / Mycardial Perfusin Study. Please see explanatin in Intrductin, paragraph 6 APPROPRIATE USE SCORE (4-9); A= Apprpriate; U=Uncertain (MPI / Stress Ech) 55 / 169 Evaluatin f ischemic equivalent A(8) / A(8) Asymptmatic 56 / 170 Incmplete revascularizatin Additinal revascularizatin feasible A(7) / A(7) 57 Less than 5 years after CABG U(5) 58 / 172 Greater than r equal t 5 years after CABG A(7) / U(6) 60 /174 Greater than r equal t 2 years after PCI U(6) / U(5) Assessment f Viability/Ischemia Ischemic Cardimypathy/Assessment f Viability 62 /176 Knwn severe LV dysfunctin Patient eligible fr revascularizatin A(9) / A(8) INDICATIONS FOR A NUCLEAR CARDIAC IMAGING/MYOCARDIAL PERFUSION STUDY: T qualify fr SPECT/MPI, the patient must meet ACCF/ASNC Apprpriateness criteria fr apprpriate indicatins abve and meets any ne f the fllwing cnditins: Stress echcardigraphy is nt indicated; OR Stress echcardigraphy has been perfrmed hwever findings were inadequate, there were technical difficulties with interpretatin, r results were discrdant with previus clinical data; OR MPI is preferential t stress echcardigraphy including but nt limited t fllwing cnditins: Ventricular paced rhythm Evidence f ventricular tachycardia Severe artic valve dysfunctin Severe Chrnic Obstructive Pulmnary Disease, (COPD) as defined as FEV1 30% predicted r FEV1 50% predicted plus respiratry failure r clinical signs f right heart failure. (GOLD classificatin f COPD access Cngestive Heart Failure (CHF) with current Ejectin Fractin (EF), 40% Inability t get an ech windw fr imaging Prir thractmy, (CABG, ther surgery) Obesity BMI>40 5 Heart PET Scan 2018 v2 Prprietary

6 Prly cntrlled hypertensin [generally abve 180 mm Hg systlic (bth physical stress and dbutamine stress may exacerbate hypertensin during stress ech)] Prly cntrlled atrial fibrillatin (Resting heart rate > 100 bpm n medicatin t cntrl rate) Inability t exercise requiring pharmaclgical stress test Segmental wall mtin abnrmalities at rest (e.g. due t cardimypathy, recent MI, r pulmnary hypertensin) OR 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 with Apprpriate Use Scres 4-9, as nted abve. ADDITIONAL INFORMATION: Cardiac neplasm and metastasis Aid in the determinatin f cardiac malignancy and may be helpful in detecting metastases f malignant cardiac tumrs. The applicatins fr Cardiac Viability Imaging with FDG PET are: The identificatin f patients with partial lss f heart muscle mvement r hibernating mycardium is imprtant in selecting candidates with cmprmised ventricular functin t determine apprpriateness fr revascularizatin. Distinguish between dysfunctinal but viable mycardial tissue and scar tissue in rder t affect management decisins in patients with ischemic cardimypathy and left ventricular dysfunctin. Use f class IC antiarrhythmic agents: Flecainide (Tambcr) and prpafenne (Rythml) are class IC anti arrhythmic agents. They are used t treat ventricular and supraventricular tachyarrhythmias. They are cntraindicated in patients with structural heart disease due t the risk f precipitating life-threatening ventricular arrhythmias. These drugs can depress systlic functin. They can suppress the sinus nde in patients with sick sinus syndrme and impair AV and infra ndal cnductin in patients with cnductin disease. Prpafenne has beta adrenergic receptr blcking effect. *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. 6 Heart PET Scan 2018 v2 Prprietary

7 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 prbabilities f CAD can be calculated frm the risk algrithms as fllws: Age (Years) < >60 Gender Typical / Definite Angina Pectris Atypical / Prbable 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 7 Heart PET Scan 2018 v2 Prprietary

8 REFERENCES ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM (2009) Apprpriate Use Criteria fr Cardiac Radinuclide Imaging. A Reprt f the American Cllege f Cardilgy Fundatin Apprpriate Use Criteria Task Frce, the American Sciety f Nuclear Cardilgy, the American Cllege f Radilgy, the American Heart Assciatin, the American Sciety f Echcardigraphy, the Sciety f Cardivascular Cmputed Tmgraphy, the Sciety fr Cardivascular Magnetic Resnance, and the Sciety f Nuclear Medicine Endrsed by the American Cllege f Emergency Physicians. J Am Cll Cardil, 53, di: /j.jacc 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. di: /j.jacc (Published nline Nvember 19, 2010) ACC/AHA/AATS/PCNA/SCAI/STS 2014 Fcused Update f the Guideline fr the Diagnsis and Management f Patients With Stable Ischemic Heart Disease A 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 Disease A 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 Beanlands, R.S., Hendry, P.J., Masters, R.G., dekemp, R.A., Wdend, K., & Ruddy, T.D. (1998). Delay in revascularizatin is assciated with increased mrtality rate in patients with severe left ventricular dysfunctin and viable mycardium n flurine 18-FDG PET imaging. Circulatin, 98(II), PMID: Beanlands, R.S., Nichl, G., Husztim, E., Humen, D., Racine, N., Freeman, M.,... PARR-2 Investigatr. (2007). F-18-flurdexyglucse PET imaging-assisted management f 8 Heart PET Scan 2018 v2 Prprietary

9 patients with severe left ventricular dysfunctin and suspected crnary disease: A randmized, cntrlled trial (PARR-2). Jurnal f the American Cllege f Cardilgy, 50, Retrieved frm Beanlands, R.S., Ruddy, T.D., dekemp R.A., Iwanchk, R.M., Cates, G., Freeman, M.,... PARR-2 Investigatr. (2002). PET and recvery fllwing revascularizatin (PARR-1): The imprtance f scar and the develpment f a predictin rule fr the degree f recvery f left ventricular functin. Jurnal f the American Cllege f Cardilgy, 40, Retrieved frmhttp:// Bengel, F.M., Higuchi, T., Javadi, M.S., & Lautamaki, R. (2009). Cardiac PET. Jurnal f the American Cllege f Cardilgy, 54, Retrieved frm Blankstein R., Osbrn M., Naya M., Waller A., Kim CK., Murthy VL., DiCarli MF. (2014) Cardiac Psitrn Emissin Tmgraphy Enhances Prgnstic Assessments f Patients With Suspected Cardiac Sarcidsis. Jurnal f the American Cllege f Cardilgy Centers fr Medicare and Medicaid Services. Medicare Natinal Cverage Determinatins Manual. Retrieved frm Di Carli, M.F., & Hachamvitch, R. (2007). New technlgy fr nninvasive evaluatin f crnary artery disease. Circulatin, 115, di: / CIRCULATIONAHA Lertsburapa, K., Ahlberg, A.W., Batemanm T.M., Katten, D., Vlker, L., Cullm, S.J., & Heller, G.V. (2008). Independent and incremental prgnstic value f left ventricular ejectin fractin determined by stress gated rubidium-82 PET imaging in patients with knwn r suspected crnary artery disease. Jurnal f Nuclear Cardilgy, 15, di: /BF Niazi, O.T., Alhaj, E., Rahman, I. U., Waller, A, Ghesani,& N., Klaphlz, M. (2015, March). Detectin f Cardiac Metastasis by F-18 Flur-2-Dexyglucse Psitrn Emissin Tmgraphy. J Am Cll Cardil. 65(10_S). di: /s (15) Prakash, R., dekemp, R.A., Ruddy, T.D., Kitsikis, A., Hart, R., Beauchesne, L.,... Beanlands, R.S. (2004). Ptential utility f rubidium-82 PET quantificatin in patients with 3-vessel crnary artery disease. J urnal f Nuclear Cardilgy, 11, Retrieved frm Rahbar, K., Seifarth, H., Schäfers, M., Stegger, L., Hffmeier, A., Spieker, T.,..., Weckesser, M. (2012, June). Differentiatin f malignant and benign cardiac tumrs using 18F-FDG PET/CT. J Nucl Med. 53(6), di: /jnumed Epub 2012 May Heart PET Scan 2018 v2 Prprietary

10 Schindler, T.H., Schelbert, H.R., Quercili, A., & Dilsizian, V. (2010). Cardiac PET imaging fr the detectin and mnitring f crnary artery disease and micrvascular health. Jurnal f the American Cllege f Cardilgy Imaging, 3(6), di: /j.jcmg Sciety f Nuclear Medicine PET/CT Utilizatin Task Frce. PET Prfessinal Resurces and Outreach Service Cardiac PET and PET/CT Imaging Practice Guidelines. Retrieved frm Tarakji, K.G., Brunken, R., McCarthy, P.M., Al-Chekakie, M.O., Abdel-Latif, A., Pthier, C.E.,... Lauer, M.S. (2006). Mycardial viability testing and the effect f early interventin in patients with advanced left ventricular systlic dysfunctin. Circulatin, 113, di: /CIRCULATIONAHA Yshinaga, K., Chw, B.J., Williams, K., Chen, L., dekemp, R.A., Garrard, L.,... Beanlands, R.S.B. (2006). What is the prgnstic value f mycardial perfusin imaging using rubidium-82 PET? Jurnal f the American Cllege f Cardilgy, 48, Retrieved frm 10 Heart PET Scan 2018 v2 Prprietary

Original Date: July 1999 HEART (Cardiac) PET

Natinal Imaging Assciates, Inc. Clinical guidelines Original Date: July 1999 HEART (Cardiac) PET Page 1 f 10 CPT Cdes: 78459, 78491, 78492 Last Reviewed Date: September 2015 Guideline Number: NIA_CG_072