CLINICAL MEDICAL POLICY

Policy Name: Policy Number: Responsible Department(s): CLINICAL MEDICAL POLICY Cardiovascular Nuclear Medicine (L33960) MP-055-MC-KY Medical Management Provider Notice Date: 05/01/2018 Issue Date: 06/01/2018 Effective Date: 06/01/2018 Annual Approval Date: 03/21/2019 Revision Date: Products: Application: N/A Page Number(s): 1 of 17 Kentucky Medicare Assured All participating and nonparticipating hospitals and providers DISCLAIMER Gateway Health (Gateway) medical policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT Gateway Health may provide coverage under the medical-surgical benefits of the Company s Medicare products for medically necessary CV Nuclear Medicine. This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records. Policy No. MP-055-MC-KY Page 1 of 17

PROCEDURES CMS NATIONAL COVERAGE POLICY Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act. Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: Title XVIII of the Social Security Act (SSA): Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Code of Federal Regulations: 42 CFR Section 410.32 indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter). CMS Publications: CMS Publication 100-04, Medicare Claims Processing, Chapter 12: 70: Payment conditions for radiology services CMS Publication 100-04, Medicare Claims Processing, Chapter 13: 20: Payment conditions for radiology services 50: Payment for the supply of a radiopharmaceutical diagnostic imaging agent and/or pharmacologic stressing agent with diagnostic nuclear medicine procedures. 90: Services of portable X-Ray suppliers 1. Coverage Indications, Limitations, and/or Medical Necessity A. Abstract: Cardiovascular nuclear imaging employs non-invasive techniques to assess alterations in coronary artery flow, and ventricular function. The specific imaging technique (perfusion versus ventricular function) and the reason for the imaging determine which radionuclide agent is employed. A myocardial perfusion study utilizes an imaging isotope agent that reflects segmental and global myocardial blood flow and uptake, the interpretation of which is used to make inference about the presence of scar and ischemia. Policy No. MP-055-MC-KY Page 2 of 17

Ventricular function studies utilize specific imaging isotopes to outline the borders of the ventricular endocardium, or to identify the ventricular blood pool independent of the surrounding myocardium. The motion of the left ventricle, synchronized with the electrocardiogram, is used to generate wall motion and ejection fraction information. These tests may be performed at rest and during exercise, or with pharmacologic intervention when exercise cannot be performed. The acquisition of the images may be planar (single plane) or by multiple planes with computer integration, SPECT (single-photon emission computer tomography). B. Indications: 1) Cardiovascular nuclear imaging is indicated for the following: Assessment of the functional and prognostic importance of angina; Diagnostic evaluation of patients with chest pain and uninterpretable or equivocal ECG changes caused by drugs, bundle branch block, or left ventricular hypertrophy; Assessment of congenital anomalies of coronary arteries; Risk assessment or re-evaluation of disease in patients who are asymptomatic or have stable symptoms, with known atherosclerotic heart disease on catheterization or SPECT perfusion imaging, who have not had a revascularization procedure within the past two years; Detection of coronary artery disease in patients, without chest pain syndrome, with newonset of diagnosed heart failure or left ventricular systolic dysfunction; Evaluation of ischemic versus non-ischemic cardiomyopathy when cardiac catheterization / coronary angiography are not planned; Evaluation of myocardial perfusion and/or function before and after coronary artery bypass surgery or other re-perfusion procedures; Quantification and surveillance of myocardial infarction and prognostication in patients with infarction; Assessment of congenital anomalies of coronary arteries; Preoperative assessment for non-cardiac surgery, when used to determine risk for surgery and/or perioperative management in: patients with minor or intermediate clinical risk predictors and poor functional capacity; Patients with intermediate or high likelihood of coronary heart disease, or patients with poor functional capacity undergoing high risk non-cardiac surgery; The "ACA/AHA 2007 Guidelines on Perioperative Cardiovascular Evaluation and Care for Non-Cardiac Surgery" (JACC 2007; 50:e159-e242) provides this information: Policy No. MP-055-MC-KY Page 3 of 17

High risk surgery: aortic and peripheral vascular surgery Intermediate risk surgery: intraperitoneal and intrathoracic surgery, carotid endarterectomy, head & neck surgery, orthopedic surgery, prostate surgery. Low risk surgery: endoscopic procedures, superficial surgery, cataract surgery, breast surgery, ambulatory surgery Poor functional capacity = less than 4 METS Clinical risk factors: a) history of ischemic heart disease b) history of compensated or prior heart failure c) history of cerebrovascular disease d) diabetes mellitus e) renal insufficiency Decision-making for testing is based upon the presence of multiple clinical risk factors, the level of functional capacity, the risk of the surgery and the likelihood that the results of the cardiac testing would change the management. Evaluation of ventricular function in patients with non-ischemic myocardial disease; Evaluation of patients in whom an accurate measure of the ejection fraction is needed to make a determination of whether to implant a defibrillator or biventricular pacemaker; Evaluation of a patient receiving chemotherapeutic drugs which are potentially cardiotoxic (e.g., adriamycin). First pass studies will be considered medically necessary only when information sought is immediately relevant to the management of the patient s clinical condition, and has not been previously obtained or likely to be obtained from other planned tests such as echocardiography or equilibrium gated blood pool studies. First pass studies may be indicated for the assessment and identification of shunts. Infarct avid scintigraphy is indicated in patients in whom it is not possible to make a definitive diagnosis of myocardial infarction by EKG or enzyme testing. Patient selection should be based on clinical grounds: Patients with a high pretest probability of disease are not usually candidates for a study for diagnostic purposes, though the size and reversibility of a defect and its functional consequences may be required for clinical decision-making. Patients with a moderate probability of disease benefit the most from the study when the diagnosis is in question. Selection of tests should be made within the context of other tests, scheduled and previously performed, so that the anticipated information obtained is unique and not redundant. Policy No. MP-055-MC-KY Page 4 of 17

C. Limitations: 1) Special Equipment Requirements: Given the limitations of uptake, low photon energy and redistribution, the cardiac blood pool codes and perfusion imaging codes are not generally covered on the same date of service. However, in light of the predictive value of exercise-induced changes in ejection fraction, an exception will be made to allow first pass, single study with exercise along with the appropriate perfusion studies. Providers who bill this service must certify within their records that their laboratories are specially equipped to process such studies. The rapid uptake, relatively low photon energy and redistribution of thallium 201 preclude its application to studies for gated images (78478 and 78480, for dates of service prior to 01/01/2010) in most laboratories. Therefore, CPT procedure codes 78478 and 78480 (for dates of service prior to 01/01/2010) are generally not payable with HCPCS code A9505 (thallous chloride). However, an exception will be made to allow this combination for laboratories that have at least double-headed cameras and the appropriate software to facilitate the count. Such providers must certify that their laboratories are specially equipped to process such studies. Cardiac blood pool imaging studies are described by the codes 78472, 78473, 78481, 78483, 78494 (with add-on code 78496). Only one code from the series (with appropriate add-on) may be reported on a single date of service. All cardiovascular nuclear tests and stress tests must be referred by a physician or a qualified non-physician provider. All stress tests must be performed under the direct supervision of a physician. The nuclear test components must be performed under the general supervision of a physician. Myocardial perfusion studies performed based on the presence of risk factors in the absence of cardiac symptoms, cardiac abnormalities on physical examination, or abnormalities on cardiac testing (e.g., electrocardiographic tests, echocardiography, etc) will be considered screening and denied as not covered by Medicare. Tests that are anticipated to provide information duplicative of another test already performed will be denied as not medically necessary. Tests performed when the results would not be anticipated to influence medical management decisions will be denied as not medically necessary. Myocardial perfusion studies performed subsequent to a diagnostic myocardial PET scan will denied as not medically necessary. Infarct avid scintigraphy will be denied if the diagnosis of myocardial infarction has already been confirmed by enzymes and/or EKG. Policy No. MP-055-MC-KY Page 5 of 17

Tests performed unrelated to changes in a patient's signs or symptoms, or for immediate pre-operative evaluation will be denied as medically unnecessary. Tests performed for risk assessment prior to high risk non-cardiac surgery in asymptomatic patients within one year following normal catheterization or non-invasive test will be considered medically unnecessary and denied. Tests performed for preoperative evaluation in patients undergoing low-risk surgery will be denied. D. Other Comments: For claims submitted to the Part A MAC: this coverage determination also applies within states outside the primary geographic jurisdiction with facilities that have nominated CGS to process their claims. Bill type codes only apply to providers who bill these services to the Part A MAC. Bill type codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons. The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare. The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes. E. Summary of Evidence N/A F. Analysis of Evidence (Rationale for Determination) N/A 2. Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Gateway Health at any time pursuant to the terms of your provider agreement. COVERAGE DETERMINATIONS Gateway Health follows the coverage determinations made by CMS as outlined in either the national coverage determinations (NCD) or the state-specific local carrier determination (LCD). There is no NCD that is specific to the CV Nuclear Medicine policy. This policy supplements the existing and related NCDs but does not repeat the existing NCDs. Please follow the CGS Administrators, LLC LCD L33960 for CV Nuclear Medicine: Policy No. MP-055-MC-KY Page 6 of 17

Related NCDs: Electrocardiographic Services (20.15): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=179&ncdver=2&docid=20.15&from2=search.asp&bc=gaaaaagaaaaaaa%3d%3d& Cardiac Pacemaker Evaluation Services (20.8.1): https://www.cms.gov/medicare-coverage-database/details/ncddetails.aspx?ncdid=160&ncdver=1&bc=aaaagaaaaaaaaa%3d%3d& CODING REQUIREMENTS Bill Type Codes: Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims. 011x Hospital Inpatient (Including Medicare Part A) 012x Hospital Inpatient (Medicare Part B only) 013x Hospital Outpatient 021x Skilled Nursing - Inpatient (Including Medicare Part A) 085x Critical Access Hospital Revenue Codes: Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the policy, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes. Revenue codes only apply to providers who bill these services to the Part A MAC. Revenue codes do not apply to physicians, other professionals and suppliers who bill these services to the carrier or Part B MAC. Please note that not all revenue codes apply to every type of bill code. Providers are encouraged to refer to the FISS revenue code file for allowable bill types. Similarly, not all revenue codes apply to each CPT/HCPCS code. Providers are encouraged to refer to the FISS HCPCS file for allowable revenue codes. 0340 Nuclear Medicine - General Classification 0341 Nuclear Medicine - Diagnostic 0482 Cardiology - Stress Test 0636 Pharmacy - Drugs Requiring Detailed Coding 0960 Professional Fees - General Classification 0969 Professional Fees - Other Professional Fee 0974 Professional Fees - Radiology - Nuclear 0982 Professional Fees - Outpatient Services Policy No. MP-055-MC-KY Page 7 of 17

CPT/HCPCS Codes Group 1 Paragraph: For dates of service on/after 1/1/2009, J2785 should be used to report regadenoson for Part A and Part B. Group 1 Codes: Covered Procedure Codes CPT/HCPCS Description Codes 78451 MYOCARDIAL PERFUSION IMAGING, TOMOGRAPHIC (SPECT) (INCLUDING ATTENUATION CORRECTION, QUALITATIVE OR QUANTITATIVE WALL MOTION, EJECTION FRACTION BY FIRST PASS OR GATED TECHNIQUE, ADDITIONAL QUANTIFICATION, WHEN PERFORMED); SINGLE STUDY, AT REST OR STRESS (EXERCISE OR PHARMACOLOGIC) 78452 MYOCARDIAL PERFUSION IMAGING, TOMOGRAPHIC (SPECT) (INCLUDING ATTENUATION CORRECTION, QUALITATIVE OR QUANTITATIVE WALL MOTION, EJECTION FRACTION BY FIRST PASS OR GATED TECHNIQUE, ADDITIONAL QUANTIFICATION, WHEN PERFORMED); MULTIPLE STUDIES, AT REST AND/OR STRESS (EXERCISE OR PHARMACOLOGIC) AND/OR REDISTRIBUTION AND/OR REST REINJECTION 78453 MYOCARDIAL PERFUSION IMAGING, PLANAR (INCLUDING QUALITATIVE OR QUANTITATIVE WALL MOTION, EJECTION FRACTION BY FIRST PASS OR GATED TECHNIQUE, ADDITIONAL QUANTIFICATION, WHEN PERFORMED); SINGLE STUDY, AT REST OR STRESS (EXERCISE OR PHARMACOLOGIC) 78454 MYOCARDIAL PERFUSION IMAGING, PLANAR (INCLUDING QUALITATIVE OR QUANTITATIVE WALL MOTION, EJECTION FRACTION BY FIRST PASS OR GATED TECHNIQUE, ADDITIONAL QUANTIFICATION, WHEN PERFORMED); MULTIPLE STUDIES, AT REST AND/OR STRESS (EXERCISE OR PHARMACOLOGIC) AND/OR REDISTRIBUTION AND/OR REST REINJECTION 78466 MYOCARDIAL IMAGING, INFARCT AVID, PLANAR; QUALITATIVE OR QUANTITATIVE 78468 MYOCARDIAL IMAGING, INFARCT AVID, PLANAR; WITH EJECTION FRACTION BY FIRST PASS TECHNIQUE 78469 MYOCARDIAL IMAGING, INFARCT AVID, PLANAR; TOMOGRAPHIC SPECT WITH OR WITHOUT QUANTIFICATION 78472 CARDIAC BLOOD POOL IMAGING, GATED EQUILIBRIUM; PLANAR, SINGLE STUDY AT REST OR STRESS (EXERCISE AND/OR PHARMACOLOGIC), WALL MOTION STUDY PLUS EJECTION FRACTION, WITH OR WITHOUT ADDITIONAL QUANTITATIVE PROCESSING 78473 CARDIAC BLOOD POOL IMAGING, GATED EQUILIBRIUM; MULTIPLE STUDIES, WALL MOTION STUDY PLUS EJECTION FRACTION, AT REST AND STRESS (EXERCISE AND/OR PHARMACOLOGIC), WITH OR WITHOUT ADDITIONAL QUANTIFICATION 78481 CARDIAC BLOOD POOL IMAGING (PLANAR), FIRST PASS TECHNIQUE; SINGLE STUDY, AT REST OR WITH STRESS (EXERCISE AND/OR PHARMACOLOGIC), WALL MOTION STUDY PLUS EJECTION FRACTION, WITH OR WITHOUT QUANTIFICATION 78483 CARDIAC BLOOD POOL IMAGING (PLANAR), FIRST PASS TECHNIQUE; MULTIPLE STUDIES, AT REST AND WITH STRESS (EXERCISE AND/OR PHARMACOLOGIC), WALL MOTION STUDY PLUS EJECTION FRACTION, WITH OR WITHOUT QUANTIFICATION 78494 CARDIAC BLOOD POOL IMAGING, GATED EQUILIBRIUM, SPECT, AT REST, WALL MOTION STUDY PLUS EJECTION FRACTION, WITH OR WITHOUT QUANTITATIVE PROCESSING Policy No. MP-055-MC-KY Page 8 of 17

78496 CARDIAC BLOOD POOL IMAGING, GATED EQUILIBRIUM, SINGLE STUDY, AT REST, WITH RIGHT VENTRICULAR EJECTION FRACTION BY FIRST PASS TECHNIQUE (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) 93015 CARDIOVASCULAR STRESS TEST USING MAXIMAL OR SUBMAXIMAL TREADMILL OR BICYCLE EXERCISE, CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING, AND/OR PHARMACOLOGICAL STRESS; WITH SUPERVISION, INTERPRETATION AND REPORT 93016 CARDIOVASCULAR STRESS TEST USING MAXIMAL OR SUBMAXIMAL TREADMILL OR BICYCLE EXERCISE, CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING, AND/OR PHARMACOLOGICAL STRESS; SUPERVISION ONLY, WITHOUT INTERPRETATION AND REPORT 93017 CARDIOVASCULAR STRESS TEST USING MAXIMAL OR SUBMAXIMAL TREADMILL OR BICYCLE EXERCISE, CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING, AND/OR PHARMACOLOGICAL STRESS; TRACING ONLY, WITHOUT INTERPRETATION AND REPORT 93018 CARDIOVASCULAR STRESS TEST USING MAXIMAL OR SUBMAXIMAL TREADMILL OR BICYCLE EXERCISE, CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING, AND/OR PHARMACOLOGICAL STRESS; INTERPRETATION AND REPORT ONLY A9500 TECHNETIUM TC-99M SESTAMIBI, DIAGNOSTIC, PER STUDY DOSE A9501 TECHNETIUM TC-99M TEBOROXIME, DIAGNOSTIC, PER STUDY DOSE A9502 TECHNETIUM TC-99M TETROFOSMIN, DIAGNOSTIC, PER STUDY DOSE A9505 THALLIUM TL-201 THALLOUS CHLORIDE, DIAGNOSTIC, PER MILLICURIE A9512 TECHNETIUM TC-99M PERTECHNETATE, DIAGNOSTIC, PER MILLICURIE A9538 TECHNETIUM TC-99M PYROPHOSPHATE, DIAGNOSTIC, PER STUDY DOSE, UP TO 25 MILLICURIES A9560 TECHNETIUM TC-99M LABELED RED BLOOD CELLS, DIAGNOSTIC, PER STUDY DOSE, UP TO 30 MILLICURIES J0153 INJECTION, ADENOSINE, 1 MG (NOT TO BE USED TO REPORT ANY ADENOSINE PHOSPHATE COMPOUNDS) J1245 INJECTION, DIPYRIDAMOLE, PER 10 MG J1250 INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG J2785 INJECTION, REGADENOSON, 0.1 MG J3490 UNCLASSIFIED DRUGS ICD-10 Codes that Support Medical Necessity Group 1 Paragraph: It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. The correct use of an ICD-10-CM code does not assure coverage of a service. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. ICD-10-CM Codes That Support Medical Necessity for Perfusion with or without Functional Studies: CPT codes 78460, 78461, 78464, 78465, 78478, 78480, (effective for dates of service prior to 01/01/2010) CPT codes 78451, 78452, 78453, 78454 (effective for dates of service on or after 01/01/2010) CPT codes 78472, 78473, 78481, 78483, 93015, 93016, 93017, and 93018 Covered Diagnosis Codes ICD-10 Description Codes I20.0 Unstable angina I20.1 Angina pectoris with documented spasm Policy No. MP-055-MC-KY Page 9 of 17

I20.8 Other forms of angina pectoris I20.9 Angina pectoris, unspecified I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery I21.29 ST elevation (STEMI) myocardial infarction involving other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I21.4 Non-ST elevation (NSTEMI) myocardial infarction I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.8 Subsequent non-st elevation (NSTEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I23.7 Postinfarction angina I23.8 Other current complications following acute myocardial infarction I24.0 Acute coronary thrombosis not resulting in myocardial infarction I24.1 Dressler's syndrome I24.8 Other forms of acute ischemic heart disease I24.9 Acute ischemic heart disease, unspecified I25.10 Atherosclerotic heart disease of native coronary artery without angina pectoris I25.110 Atherosclerotic heart disease of native coronary artery with unstable angina pectoris I25.111 Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm I25.118 Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris I25.119 Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris I25.2 Old myocardial infarction I25.3 Aneurysm of heart I25.41 Coronary artery aneurysm I25.42 Coronary artery dissection I25.5 Ischemic cardiomyopathy I25.6 Silent myocardial ischemia I25.700 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris I25.701 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm I25.708 Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris Policy No. MP-055-MC-KY Page 10 of 17

I25.709 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris I25.710 Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina pectoris I25.711 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with documented spasm I25.718 Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina pectoris with other forms of angina pectoris I25.719 Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris I25.720 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable angina pectoris I25.721 Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina pectoris with documented spasm I25.728 Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina pectoris I25.729 Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina pectoris I25.730 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina pectoris I25.731 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina pectoris with documented spasm I25.738 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina pectoris I25.739 Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina pectoris I25.750 Atherosclerosis of native coronary artery of transplanted heart with unstable angina I25.751 Atherosclerosis of native coronary artery of transplanted heart with angina pectoris with documented spasm I25.758 Atherosclerosis of native coronary artery of transplanted heart with other forms of angina pectoris I25.759 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm I25.760 Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina I25.761 Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina pectoris with documented spasm Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms I25.768 of angina pectoris Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified I25.769 angina pectoris I25.790 Atherosclerosis of other coronary artery bypass graft(s) with unstable angina pectoris Atherosclerosis of other coronary artery bypass graft(s) with angina pectoris with I25.791 documented spasm Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina I25.798 pectoris Policy No. MP-055-MC-KY Page 11 of 17

I25.799 Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina pectoris I25.811 Atherosclerosis of native coronary artery of transplanted heart without angina pectoris I25.812 Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina pectoris I25.82 Chronic total occlusion of coronary artery I25.83 Coronary atherosclerosis due to lipid rich plaque I25.84 Coronary atherosclerosis due to calcified coronary lesion I25.89 Other forms of chronic ischemic heart disease I25.9 Chronic ischemic heart disease, unspecified I46.2 Cardiac arrest due to underlying cardiac condition I46.8 Cardiac arrest due to other underlying condition I49.01 Ventricular fibrillation I49.02 Ventricular flutter I50.1 Left ventricular failure, unspecified I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.31 Acute diastolic (congestive) heart failure I50.32 Chronic diastolic (congestive) heart failure I50.33 Acute on chronic diastolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure I51.81 Takotsubo syndrome I51.89 Other ill-defined heart diseases Q24.5 Malformation of coronary vessels R06.00 Dyspnea, unspecified R06.01 Orthopnea R06.02 Shortness of breath R06.09 Other forms of dyspnea R06.1 Stridor R06.2 Wheezing R06.4 Hyperventilation R07.2 Precordial pain R07.82 Intercostal pain R07.89 Other chest pain R07.9 Chest pain, unspecified R94.31 Abnormal electrocardiogram [ECG] [EKG] T82.817A Embolism due to cardiac prosthetic devices, implants and grafts, initial encounter T82.827A Fibrosis due to cardiac prosthetic devices, implants and grafts, initial encounter T82.837A Hemorrhage due to cardiac prosthetic devices, implants and grafts, initial encounter T82.847A Pain due to cardiac prosthetic devices, implants and grafts, initial encounter T82.857A Stenosis of other cardiac prosthetic devices, implants and grafts, initial encounter T82.867A Thrombosis due to cardiac prosthetic devices, implants and grafts, initial encounter Policy No. MP-055-MC-KY Page 12 of 17

T86.21 Heart transplant rejection T86.22 Heart transplant Failure T86.23 Heart transplant infection T86.290 Cardiac allograft vasculopathy T86.31 Heart-lung transplant rejection T86.32 Heart-lung transplant failure T86.33 Heart-lung transplant infection Z01.810* Encounter for preprocedural cardiovascular examination Z94.1 Heart transplant status Z95.1 Presence of aortocoronary bypass graft Z95.5 Presence of coronary angioplasty implant and graft Z98.61 Coronary angioplasty status Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: * Use ICD-10 code Z01.810 for those tests which were performed to evaluate pre-operative risk (see Indications section above) but for whom the test was negative. (A positive test should be coded with the results of the test.) Group 2 Paragraph: ICD-10-CM Codes That Support Medical Necessity for Cardiac Blood Pool Studies, CPT codes 78472, 78473, 78481, 78483, 78494 and 78496 Group 2 Codes: Covered Diagnosis Codes ICD-10 Description Codes I50.21 Acute systolic (congestive) heart failure I50.22 Chronic systolic (congestive) heart failure I50.23 Acute on chronic systolic (congestive) heart failure I50.41 Acute combined systolic (congestive) and diastolic (congestive) heart failure I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure I50.43 Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure Z01.30 Encounter for examination of blood pressure without abnormal findings Z01.31 Encounter for examination of blood pressure with abnormal findings Z01.818* Encounter for other preprocedural examination Z01.82 Encounter for allergy testing Z08* Encounter for follow-up examination after completed treatment for malignant neoplasm Z09* Encounter for follow-up examination after completed treatment for conditions other than malignant neoplasm Z51.11 Encounter for antineoplastic chemotherapy Z51.12 Encounter for antineoplastic immunotherapy Z51.81* Encounter for therapeutic drug level monitoring Group 2 Medical Necessity ICD-10 Codes Asterisk Explanation: *Report Z01.818 when the test is performed as a baseline study before chemotherapy *Report Z51.81 for subsequent monitoring while the patient is receiving chemotherapy. *Report Z08 or Z09 for testing when chemotherapy is completed. Policy No. MP-055-MC-KY Page 13 of 17

ICD-10 codes I50.21-I50.23 and I50.41-I50.43 will be considered to support medical necessity only when performed to calculate ejection fraction in those patients being actively considered for defibrillator or biventricular pacemaker placement, where ejection fraction is a determining factor in the decision. Group 3 Paragraph: ICD-10-CM Codes That Support Medical Necessity for Infarct avidity studies only, CPT 78466, 78468 and 78469: Group 3 Codes: Diagnosis Codes ICD-10 Codes Description I21.01 ST elevation (STEMI) myocardial infarction involving left main coronary artery I21.02 ST elevation (STEMI) myocardial infarction involving left anterior descending coronary artery I21.09 ST elevation (STEMI) myocardial infarction involving other coronary artery of anterior wall I21.11 ST elevation (STEMI) myocardial infarction involving right coronary artery I21.19 ST elevation (STEMI) myocardial infarction involving other coronary artery of inferior wall I21.21 ST elevation (STEMI) myocardial infarction involving left circumflex coronary artery I21.29 ST elevation (STEMI) myocardial infarction involving other sites I21.3 ST elevation (STEMI) myocardial infarction of unspecified site I21.4 Non-ST elevation (NSTEMI) myocardial infarction I22.0 Subsequent ST elevation (STEMI) myocardial infarction of anterior wall I22.1 Subsequent ST elevation (STEMI) myocardial infarction of inferior wall I22.2 Subsequent non-st elevation (NSTEMI) myocardial infarction I22.8 Subsequent ST elevation (STEMI) myocardial infarction of other sites I22.9 Subsequent ST elevation (STEMI) myocardial infarction of unspecified site I25.82 Chronic total occlusion of coronary artery R07.2 Precordial pain R07.82 Intercostal pain R07.9 Chest pain, unspecified R94.31 Abnormal electrocardiogram [ECG] [EKG] ICD-10 Codes that DO NOT Support Medical Necessity Additional ICD-10 Information N/A REIMBURSEMENT Participating facilities will be reimbursed per their Gateway Health contract. Policy No. MP-055-MC-KY Page 14 of 17

GENERAL INFORMATION Associated Information N/A Sources of Information This bibliography presents those sources that were obtained during the development of this policy. CGS is not responsible for the continuing viability of Web site addresses listed below. American College of Cardiology - Self Assessment Program Syllabus. Botnovich E, Dae M, O'Connell W, Ortendahl D, Hatner R. The scinitigraphic evaluation of the cardiovascular system. Cardiology Parmley (Ed).1994. Brindis RG, Douglas PS, Hendel RC, et al. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): A Report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology. J. Am Coll Cardiology (2005);46:1587-1605. Committee on Exercise Testing, ACC/AHA Guidelines for Exercise Testing. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. July 1997;30(1):260-311. Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 Guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): Developed in Collaboration With the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. J Am Coll Cardiol (2007);50:1707-1732. Johnson LL, Rodney RA, Vaccarino RA, et al. Left ventricular perfusion and performance from a single radiopharmaceutical and one camera. J Nucl Med 1992;33:1411-1416. Klocke FJ, Baird MG, Bateman TM, et al. ACC/AHA/ASNC Guidelines for the clinical use of cardiac radionuclide imaging: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to revise the 1995 guidelines for the clinical use of radionuclide imaging). 2003: downloaded from http://www.acc.org/clinical/guidelines/radio/rni_fulltext.pdf Lee T, Cardiac Noninvasive Testing. In: Braunwald E, Goldman L. editors, Primary Cardiology. 2nd edition. Elsevier Science 2003:47-61. McFalls EO, Ward HB, Moritz TE, et al. Coronary-artery revascularization before elective major vascular surgery. NEJM 2004;351:2795-2804 Policy No. MP-055-MC-KY Page 15 of 17

Palmas W, Friedman JD, Diamond GA, Silber H, Kiat H, Berman D. Incremental value of simultaneous assessment of myocardial function and perfusion with technetium-99m sestamibi for prediction of extent of coronary artery disease. JACC. 1995;25(5):1024-1031. Shaw LJ, Heinle SK, Borges-Neto S, Kesler K, Coleman RE, Jones RH for the Duke Noninvasive Research Working Group. Prognosis by measurements of left ventricular function during exercise. J Nucl Med 1998;39:140-146. St John Sutton, MG, Rutherford JD, editors. Clinical Cardiovascular Imaging: A Companion to Braunwald's Heart Disease. Elsevier Saunders. 2004. Wachers FJ, Soufer R, Zaret BL. Nuclear Cardiology. In: Heart Disease: A textbook of Cardiovascular Medicine. 6th edition. Braunwald E, Zipes D and Libby P, editors. 2001:273-304 Ward RP, Mouaz HA, Grossman GB, et al. American Society of Nuclear Cardiology review of the ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI). J Nucl Cardiol 2007;14:e26-38. Zaret BL, Beller GA. Nuclear Cardiology, State of the Art and Future Directions. Mosby 1999. The following source was used in reviewing a reconsideration request in November, 2008: Mariano-Goulart D, Dechaux L, Rouzet F, et al. Diagnosis of diffuse and localized arrhythmogenic right ventricular dysplasia by gated blood-pool SPECT. The Journal of Nuclear Medicine. Sept 2007;48(9):1416-1423. In review of a reconsideration request for July 2009, the New York Cardiology CAC representative was consulted. Bibliography N/A POLICY SOURCE(S) Reference Sources Centers for Medicare and Medicaid Services (CMS), Local Coverage Determination (LCD). No. L33960: Cardiovascular Nuclear Medicine. Effective 10/01/2015. Accessed on March 6, 2018 and available at: S:\Medical Policy Development\MEDICARE POLICIES\OH Medicare Medical Policies\2018 OH Medicare Medical Policies\MP-055-MC-OH CV Nuclear Medicine\Research and Information\CGS LCD CV Nuclear Medicine (L33960)_aspx.mht Policy No. MP-055-MC-KY Page 16 of 17

Policy History Date Activity 03/06/2018 Initial policy developed 03/21/2018 QI/UM Committee approval 06/01/2018 Provider effective date Policy No. MP-055-MC-KY Page 17 of 17