Medical Policy Cardiac Applications of PET Scanning

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1 Medical Policy Cardiac Applications of PET Scanning Table of Contents Policy: Commercial Coding Information Information Pertaining to All Policies Policy: Medicare Description References Authorization Information Policy History Policy Number: 623 BCBSA Reference Number: Related Policies Miscellaneous Applications of Positron Emission Tomography (PET), #624 Oncologic Applications of PET Scanning, #229 PET Scanning in Oncology to Detect Early Response during Treatment, #335 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity Cardiac PET scanning may be MEDICALLY NECESSARY to assess myocardial perfusion and thus diagnose coronary artery disease in patients with indeterminate SPECT scan; or in patients for whom SPECT could be reasonably expected to be suboptimal in quality on the basis of body habitus. Cardiac PET scanning may be MEDICALLY NECESSARY to assess the myocardial viability in patients with severe left ventricular dysfunction as a technique to determine candidacy for a revascularization procedure. (See Policy Guidelines regarding the relative effectiveness of PET and SPECT scanning.) Cardiac PET scanning may be MEDICALLY NECESSARY for the diagnosis of cardiac sarcoidosis in patients who are unable to undergo magnetic resonance imaging (MRI) scanning. Examples of patients who are unable to undergo MRI include, but are not limited to, patients with pacemakers, automatic implanted cardioverter-defibrillators (AICDs), or other metal implants. Cardiac PET scans as a screening test in the absence of signs or symptoms of a disease or condition is INVESTIGATIONAL. Medicare HMO Blue SM and Medicare PPO Blue SM Members PET for Perfusion of the Heart BCBSMA covers PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical Rubidium 82 (Rb 82) provided the following requirements are met for Medicare HMO Blue and Medicare PPO Blue members in accordance with CMS NCD: 1

2 The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test(s) whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.) For any PET scan for which Medicare payment is claimed for dates of services prior to July 1, 2001, the claimant must submit additional specified information on the claim form (including proper codes and/or modifiers), to indicate the results of the PET scan. The claimant must also include information on whether the PET scan was performed after an inconclusive noninvasive cardiac test. The information submitted with respect to the previous noninvasive cardiac test must specify the type of test performed prior to the PET scan and whether it was inconclusive or unsatisfactory. These explanations are in the form of special G codes used for billing PET scans using Rb 82. Beginning July 1, 2001, claims should be submitted with the appropriate codes. BCBSMA covers PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical ammonia N-13 provided the following requirements are met for Medicare HMO Blue and Medicare PPO Blue members in accordance with CMS NCD: The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.) National Coverage Determination (NCD) for PET for Perfusion of the Heart ( ) PET for Myocardial Viability FDG PET is covered for the determination of myocardial viability following an inconclusive single photon emission computed tomography (SPECT) test from July 1, 2001, through September 30, Only full ring PET scanners are covered from July 1, 2001, through December 31, However, as of January 1, 2002, full and partial ring scanners are covered. Beginning October 1, 2002, Medicare covers FDG PET for the determination of myocardial viability as a primary or initial diagnostic study prior to revascularization, or following an inconclusive SPECT. Studies performed by full and partial ring scanners are covered. Limitations: In the event a patient receives a SPECT test with inconclusive results, a PET scan may be covered. However, if a patient receives a FDG PET study with inconclusive results, a follow up SPECT test is not covered. National Coverage Determination (NCD) for FDG PET for Myocardial Viability ( ) PET for cardiac sarcoidosis Cardiac PET scanning may be MEDICALLY NECESSARY for the diagnosis of cardiac sarcoidosis in patients who are unable to undergo magnetic resonance imaging (MRI) scanning. Examples of patients 2

3 who are unable to undergo MRI include, but are not limited to, patients with pacemakers, automatic implanted cardioverter-defibrillators (AICDs), or other metal implants. Prior Authorization Information Commercial Members: Managed Care (HMO and POS) Prior authorization is NOT required. Commercial Members: PPO, and Indemnity Prior authorization is NOT required. Medicare Members: HMO Blue SM Prior authorization is NOT required. Medicare Members: PPO Blue SM Prior authorization is NOT required. CPT Codes / HCPCS Codes / ICD-9 Codes The following codes are included below for informational purposes. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member. A draft of future ICD-10 Coding related to this document, as it might look today, is included below for your reference. Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes CPT codes: Code Description Myocardial imaging, positron emission tomography (PET), metabolic evaluation Myocardial imaging, positron emission tomography (PET), perfusion; single study at rest or stress Myocardial imaging, positron emission tomography (PET), perfusion; multiple studies at rest and/or stress HCPCS Codes HCPCS codes: A9500 A9501 A9502 A9505 A9526 A9538 A9552 A9555 ICD-9 Diagnosis Codes ICD-9-CM Code Description Technetium tc-99m sestamibi, diagnostic, per study dose Technetium Tc-99m teboroxime, diagnostic, per study dose Technetium Tc-99m tetrofosmin, diagnostic, per study dose Thallium Tl-201 thallous chloride, diagnostic, per millicurie Nitrogen N-13 ammonia, diagnostic, per study dose, up to 40 millicuries Technetium Tc-99m pyrophosphate, diagnostic, per study dose, up to 25 millicuries Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries Rubidium Rb-82, diagnostic, per study dose, up to 60 millicuries diagnosis codes: Code Description Tuberculosis of other specified organs, confirmation unspecified Chagas' disease with heart involvement 135 Sarcoidosis 3

4 Thyrotoxicosis without mention of goiter or other cause, without mention of thyrotoxic crisis or storm Thyrotoxicosis without mention of goiter or other cause, with mention of thyrotoxic crisis or storm Beriberi Glycogenosis Other amyloidosis Mucopolysaccharidosis Friedreich's ataxia Myotonic muscular dystrophy Hereditary progressive muscular dystrophy Intermediate coronary syndrome Acute coronary occlusion without myocardial infarction Angina decubitus Prinzmetal angina Other and unspecified angina Coronary atherosclerosis of unspecified type of vessel, native or graft Coronary atherosclerosis of native coronary artery Coronary atherosclerosis of autologous vein bypass graft Coronary atherosclerosis of nonautologous biological bypass graft Coronary atherosclerosis of artery bypass graft Coronary atherosclerosis of unspecified bypass graft Coronary atherosclerosis of native coronary artery of transplanted heart Coronary atherosclerosis of bypass graft (artery) (vein) of transplanted heart Coronary atherosclerosis of unspecified type of vessel, native or graft Aneurysm of coronary vessels Dissection of coronary artery Other aneurysm of heart Chronic total occlusion of coronary artery Coronary atherosclerosis due to lipid rich plaque Coronary atherosclerosis due to calcified coronary lesion Other specified forms of chronic ischemic heart disease Endomyocardial fibrosis Hypertrophic obstructive cardiomyopathy Other hypertrophic cardiomyopathy Obscure cardiomyopathy of Africa Endocardial fibroelastosis Other primary cardiomyopathies Alcoholic cardiomyopathy Nutritional and metabolic cardiomyopathy Cardiomyopathy in other diseases classified elsewhere Unspecified secondary cardiomyopathy Takotsubo syndrome Heart disease, unspecified Congenital obstructive anomalies of heart, not elsewhere classified ICD-10 Diagnosis Codes ICD-10-CM Diagnosis codes: Code Description A18.84 Tuberculosis of heart B57.0 Acute Chagas' disease with heart involvement B57.2 Chagas' disease (chronic) with heart involvement 4

5 D86.85 Sarcoid myocarditis E05.90 Thyrotoxicosis, unspecified without thyrotoxic crisis or storm E05.91 Thyrotoxicosis, unspecified with thyrotoxic crisis or storm E51.12 Wet beriberi E74.02 Pompe disease E76.01 Hurler's syndrome E76.02 Hurler-Scheie syndrome E76.03 Scheie's syndrome E76.1 Mucopolysaccharidosis, type II E Morquio A mucopolysaccharidoses E Morquio B mucopolysaccharidoses E Morquio mucopolysaccharidoses, unspecified E76.22 Sanfilippo mucopolysaccharidoses E76.29 Other mucopolysaccharidoses E76.3 Mucopolysaccharidosis, unspecified E76.8 Other disorders of glucosaminoglycan metabolism E76.9 Glucosaminoglycan metabolism disorder, unspecified E85.4 Organ-limited amyloidosis G11.1 Early-onset cerebellar ataxia G71.0 Muscular dystrophy G71.11 Myotonic muscular dystrophy I20.0 Unstable angina I20.1 Angina with documented spasm I20.8 Other forms of angina I24.0 Acute coronary thrombosis not resulting in myocardial infarction I25.10 Atherosclerotic heart disease of native coronary artery without angina I Atherosclerotic heart disease of native coronary artery with unstable angina I Atherosclerotic heart disease of native coronary artery with angina with I documented spasm Atherosclerotic heart disease of native coronary artery with other forms of angina I Atherosclerotic heart disease of native coronary artery with unspecified angina I25.3 Aneurysm of heart I25.5 Ischemic cardiomyopathy I25.6 Silent myocardial ischemia I Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable angina I Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina with documented spasm I Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina I Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina I Atherosclerosis of autologous vein coronary artery bypass graft(s) with unstable angina I Atherosclerosis of autologous vein coronary artery bypass graft(s) with angina with documented spasm I Atherosclerosis of autologous vein coronary artery bypass graft(s) with other forms of angina I Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina I Atherosclerosis of autologous artery coronary artery bypass graft(s) with unstable 5

6 angina I Atherosclerosis of autologous artery coronary artery bypass graft(s) with angina with documented spasm I Atherosclerosis of autologous artery coronary artery bypass graft(s) with other forms of angina I Atherosclerosis of autologous artery coronary artery bypass graft(s) with unspecified angina I Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unstable angina I Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with angina with documented spasm I Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with other forms of angina I Atherosclerosis of nonautologous biological coronary artery bypass graft(s) with unspecified angina I Atherosclerosis of native coronary artery of transplanted heart with unstable angina I Atherosclerosis of native coronary artery of transplanted heart with angina with documented spasm I Atherosclerosis of native coronary artery of transplanted heart with other forms of angina I Atherosclerosis of native coronary artery of transplanted heart with unspecified angina I Atherosclerosis of bypass graft of coronary artery of transplanted heart with unstable angina I Atherosclerosis of bypass graft of coronary artery of transplanted heart with angina with documented spasm I Atherosclerosis of bypass graft of coronary artery of transplanted heart with other forms of angina I Atherosclerosis of bypass graft of coronary artery of transplanted heart with unspecified angina I Atherosclerosis of other coronary artery bypass graft(s) with unstable angina I Atherosclerosis of other coronary artery bypass graft(s) with angina with documented spasm I Atherosclerosis of other coronary artery bypass graft(s) with other forms of angina I Atherosclerosis of other coronary artery bypass graft(s) with unspecified angina I Atherosclerosis of coronary artery bypass graft(s) without angina I Atherosclerosis of native coronary artery of transplanted heart without angina I Atherosclerosis of bypass graft of coronary artery of transplanted heart without angina 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 I42.0 Dilated cardiomyopathy I42.1 Obstructive hypertrophic cardiomyopathy I42.2 Other hypertrophic cardiomyopathy I42.3 Endomyocardial (eosinophilic) disease I42.4 Endocardial fibroelastosis I42.5 Other restrictive cardiomyopathy I42.6 Alcoholic cardiomyopathy 6

7 I42.7 Cardiomyopathy due to drug and external agent I42.9 Cardiomyopathy, unspecified I43 Cardiomyopathy in diseases classified elsewhere I50.1 Left ventricular failure I51.81 Takotsubo syndrome I51.9 Heart disease, unspecified I52 Other heart disorders in diseases classified elsewhere Q24.8 Other specified congenital malformations of heart Description Positron emission tomography (PET) scans are based on the use of positron-emitting radionuclide tracers, which simultaneously emit 2 high energy photons in opposite directions. These photons can be simultaneously detected (referred to as coincidence detection) by a PET scanner, consisting of multiple stationary detectors that encircle the thorax. Compared to single photon emission computed tomography (SPECT) scans, coincidence detection offers greater spatial resolution. Cardiac PET scanning initially focused on 2 distinct clinical situations: 1) myocardial perfusion scanning as a technique of identifying perfusion defects, which in turn reflect coronary artery disease (CAD); and 2) assessment of myocardial viability in patients with left ventricular (LV) dysfunction as a technique to determine candidacy for a revascularization procedure. A third potential clinical use related to CAD is being evaluated, use of cardiac PET in the measurement of myocardial blood flow and blood flow reserve. Cardiac PET is also being studied in the evaluation of coronary artery inflammation. Note: This policy only addresses the use of radiotracers detected with the use of dedicated PET scanners. Radiotracers such as fluorodeoxyglucose (FDG) may be detected using SPECT cameras, a hybrid PET/SPECT procedure that may be referred to as FDG-SPECT or molecular coincidence detection. This technique is not discussed in this document. Summary Evidence from the medical literature supports the use of PET scanning to assess myocardial viability in patients with severe LV dysfunction who are being considered for revascularization. Results of primary studies and recommendations from specialty societies conclude that PET scanning is at least as good as, and likely superior, to SPECT scanning for this purpose. For assessing myocardial perfusion in patients with suspected coronary artery disease, PET scanning is less likely than SPECT scanning to provide indeterminate results. Therefore, PET scanning is also useful in patients with an indeterminate SPECT scan, as well as in patients whose body habitus is likely to result in indeterminate SPECT scans, for example patients with moderate to severe obesity. For patients who are undergoing a workup for cardiac sarcoidosis, MRI is the preferred initial test. However, for patients who are unable to undergo MRI, such as patients with a metal implant, PET scanning is the preferred test. Policy History Date Action 9/2014 New references added from BCBSA National medical policy. 7/2014 Updated Coding section with ICD10 procedure and diagnosis codes, effective 10/ /2014 Coding information clarified 1/2014 Clarified coding information 10/2013 New references from BCBSA National medical policy. 8/2013 PET for myocardial viability for Medicare Advantage clarified. PET for cardiac sarcoidosis for Medicare Advantage clarified. 11/2011-4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates. 1/2012 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 10/2011 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ 7

8 Transplantation. 7/2011 Reviewed - Medical Policy Group - Hematology and Oncology. 4/2011 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 1/2011 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 11/2010 Reviewed - Medical Policy Group - Gastroenterology, Nutrition and Organ Transplantation. 9/2010 Reviewed - Medical Policy Group - Hematology and Oncology. 4/2010 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 3/2010 Reviewed - Medical Policy Group - Allergy and ENT/Otolaryngology. 1/2010 Reviewed - Medical Policy Group - Neurology and Neurosurgery. 1/2010 BCBSA National medical policy review. Changes to policy statements. 11/2009 BCBSA National medical policy review. Changes to policy statements. 4/2009 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 4/2009 BCBSA National medical policy review. Changes to policy statements. 4/2008 Reviewed - Medical Policy Group - Cardiology and Pulmonology. 4/2008 BCBSA National medical policy review. 4/2007 Reviewed - Medical Policy Group - Cardiology and Pulmonology. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines References 1. FDA. PET drugs - current good manufacturing practice (CGMP), 12/10/2009. Available online at: Last accessed June FDA. PET drugs - current good manufacturing practice (CGMP) (small entity compliance guide), 08/2011. Available online at: Last accessed June Diamond GA, Forrester JS, Hirsch M et al. Application of conditional probability analysis to the clinical diagnosis of coronary artery disease. J Clin Invest 1980; 65(5):

9 4. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). PET myocardial profusion imaging for the detection of coronary artery disease clinical assessment. TEC Assessments 1995; Volume 10, Tab Beanlands RS, Chow BJ, Dick A et al. CCS/CAR/CANM/CNCS/CanSCMR joint position statement on advanced noninvasive cardiac imaging using positron emission tomography, magnetic resonance imaging and multidetector computed tomographic angiography in the diagnosis and evaluation of ischemic heart disease--executive summary. Can J Cardiol 2007; 23(2): Jaarsma C, Leiner T, Bekkers SC et al. Diagnostic performance of noninvasive myocardial perfusion imaging using single-photon emission computed tomography, cardiac magnetic resonance, and positron emission tomography imaging for the detection of obstructive coronary artery disease: a meta-analysis. J Am Coll Cardiol 2012; 59(19): Parker MW, Iskandar A, Limone B et al. Diagnostic accuracy of cardiac positron emission tomography versus single photon emission computed tomography for coronary artery disease: a bivariate meta-analysis. Circ Cardiovasc Imaging 2012; 5(6): Bateman TM, Heller GV, McGhie AI et al. Diagnostic accuracy of rest/stress ECG-gated Rb-82 myocardial perfusion PET: comparison with ECG-gated Tc-99m sestamibi SPECT. J Nucl Cardiol 2006; 13(1): Merhige ME, Breen WJ, Shelton V et al. Impact of myocardial perfusion imaging with PET and (82)Rb on downstream invasive procedure utilization, costs, and outcomes in coronary disease management. J Nucl Med 2007; 48(7): Siebelink HM, Blanksma PK, Crijns HJ et al. No difference in cardiac event-free survival between positron emission tomography-guided and single-photon emission computed tomography-guided patient management: a prospective, randomized comparison of patients with suspicion of jeopardized myocardium. J Am Coll Cardiol 2001; 37(1): Slart RH, Bax JJ, de Boer J et al. Comparison of 99mTc-sestamibi/18FDG DISA SPECT with PET for the detection of viability in patients with coronary artery disease and left ventricular dysfunction. Eur J Nucl Med Mol Imaging 2005; 32(8): Knesaurek K, Machac J. Comparison of 18F SPECT with PET in myocardial imaging: a realistic thorax-cardiac phantom study. BMC Nucl Med 2006; 6: Ziadi MC, Dekemp RA, Williams KA et al. Impaired myocardial flow reserve on rubidium-82 positron emission tomography imaging predicts adverse outcomes in patients assessed for myocardial ischemia. J Am Coll Cardiol 2011; 58(7): Murthy VL, Naya M, Foster CR et al. Improved cardiac risk assessment with noninvasive measures of coronary flow reserve. Circulation 2011; 124(20): Murthy VL, Naya M, Foster CR et al. Association between coronary vascular dysfunction and cardiac mortality in patients with and without diabetes mellitus. Circulation 2012; 126(15): Herzog BA, Husmann L, Valenta I et al. Long-term prognostic value of 13N-ammonia myocardial perfusion positron emission tomography added value of coronary flow reserve. J Am Coll Cardiol 2009; 54(2): Schindler TH, Schelbert HR, Quercioli A et al. Cardiac PET imaging for the detection and monitoring of coronary artery disease and microvascular health. JACC Cardiovasc Imaging 2010; 3(6): Beanlands RS, Ziadi MC, Williams K. Quantification of myocardial flow reserve using positron emission imaging the journey to clinical use. J Am Coll Cardiol 2009; 54(2): Gould KL, Johnson NP, Bateman TM et al. Anatomic Versus Physiologic Assessment of Coronary Artery Disease: Role of Coronary Flow Reserve, Fractional Flow Reserve, and Positron Emission Tomography Imaging in Revascularization Decision-Making. J Am Coll Cardiol 2013; 62(18): Sharma S. Cardiac imaging in myocardial sarcoidosis and other cardiomyopathies. Curr Opin Pulm Med 2009; 15(5): Youssef G, Leung E, Mylonas I et al. The use of 18F-FDG PET in the diagnosis of cardiac sarcoidosis: a systematic review and metaanalysis including the Ontario experience. J Nucl Med 2012; 53(2): Klocke FJ, Baird MG, Lorell BH et al. ACC/AHA/ASNC guidelines for the clinical use of cardiac radionuclide imaging--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASNC Committee to Revise the 9

10 1995 Guidelines for the Clinical Use of Cardiac Radionuclide Imaging). J Am Coll Cardiol 2003; 42(7): Earls JP, White RD, Woodard PK et al. ACR Appropriateness Criteria(R) chronic chest pain--high probability of coronary artery disease. J Am Coll Radiol 2011; 8(10): Authors/Task Force Members: McMurray JJ, Adamopoulos S, Anker SD et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J 2012; 33(14): Ishida Y, Yoshinaga K, Miyagawa M et al. Recommendations for (18)F-fluorodeoxyglucose positron emission tomography imaging for cardiac sarcoidosis: Japanese Society of Nuclear Cardiology Recommendations. Ann Nucl Med 2014; 28(4): Centers for Medicare and Medicaid Services (CMS). Coverage and Related Claims Processing Requirements for Positron Emission Tomography (PET) Scans for Breast Cancer and Revised Coverage Conditions for Myocardial Viability, Transmittal AB Available online at: Last accessed June