Clinical Policy: Transmyocardial Laser Revascularization Reference Number: CP.MP.125

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1 Clinical Policy: Reference Number: CP.MP.125 Effective Date: 8/2016 Last Review Date: 8/2016 See Important Reminder at the end of this policy for important regulatory and legal information. Coding Implications Revision Log Description This policy describes the medical necessity guidelines for transmyocardial laser revascularization (TMLR). TMLR is a surgical technique designed to reduce angina pain in patients who have symptomatic coronary artery disease that is refractory to standard medical therapy and who are unsuitable candidates for traditional myocardial revascularization procedures (i.e., percutaneous coronary intervention or conventional coronary artery bypass graft.). Policy/Criteria I. It is the policy of health plans affiliated with Centene Corporation that transmyocardial laser revascularization is medically necessary for any of the following indications: A. As sole therapy in individuals whose angina is caused by areas of the heart not amenable to coronary artery bypass graft (CABG) surgery, percutaneous transluminal coronary angioplasty (PTCA)/stenting and coronary atherectomy and who meet all of the following: 1. New York Heart Association functional Class III or IV angina refractory to standard medical management, including drug therapy at the maximum tolerated or maximum safe dosages; 2. Coronary anatomy is untreatable due to any of the following: a. Severe diffuse obstructive coronary artery disease, b. Lack of suitable coronary artery conduits for complete revascularization; 3. Areas of viable ischemic myocardium, as demonstrated by stress testing, which are not capable of being revascularized by direct coronary intervention; 4. Medically stable with no evidence of recent MI or unstable angina within the last 21 days; 5. Left ventricular ejection fraction is > 30%; B. As an adjunct to CABG in those individuals whose coronary anatomy precludes complete surgical revascularization to documented areas of ischemic myocardium; C. Individuals in whom complete revascularization may be achieved with CABG, but for whom the risk/benefit ratio of CABG is prohibitive. II. It is the policy of health plans affiliated with Centene Corporation that transmyocardial laser revascularization is not medically necessary for the following indications: A. TMLR using the percutaneous approach B. Totally endoscopic robot-assisted TMLR C. Individuals without angina or with Class I or II angina D. Individual with ejection fraction < 30% with or without insertion of an intra-aortic balloon pump E. Unstable angina/acute ischemia necessitating intravenous anti-anginal therapy Page 1 of 5

2 F. Acute evolving myocardial infarction or recent transmural or non-transmural myocardial infarction within last 21 days G. Cardiogenic shock defined as a systolic blood pressure less than 80 mm/hg or a cardiac index of less than 1.8L/min/m2 H. Uncontrolled ventricular or supraventricular tachyarrhythmias I. Decompensated congestive heart failure Background TMLR is typically performed through a left thoracotomy, which uses a high-energy laser beam to create 15 to 30 transmural channels from the epicardial to the endocardial surfaces through the left ventricular myocardium of the beating heart in diastole in an attempt to improve local perfusion to viable ischemic myocardial territories not being reached by diseased arteries. No cardiopulmonary bypass is needed. It is important to note that while this technique does not provide for increased life expectancy, it does result in a significant reduction in pain, a reduction in hospitalizations, and a resumption of some normal activities of daily living for most patients treated. With appropriate patient selection and perioperative management, TMLR is associated with a very low operative risk. A variety of randomized studies have consistently reported that TMLR, as a sole therapy in individuals with coronary artery disease who are not candidates for revascularization, is associated with a significant improvement in anginal symptoms. The Society of Thoracic Surgeons Practice Guideline on Transmyocardial Laser Revascularization (Bridges et al 2004) make the following recommendations: Transmyocardial Revascularization as Sole Therapy Patients with an ejection fraction greater than 0.30 and CCS class III or IV angina that is refractory to maximal medical therapy. These patients should have reversible ischemia of the left ventricular freewall and coronary artery disease corresponding to the regions of myocardial ischemia. In all regions of the myocardium, the coronary disease must not be amenable to CABG or percutaneous transluminal angioplasty either as a result of (1) severe diffuse disease, (2) lack of suitable targets for complete revascularization, or (3) lack of suitable conduits for complete revascularization (Class I, level of evidence: A). Transmyocardial Revascularization as an Adjunct to Coronary Artery Bypass Grafting Patients with angina (class I IV) in whom CABG is the standard of care who also have at least one accessible and viable ischemic region with demonstrable coronary artery disease that cannot be bypassed either because of (1) severe diffuse disease, (2) lack of suitable targets for complete revascularization, or (3) lack of suitable conduits for complete revascularization (Class IIA, level of evidence: B). Class I Class II * New York Heart Association Classification of Angina Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Patients with cardiac disease resulting in slight limitation of physical Page 2 of 5

3 Class III Class IV activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. Percutaneous myocardial revascularization (PMR) is a less-invasive modification of TMR. There is insufficient evidence in the published medical literature to demonstrate the safety, efficacy, and long-term outcomes of percutaneous myocardial revascularization (PMR). Coding Implications This clinical policy references Current Procedural Terminology (CPT ). CPT is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2015, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. CPT Description Codes Transmyocardial laser revascularization, by thoracotomy Transmyocardial laser revascularization, by thoracotomy; performed at the time of other open cardiac procedure(s) ICD-10-CM Diagnosis Codes that Support Coverage Criteria ICD-10-CM Description Code Other acute and subacute forms of ischemic heart disease Angina pectoris Coronary atherosclerosis Other specified forms of chronic ischemic heart disease Chronic ischemic heart disease, unspecified Reviews, Revisions, and Approvals Date Approval Date Policy adopted from Health Net NMP394 Transmyocardial Laser Revascularization 07/16 Page 3 of 5

4 References 1. Bridges CR, Horvath KA, Nugent WC, et al. The Society of Thoracic Surgeons practice guideline series: transmyocardial laser revascularization. Ann Thorac Surg 2004 Apr;77(4): Available at: cularization.pdf 2. Briones E, Lacalle JR, Marin-Leon I, Rueda JR. Transmyocardial laser revascularization versus medical therapy for refractory angina. Cochrane Database Syst Rev Feb 27;(2):CD Fihn SD, Blankenship JC, Alexander KP, et al ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2014;64(18): Institute for Clinical Systems Improvement (ICSI). Transmyocardial laser therapy for severe refractory angina. Bloomington, MN: ICSI; Soran O. Alternative therapy for medically refractory angina: Enhanced external counterpulsation and transmyocardial laser revascularization. Cardiol Clin. 2014;32(3): ACC/AHA/AATS/PCNA/SCAI/STS focused update of the guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines, and the American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2014;64(18):1929. Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, Page 4 of 5

5 contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. Note: For Medicare members, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs and LCDs should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at for additional information Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 5 of 5