Prior Authorization Review Panel MCO Policy Submission

Transcription

1 Prior Authorization Review Panel MCO Policy Submission A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review. Plan: Aetna Better Health Submission Date: 11/01/2018 Policy Number: 0558 Effective Date: Revision Date: Policy Name: Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Type of Submission Check all that apply: New Policy* Revised Policy Annual Review No Revisions *All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below: CPB 0558 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Policy is new to Aetna Better Health of Pennsylvania. Name of Authorized Individual (Please type or print): Signature of Authorized Individual: Dr. Bernard Lewin, M.D.

2 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 1 of 16 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) Number: 0558 Policy *Please see amendment forpennsylvaniamedicaid at theend of this CPB. I. Aetna considers percutaneous transluminal septal myocardial ablation (PTSMA) by alcohol-induced septal branch occlusion medically necessary for hypertrophic obstructive cardiomyopathy (HOCM) in adults when all of the following criteria are met: Policy History Last Review: 11/10/2017 Effective: 08/14/2001 Next Review: 06/07/2018 Review History Definitions A. Member has severe symptoms (e.g., dyspnea, angina pectoris, [pre]syncope, palpitations or heart failure) for at least 6 months despite optimal drug therapy (e.g., beta-blockers, calcium-antagonists), dual chamber pacing therapy and/or ineffective previous surgical myotomy/myectomy; and B. Member is classified as New York Heart Association class III or IV (see below); and Additional Information Clinical Policy Bulletin Notes C. Member has a classical, asymmetric subaortic HOCM identified by echocardiography, and not a mid-

3 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 2 of 16 ventricular, a concealed membranous subaortic stenosis, nor supravalvular form; and D. Echocardiography shows left ventricular wall thickness of greater than 13 mm in adults in the absence of another cause for left ventricular hypertrophy; 15 mm in an athlete; and E. Member has systolic anterior motion of the mitral valve on echocardiography; and F. Member has a resting left ventricular outflow tract (LVOT) gradient of greater than 30 mm Hg or a stressed gradient of greater than 60 mm Hg, or member has less severe symptoms and LVOT of greater than 50 mm Hg at rest or greater than 100 mm Hg under stress; and G. Member does not have coronary artery disease that would preclude performance of the procedure. II. Aetna considers percutaneous transluminal septal myocardial ablation experimental and investigational for all other indications because of insufficient evidence of its safety and effectiveness. Background Hypertrophic obstructive cardiomyopathy (HOCM), also known as idiopathic hypertrophic subaortic stenosis, is a primary, sometimes familial and genetically determined myocardial hypertrophy with an incidence of about 0.2 %. About 25 % of the patients have dynamic left ventricular outflow tract (LVOT) obstruction, which usually develops during puberty and increases in severity until the age of 18 to 20 years. Not infrequently, HOCM is diagnosed for the first time in the elderly. Echocardiography is the primary method for diagnosing HOCM. This condition is characterized by a super-normally contracting left ventricle, asymmetric septal hypertrophy, which

4 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 3 of 16 affects mainly the interventricular septum, increased ventricular wall thickness (left ventricular wall thickness of greater than 13 mm in adults in the absence of another cause for left ventricular hypertrophy; 15 mm in an athlete), and systolic anterior motion of the mitral valve. Although patients with hypertrophic cardiomyopathy usually have supernormal ejection fractions, they have thickened and poorly compliant left ventricles in which left ventricular filling pressure is markedly elevated and probably is responsible for most of the symptoms. Cardiac hypertrophy is associated with LVOT obstruction in only a minority of HOCM patients. The LVOT gradient is generated by systolic anterior motion of a mitral valve leaflet and its coaptation with the interventricular septum. Left ventricular outflow tract obstruction does not generally increase during exercise because of adequate venous return, but it often worsens or becomes apparent in the immediate post-exercise period. Maneuvers that decrease preload or afterload or increase myocardial contractility, such as stress, dehydration, and sudden adoption of an erect posture often induce symptoms. The significance of the LVOT gradient has been debated, but it is now generally accepted that it is an important determinant of the clinical course. Asymptomatic adult patients probably do not require therapy or risk stratification studies, unless there is a malignant family history of sudden death or occupational need (airline pilot). Management decisions are dominated by the need to address sometimes disabling symptoms of dyspnea, angina pectoris, stress-induced syncope, palpitations or heart failure, and risk of sudden death. Treatment of symptomatic patients with HOCM aims at reduction of the LVOT gradient and improvement of diastolic filling either by pharmacological therapy with negative inotropic drugs (beta-blockers, calciumantagonists), permanent DDD pacemaker therapy (i.e., dualchamber, dual-pacing, dual-sensing), or surgical myotomy/myectomy.

5 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 4 of 16 At least 10 % of patients with severe HCOM are unresponsive to medical therapy or report severe side effects of optimum doses of drugs. Successful DDD pacing at the apex of the right ventricle induces a paradoxic motion of the interventricular septum away from the mitral valve, reducing LVOT obstruction. Long-term studies have uniformly confirmed that DDD pacing can reduce LVOT gradient and improve severe drug-refractory symptoms in most patients with HOCM, obviating the need for cardiac surgery. A large European study has demonstrated that when follow-up was sufficiently long to allow adaptive changes and to eliminate carryover effects, DDD pacing conferred substantial symptomatic and hemodynamic benefits. As some of the beneficial effects of DDD pacing become apparent after prolonged pacing, it is important to allow sufficient time for chronic DDD pacemaker therapy. Left ventricular myotomy and myectomy (Morrow's procedure) has been the standard therapy for patients with severe symptoms (New York Heart Association (NYHA) functional class III to IV) that persist despite adequate pharmacotherapy and DDD pacing. Using an aortic root approach, this involves surgically removing enough muscle from the septum to sufficiently widen the outflow tract. The procedure improves or eliminates symptoms and LVOT gradient in 90 % of patients. The success of the procedure and the operative mortality are very much dependent on the skill and experience of the surgeon but may be as low as 1 to 2 %. Complications include heart block, ventricular septal defect, 1 to 2 % annual mortality during follow-up, late aortic valve incompetence, and LV dysfunction. Sometimes, a prosthetic mitral valve replacement must be done to eliminate systolic anterior motion and LVOT obstruction, but the patient requires life-long anti-coagulation and is subject to the risk of prosthetic malfunction. In 1994, as an alternative to surgery, non-surgical percutaneous transluminal septal myocardial ablation (PTSMA) by alcohol-induced septal branch occlusion was

6 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 5 of 16 introduced to decrease LVOT gradient and improve symptoms in patients with HOCM. This method was substantially improved by the introduction of echocardiographic guidance in With this guidance, the reduction in the LVOT gradient is optimized and ablation of inappropriate areas can be avoided. Consequently, the hemodynamic results and symptoms are improved, and the incidence of complications is reduced. The most common procedural complication is the development of high-grade trifascicular block necessitating implantation of a permanent pacemaker in 25 % of patients. Other complications include death, ventricular arrhythmias, and coronary artery dissection. Percutaneous transluminal septal myocardial ablation involves transcatheter selection of 1 or 2 small septal branches of the left anterior descending artery, threading a small, short, lowpressure angioplasty balloon into position to occlude the artery, and the instillation of absolute alcohol into the myocardium. The resultant localized myocardial infarction reduces the amount of septal myocardium, opening up the LVOT. Compared with surgical myectomy, the literature shows that PTSMA has the advantage of being minimally invasive, easily repeated, and with relatively low major morbidity/mortality risk for patients with co-morbid conditions. In one study, 70 % of patients during short-term follow-up showed impressive clinical improvement as well as diminution of intra-ventricular pressure gradient and a marked increase in maximal workload during exercise testing. During a 12-month follow-up period, there was a significant decrease of functional class, a reduced rate of syncope, and a reduced degree of mitral insufficiency. Exercise capacity, oxygen uptake and the cardiac index increased, intra-ventricular gradient, the end diastolic pressure of the left ventricle and the left atrial size decreased. Additionally, there was a decrease in the septal thickness with increase in the cross-sectional area of the outflow tract. PET examination showed an ablation-induced local myocardial defect. There was also evidence for

7 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 6 of 16 improved diastolic function. Electrophysiological and Holter monitor studies indicated no increased arrhythmogenicity. The in-hospital mortality rate amounts to about 1.8 % and in 15 % of patients a second PTSMA is necessary. There appears to be little doubt in the literature that favorable morphologic and functional results can be achieved by PTSMA, and that short-term follow-up studies show clinical and objective improvement, as well as further gradient reduction due to left ventricular remodeling. Currently, randomized, prospective studies of larger patient series are being conducted to compare the short- and long-term effects of PTSMA with the major treatment options (e.g., pharmacologic therapy, myotomy/myectomy, mitral valve replacement, pacemaker implantation). The outcomes of these studies will be needed to determine PTSMA s ultimate role in the treatment of HOCM, as well as provide guidance concerning the optimal treatment of patients with HOCM. The American Heart Association and the American College of Cardiology have no position statements on this procedure. An assessment by the National Institute of Clinical Excellence (NICE, 2003) concluded that current evidence on the safety and efficacy of non-surgical reduction of the myocardial septum appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance. Percutaneous transluminal septal myocardial ablation is best performed in centers with experience with this procedure. Patients treated with PTSMA should be entered into a registry of these procedures. Zhang and colleagues (2011) retrospectively summarized the effect of non-medical therapies for pediatric patients with HOCM. From November 2008 to June 2010, 4 children with drug-refractory HOCM were admitted to the authors' hospital.

8 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 7 of 16 Their ages were 14, 7, 9 and 6 years old, respectively. Their body weights were 38, 17, 21.5 and 17 kg, respectively. Before operation, the LVOT gradients were 60, 147, 58 and 114 mm Hg (1 mm Hg = kpa), respectively; mitral regurgitation (MR) areas were 2.2, 7.3 cm(2) and 2.9 cm(2), respectively, except that it was trivial in 1 case. Percutaneous transluminal septal myocardial ablation was performed in case 1 and 2. Septal myectomy (SM) was performed in case 3 and 4. Follow-up was first performed right after operation or before discharge, then 1 month, 3 months, 6 months, and 12 months after operation, and then once-yearly. The follow-up period was 1 to 18 (9.3 +/- 8.1) months. All patients experienced relieved symptoms; 3 of them had their NYHA functional class improved except case 2. Echocardiography revealed that LVOT gradients right after operations were 38, 79, 20 and 0 mm Hg, respectively, suggesting significant improvement of LVOT obstruction in all patients. During follow-up, case 2 suffered from recurrence of LVOT obstruction, while the other 3 cases showed sustained relief. In the last follow-up, the LVOT gradients of the 4 patients were 19, 168, 16 and 0 mm Hg, respectively. Echocardiography also revealed that MRs of all patients were significantly reduced, even in case 2 whose LVOT gradient rebounded, with no recurrence during followup. Severe complications were absent, such as ventricular septum perforation, cardiac tamponade, ventricular tachycardia or ventricular fibrillation. No one suffered from complete heart block. Transient complete right bundle branch block (CRBBB) was observed in case 1 after PTSMA and converted to intra-ventricular block after 1 month. Complete left bundle branch block (CLBBB) was present in both case 3 and 4, who received SM. In case 4, it converted to intraventricular block after 1 month while in case 3 CLBBB persisted. The authors concluded that the initial experience showed that PTSMA and SM were safe and effective for drugrefractory symptomatic HOCM children, with satisfactory shortterm results. They stated that further studies are needed to evaluate the long-term results and complications.

9 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 8 of 16 Appendix The New York Heart Association (NYHA) classification is as follows: Class Class I Classification Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Class II Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III 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. Class IV 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. CPT Codes / HCPCS Codes / ICD-10 Codes Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+": Code Code Description ICD-10 codes will become effective as of October 1, 2015:

10 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical Poli... Page 9 of 16 Code Code Description There is no specific CPT code for percutaneous transluminal septal myocardial ablation: CPT codes covered if selection criteria are met: Percutaneous transcatheter septal reduction therapy (eg, alcohol septal ablation) including temporary pacemaker insertion when performed Other HCPCS codes related to the CPB: : C1886 Catheter, extravascular tissue ablation, any modality (insertable) ICD-10 codes covered if selection criteria are met: I42.1 Obstructive hypertrophic cardiomyopathy The above policy is based on the following references: 1. Nagueh SF, Lakkis NM, Middleton KJ, et al. Changes in left ventricular diastolic function 6 months after nonsurgical septal reduction therapy for hypertrophic obstructive cardiomyopathy. Circulation. 1999;99(3): Faber L, Seggewiss H, Gleichmann U. Percutaneous transluminal septal myocardial ablation in hypertrophic obstructive cardiomyopathy: Results with respect to intraprocedural myocardial contrast echocardiography. Circulation. 1998;98(22): Nagueh SF, Lakkis NM, He ZX, et al. Role of myocardial contrast echocardiography during nonsurgical septal reduction therapy for hypertrophic obstructive cardiomyopathy. J Am Coll Cardiol. 1998;32(1):

11 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 10 of Kuhn HJ. Induced septal infarction/nonsurgical septal reduction for hypertrophic obstructive cardiomyopathy. Circulation. 1998;97(7): Seggewiss H, Gleichmann U, Faber L, et al. Percutaneous transluminal septal myocardial ablation in hypertrophic obstructive cardiomyopathy: Acute results and 3-month follow-up in 25 patients. J Am Coll Cardiol. 1998;31(2): Lerakis S, Sheahan RG, Stouffer GA. Hypertrophic cardiomyopathy: Presentation and pathophysiology. Am J Med Sci. 1997;314(5): Knight C, Kurbaan AS, Seggewiss H, et al. Nonsurgical septal reduction for hypertrophic obstructive cardiomyopathy: Outcome in the first series of patients. Circulation. 1997;95(8): Sigwart U. Nonsurgical myocardial reduction for hypertrophic obstructive cardiomyopathy. Lancet. 1995;346: Lakkis NM, Nagueh SF, Kleiman NS, et al. Echocardiography-guided ethanol septal reduction for hypertrophic obstructive cardiomyopathy. Circulation. 1998;98: Spirito P. Alcohol septal ablation in the management of obstructive hypertrophic cardiomyopathy. Ital Heart J. 2000;1(11): Maron BJ. Role of alcohol septal ablation in treatment of obstructive hypertrophic cardiomyopathy. Lancet. 2000;355(9202): Seggewiss H. Current status of alcohol septal ablation for patients with hypertrophic cardiomyopathy. Curr Cardiol Rep. 2001;3(2): Cheng TO. Transcatheter alcohol septal ablation for hypertrophic obstructive cardiomyopathy. Circulation. 1999;100(11): Kim JJ. Improvement in exercise capacity and exercise blood pressure response after transcoronary alcohol

12 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 11 of 16 ablation therapy of septal hypertrophy in hypertrophic cardiomyopathy. Am J Cardiol. 1999;83(8): No authors listed. Alcohol injections replace surgery for patients with hypertrophic cardiomyopathy. Harv Heart Lett. 1999;9(5): Kuhn H. Transcoronary ablation of septal hypertrophy (TASH): A new treatment option for hypertrophic obstructive cardiomyopathy. Z Kardiol. 2000;89(Suppl 4):IV41-IV Rubin DN. Percutaneous transluminal septal myocardial ablation. Curr Cardiol Rep. 2000;2(2): Faber L. Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: Long term follow up of the first series of 25 patients. Heart. 2000;83(3): Seggewiss H. Current status of alcohol septal ablation for patients with hypertrophic cardiomyopathy. Curr Cardiol Rep. 2001;3(2): Qin JX, Shiota T, Lever HM, et al. Outcome of patients with hypertrophic obstructive cardiomyopathy after percutaneous transluminal septal myocardial ablation and septal myectomy surgery. J Am Coll Cardiol. 2001;38 (7): Mutlak D, Gruberg L, Reisner S, et al. Non-surgical myocardial reduction in hypertrophic obstructive cardiomyopathy. Isr Med Assoc J. 2002;4(2): Jiang T, Wu X, Jia C, et al. Percutaneous transluminal septal myocardial ablation in patients with hypertrophic obstructive cardiomyopathy. Chin Med J (Engl). 2002;115 (1): Kovacic JC, Muller D. Hypertrophic cardiomyopathy: State-of-the-art review, with focus on the management of outflow obstruction. Intern Med J. 2003;33(11): National Institute for Clinical Excellence (NICE). Interventional procedure overview of non-surgical reduction of myocardial septum. London, UK: NICE; November 2003.

13 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 12 of Li ZQ, Cheng TO, Zhang WW, et al. Percutaneous transluminal septal myocardial ablation for hypertrophic obstructive cardiomyopathy: The Chinese experience in 119 patients from a single center. Int J Cardiol. 2004;93 (2-3): Veselka J, Prochazkova S, Duchonova R, et al. Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: Lower alcohol dose reduces size of infarction and has comparable hemodynamic and clinical outcome. Catheter Cardiovasc Interv. 2004;63(2): National Institute for Clinical Excellence (NICE). Nonsurgical reduction of myocardial septum. Interventional Procedure Guidance 40. London, UK: NICE; February van der Lee C, ten Cate FJ, Geleijnse ML, et al. Percutaneous versus surgical treatment for patients with hypertrophic obstructive cardiomyopathy and enlarged anterior mitral valve leaflets. Circulation. 2005;112 (4): Zeng Z, Wang F, Dou X, et al. Comparison of percutaneous transluminal septal myocardial ablation versus septal myectomy for the treatment of patients with hypertrophic obstructive cardiomyopathy--a meta analysis. Int J Cardiol. 2006;112(1): Murphy RT, Ratliff NB, Lever HM, Kapadia SR. Use of percutaneous transluminal septal myocardial ablation for relief of outflow tract obstruction in cardiac amyloidosis: A novel therapeutic target. Catheter Cardiovasc Interv. 2006;68(4): Seggewiss H, Rigopoulos A, Welge D, et al. Long-term follow-up after percutaneous septal ablation in hypertrophic obstructive cardiomyopathy. Clin Res Cardiol. 2007;96(12): Hosokawa Y, Takano H, Ohno T, et al. Impact of percutaneous transluminal septal myocardial ablation on refractory paroxysmal atrial fibrillation in patients with

14 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 13 of 16 hypertrophic obstructive cardiomyopathy. Angiology. 2008;59(3): Welge D, Seggewiss H, Fassbender D, et al. Long-term follow-up after percutaneous septal ablation in hypertrophic obstructive cardiomyopathy. Dtsch Med Wochenschr. 2008;133(39): van der Lee C, Scholzel B, ten Berg JM, et al. Usefulness of clinical, echocardiographic, and procedural characteristics to predict outcome after percutaneous transluminal septal myocardial ablation. Am J Cardiol. 2008;101(9): Faber L, Welge D, Hering D, et al. Percutaneous septal ablation after unsuccessful surgical myectomy for patients with hypertrophic obstructive cardiomyopathy. Clin Res Cardiol. 2008;97(12): Llamas-Esperón GA, Loera Pinales A, Sandoval Navarrete S, et al. Percutaneous transluminal septal myocardial ablation in patients with obstructive septal hypertrophic myocardiopathy. Acute results and 3-year follow-up. Arch Cardiol Mex. 2009;79(1): Gersh BJ, Maron BJ, Bonow RO, et al.; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Failure Society of America; Heart Rhythm Society; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons ACCF/AHA guideline for the diagnosis and treatment of hypertrophic cardiomyopathy: Executive summary: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;124(24): Zhang X, Li YF, Xie B, et al. Non-drug treatment for hypertrophic obstructive cardiomyopathy in children. Zhonghua Er Ke Za Zhi. 2011;49(5):

15 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 14 of Jensen MK, Almaas VM, Jacobsson L, et al. Long-term outcome of percutaneous transluminal septal myocardial ablation in hypertrophic obstructive cardiomyopathy: A Scandinavian multicenter study. Circ Cardiovasc Interv. 2011;4(3): Jensen MK, Havndrup O, Hassager C, et al. Survival and sudden cardiac death after septal ablation for hypertrophic obstructive cardiomyopathy. Scand Cardiovasc J. 2011;45(3): Chen S, Yuan J, Zhang J, et al. Assessment of atrial conduction abnormalities in patients with hypertrophic cardiomyopathy before and one year after alcohol septal ablation. Cardiology. 2012;123(4): Chen S, Duan F, Yuan J, et al. Effect of septal ablation on regional diastolic dysfunction and diastolic asynchrony in patients with hypertrophic obstructive cardiomyopathy: A follow-up study using speckle tracking echocardiography. Echocardiography. 2013;30(5): Wild C. Perkutane transluminale septale Myokardablation/ PTSMA bei PatientInnen mit hyperthroph-obstruktiver Kardiomyopathie. [Percutaneous transluminal septal myocardial ablation (PTSMA) in hypertrophic obstructive cardiomyopathy (HOCM)]. Decision Support Document 71. Vienna, Austria: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBIHTA); Marin MS. Nonpharmacologic treatment of outflow obstruction in hypertrophic cardiomyopathy. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed April Rigopoulos AG, Seggewiss H. Twenty years of alcohol septal ablation in hypertrophic obstructive cardiomyopathy. Curr Cardiol Rev. 2016;12(4): Maekawa Y, Akita K, Tsuruta H, et al. Significant reduction of left atrial volume concomitant with clinical improvement after percutaneous transluminal septal myocardial ablation for drug-refractory hypertrophic

16 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 15 of 16 obstructive cardiomyopathy, and its precise detection with multidetector CT. Open Heart. 2016;3(1):e

17 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) - Medical Clinical P... Page 16 of 16 Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change. Copyright Aetna Inc.

18 AETNA BETTER HEALTH OF PENNSYLVANIA Amendment to Aetna Clinical Policy Bulletin Number: 0558 Percutaneous Transluminal Septal Myocardial Ablation (PTSMA) There are no amendments for Medicaid. new 11/01/2018