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Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy

Last Review Date: March 13, 2020

Number: MG.MM.SU.40aC4

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Property of EmblemHealth. All rights reserved. The treating physician or primary care provider must submit to EmblemHealth the clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization. The clinical review criteria expressed below reflects how EmblemHealth determines whether certain services or supplies are medically necessary. EmblemHealth established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). EmblemHealth expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by EmblemHealth, as some programs exclude coverage for services or supplies that EmblemHealth considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. EmblemHealth Services Company LLC, ("EmblemHealth") has adopted the herein policy in providing management, administrative and other services to HIP Health Plan of New York, HIP Insurance Company of New York, Group Health Incorporated and GHI HMO Select, related to health benefit plans offered by these entities. All of the aforementioned entities are affiliated companies under common control of EmblemHealth Inc.

Definition Alcohol-induced septal ablation (AISA) (aka transcoronary ablation of septal hypertrophy [TASH]) -- an interventional catheter-based cardiology procedure, which is a nonsurgical alternative to myectomy. Under imaging guidance, ethanol is injected through a coronary artery supplying the heart in order to induce a septal infarct. The ethanol causes septal scarring that becomes thinner after a period of several weeks resulting in a larger ventricular outflow tract and reduction of symptoms.

Guideline Adult members (of at least 21 years of age) with moderate to severe symptomatic hypertrophic obstructive cardiomyopathy (HOCM) are eligible for AISA coverage when the following criteria are met; all:

1. Presence of asymmetric septal hypertrophy (> 13 mm [> 15 in athlete]) with systolic anterior motion (SAM) of the mitral valve

2. Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV) refractory to medical therapy

3. Left ventricular outflow tract (LVOT) gradient 50 mm Hg at rest or with provocation (exercise). 4. Absence of concomitant heart disease requiring surgical treatment 5. Presence of a patent septal perforator suitable for procedure (size, location)

Limitations/Exclusions 1. Alcohol septal ablation is not considered medically necessary for members who are asymptomatic with normal exercise tolerance or whose symptoms are controlled or minimalized on optimal medical therapy. 2. Requests for AISA (as a myomectomy alternative) for Class IIb members with severe drug refractory symptoms and LVOT obstruction will be reviewed on a case-by- case basis.

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The Stages of Heart Failure: NYHA Classification

Class Patient Symptoms

I

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or dyspnea

(shortness of breath).

II

Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation or

dyspnea.

III Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation or dyspnea.

IV Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.

Class Objective Assessment

A

No objective evidence of cardiovascular disease. No symptoms and no limitation in ordinary physical activity.

B

Objective evidence of minimal cardiovascular disease. Mild symptoms and slight limitation during ordinary activity.

Comfortable at rest.

C

Objective evidence of moderately severe cardiovascular disease. Marked limitation in activity due to symptoms, even

during less-than-ordinary activity. Comfortable only at rest.

D

Objective evidence of severe cardiovascular disease. Severe limitations. Experiences symptoms even while at rest.

Applicable Procedure Codes

93583 Percutaneous transcatheter septal reduction therapy (eg, alcohol septal ablation) including temporary pacemaker insertion when performed

93799 Unlisted cardiovascular service or procedure

Applicable ICD-10 Codes

I42.1 Obstructive hypertrophic cardiomyopathy

References

American Heart Association. Classes of Heart Failure. 2017. . Accessed March 13, 2020. Hess OM, Sigwart U. New treatment strategies for hypertrophic obstructive cardiomyopathy; alcohol ablation of the septum: the new gold standard? J Am Coll Cardiol. 2004;44:2054-2055. Gersh BJ, Bonow, Robert O, Fifer, Michael A., et al. CCF/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. 2011. . Accessed March 13, 2020.

Alcohol Septal Ablation for Hypertrophic Cardiomyopathy Last review: Mar. 13, 2020 Page 3 of 3

Maron BJ, McKenna WJ, Danielson GK, et al. ACC)/ESC clinical expert consensus document on hypertrophic cardiomyopathy. A report of the ACC Foundation Task Force on Clinical Expert Consensus Documents and the ESC Committee for Practice Guidelines. 2003. . Accessed April 13, 2018.

Specialty-matched clinical peer review.

Talreja DR, Nishimura RA, Edwards WD, et al. Alcohol septal ablation versus surgical septal myectomy: comparison of effects on atrioventricular conduction tissue. J Am Coll Cardiol. 2004;44:2329-2332.

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