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Date Printed: June 24, 2017: 11:31 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-33000-35

Original Effective Date: 09/15/16

Reviewed: 08/25/16

Revised: 00/00/00

Subject: Transcatheter Mitral Valve Repair (TMVR)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates      
           

DESCRIPTION:

Transcatheter mitral valve repair (TMVR) is a potential alternative to surgical therapy for mitral regurgitation (MR). MR is a common valvular heart disease that can result from either a primary structural abnormality of the mitral valve (MV) complex or a secondary dilatation of an anatomically normal MV due to a dilated left ventricle caused by ischemic or dilated cardiomyopathy. Surgical therapy may be underutilized suggesting that there is an unmet need for less invasive procedures for MV repair.

Transcatheter approaches have been investigated to address the unmet need for less invasive mitral valve MV repair, particularly among patients who face prohibitively high surgical risks due to their ages or comorbidities. MV repair devices under development address various components of the MV complex and generally are performed on the beating heart without the need for cardiopulmonary bypass. Approaches to MV repair include direct leaflet repair, repair of the mitral annulus via direct annuloplasty, or indirect repair based on the annulus’s proximity to the coronary sinus. There are also devices in development to counteract ventricular remodeling, and systems designed for complete MV replacement via catheter.

One device that undertakes direct leaflet repair, the MitraClip® Clip Delivery System, was approved through the U.S. Food and Drug Administration (FDA) premarket approval process for the treatment of severe symptomatic MR due to a primary abnormality of the MV (degenerative mitral regurgitation) in patients who are considered at prohibitive risk for surgery. Additional devices for transcatheter MV repair that use various approaches are currently in development.

POSITION STATEMENT:

Transcatheter mitral valve repair (TMVR) with a device cleared by the FDA for use in mitral valve repair meets the definition of medical necessity for members with symptomatic, degenerative mitral regurgitation who are considered at risk for open surgery based on the presence of:

• Society for Thoracic Surgeons predicted mortality risk of 12% or greater; and/or

• Logistic EuroSCORE of 20% or greater.

Transcatheter mitral valve repair is considered experimental or investigational in all other situations. The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

0345T

Transcatheter mitral valve repair percutaneous approach via the coronary sinus

33418

Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; initial prosthesis

33419

Transcatheter mitral valve repair, percutaneous approach, including transseptal puncture when performed; additional prosthesis(es) during same session (List separately in addition to code for primary procedure)

ICD-10 Diagnoses Codes That Support Medical Necessity:

I34.0-I34.9

Nonrheumatic mitral valve disorders

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Transcatheter Mitral Valve Repair (TMVR) (20.33) located at cms.gov.

DEFINITIONS:

Logistic EuroSCORE: European System for Cardiac Operative Risk Evaluation is a risk model which allows the calculation and predicts mortality according to the logistic regression equation. An online logistic EuroSCORE interactive calculator can be found at: http://www.euroscore.org/calc.html.

Society for Thoracic Surgeons (STS) Predicted Mortality Risk: a model that predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic, clinical variables and comparing outcomes across institutions with different patient populations. An online STS risk calculator can be found at: http://riskcalc.sts.org/stswebriskcalc/#/calculate.

RELATED GUIDELINES:

02-33000-33, Transcatheter Pulmonary Valve Implantation

OTHER:

None applicable.

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Reference Policy Manual 2.02.30 Transcatheter Mitral Valve Repair, May 2016.
  2. Centers for Medicare & Medicaid Services (CMS), National Coverage Determination (NCD) for Transcatheter MITRAL VALVE Repair (TMVR) (20.33), April 2015.
  3. Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology, European Association for Cardio-Thoracic Surgery, Vahanian A, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J. Oct 2012;33(19):2451-2496.
  4. Lesevic H, Sonne C, Braun D, et al. Acute and midterm outcome after MitraClip therapy in patients with severe mitral regurgitation and left ventricular dysfunction. Am J Cardiol. Sep 1 2015;116(5):749-756.
  5. Minha S, Torguson R, Waksman R. Overview of the 2013 Food and Drug Administration Circulatory System Devices Panel meeting on the MitraClip Delivery System. Circulation. Aug 20 2013;128(8):864-868.
  6. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. Jun 10 2014;129(23):2440-2492.
  7. O'Gara PT, Calhoon JH, Moon MR, et al. Transcatheter therapies for mitral regurgitation: a professional society overview from the American College of Cardiology, The American Association for Thoracic Surgery, Society for Cardiovascular Angiography and Interventions Foundation, and The Society of Thoracic Surgeons. J Thorac Cardiovasc Surg. Mar 2014;147(3):837-849.
  8. Philip F, Athappan G, Tuzcu EM, et al. MitraClip for severe symptomatic mitral regurgitation in patients at high surgical risk: a comprehensive systematic review. Catheter Cardiovasc Interv. Oct 1 2014;84(4):581-590.
  9. Puls M, Lubos E, Boekstegers P, et al. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J. Feb 21 2016;37(8):703-712.
  10. U.S. Food and Drug Administration (FDA), Summary of Safety and Effectiveness Data: Mitral Valve Repair Device-MitraClip® Clip Delivery System, 2013; accessed at fda.gov 07/14/16.
  11. Velazquez EJ, Samad Z, Al-Khalidi HR, et al. The MitraClip and survival in patients with mitral regurgitation at high risk for surgery: A propensity-matched comparison. Am Heart J. Nov 2015;170(5):1050-1059.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/25/16.

GUIDELINE UPDATE INFORMATION:

09/15/16

New Medical Coverage Guideline.

Date Printed: June 24, 2017: 11:31 AM