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PG0108 Transcatheter Valve Replacement Transcatheter Valve Replacement Policy Number: PG0108 ADVANTAGE | ELITE | HMO Last Review: 05/24/2018 INDIVIDUAL MARKETPLACE | PROMEDICA MEDICARE PLAN | PPO GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. SCOPE X Professional _ Facility DESCRIPTION Transcatheter aortic valve replacement (TAVR) is a procedure used to treat aortic stenosis for patients who are high-risk or too sick for open-heart surgery. This less invasive procedure allows a new valve to be inserted within the native, diseased aortic valve. The TAVR procedure can be performed through two different approaches - transfemoral (through an incision in the leg) or transapical (through an incision in the chest between the ribs). TAVR is performed on a beating heart and does not require cardio-pulmonary bypass. Transcatheter mitral valve repair (TMVR), also referred to as percutaneous mitral valve repair (PMVR), is a procedure used to treat mitral regurgitation which is the most common type of heart valve insufficiency in the country. The MitraClip® Mitral Valve Repair System (Abbott Vascular Inc.) and the Carillon Mitral Contour System (Cardiac Dimensions Inc.) are minimally invasive devices that are percutaneously implanted for repair of a damaged or leaking mitral valve (MV) in the heart. The goal of this procedure is to restore normal mitral valve function without need for open heart surgery. Transcatheter pulmonary valve replacement (TPVR), also referred to as percutaneous pulmonary valve implantation (PPVI), is a minimally invasive heart surgery in patients with right ventricular outflow tract (RVOT) defects. The procedure involves the deployment and placement of a pulmonary valve prosthesis via a catheter inserted into a vein. The purpose of PPVI is to delay the need for surgical repair of a dysfunctional RVOT. The Medtronic Melody® Transcatheter Pulmonary Valve and Ensemble Delivery System received FDA approval under the Humanitarian Device Exemption (HDE) program on January 25, 2010. Paravalvular leaks may occur as a complication of aortic or mitral valve replacement surgery, when the seal between the vessel wall and the valve becomes separated. Regurgitation of blood may occur, and large leaks could lead to heart failure or endocarditis. Percutaneous transcatheter repair of paravalvular leaks has been successfully performed; however, there are currently no FDA-approved devices for this indication. POLICY TAVR (33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369) does not require prior authorization for Paramount participating providers. TMVR (33418, 33419, 0345T) does not require prior authorization for Paramount participating providers. TPVR (33477) does not require prior authorization for Paramount participating providers. PG0108 – 12/15/2020 Percutaneous transcatheter repair of paravalvular leak of mitral or aortic valve (93590-93592) is non-covered for HMO, PPO, Individual Marketplace, & Elite/ProMedica Medicare Plan. Percutaneous transcatheter repair of paravalvular leak of mitral or aortic valve (93590-93592) does not require prior authorization for Paramount participating providers when treating Advantage members. COVERAGE CRITERIA AORTIC VALVE: TAVR (33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369) is considered medically necessary for patients with severe, symptomatic aortic stenosis. In 2011, ProMedica Toledo Hospital became one of 150 hospitals to receive approval to perform TAVR. A multidisciplinary team of interventional cardiologists and cardiothoracic surgeons will evaluate each patient for eligibility for the TAVR procedure. When approved by the multidisciplinary team as medically necessary, Paramount will cover TAVR when performed via a transfemoral or a transapical approach, using a U.S. Food and Drug Administration (FDA) approved device (i.e., Edwards SAPIEN Transcatheter Heart Valve [Edwards Lifesciences, LLC, Irvine, CA]). MITRAL VALVE: TMVR (33418, 33419, 0345T) is considered medically necessary for high-risk patients who have moderate or severe MV regurgitation but are not candidates for conventional open MV repair surgery. PULMONARY VALVE: TPVR (33477) is considered medically necessary for patients with RVOT dysfunction who meet the selection criteria for the valve, whose conduits are larger than 16 millimeters (mm) and smaller than 22 mm, and who cannot undergo or would like to delay open heart surgical pulmonary valve placement. HMO, PPO, Individual Marketplace, Elite/ProMedica Medicare Plan Percutaneous transcatheter repair of paravalvular leak of mitral or aortic valve is non-covered. Advantage Percutaneous transcatheter repair of paravalvular leak of mitral or aortic valve using an FDA approved device is covered when it is utilized in accordance with FDA labeling and it has been determined by a heart team, including a cardiac surgeon, to be at high or greater risk for open mitral or aortic surgical therapy. CODING/BILLING INFORMATION The appearance of a code in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES 33361 Transcatheter aortic valve replacement/insertion (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach 33362 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach 33363 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach 33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy) 33366 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy) PG0108 – 12/15/2020 33367 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (e.g., femoral vessels) (List separately in addition to code for primary procedure) 33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure) 33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (e.g., aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure) 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) 33477 Transcatheter pulmonary valve implantation, percutaneous approach including pre-stenting of the valve delivery site, when performed 93590 Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, mitral valve 93591 Percutaneous transcatheter closure of paravalvular leak; initial occlusion device, aortic valve 93592 Percutaneous transcatheter closure of paravalvular leak; each additional occlusion device (List separately in addition to code for primary procedure) 0345T Transcatheter mitral valve repair percutaneous approach via the coronary sinus ICD-10-CM CODES I34.0 Nonrheumatic mitral (valve) insufficiency I34.1 Nonrheumatic mitral (valve) prolapse I34.2 Nonrheumatic mitral (valve) stenosis I34.8 Other nonrheumatic mitral valve disorders I34.9 Nonrheumatic mitral valve disorder, unspecified I35.0 Non-rheumatic aortic (valve) stenosis I35.1 Non-rheumatic aortic (valve) insufficiency I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency I35.8 Other nonrheumatic aortic valve disorders I35.9 Nonrheumatic aortic valve disorder, unspecified REVISION HISTORY EXPLANATION ORIGINAL EFFECTIVE DATE: 06/01/2012 01/14/14: Deleted CPT code 0256T. Added CPT codes 33361, 33362, 33363, 33364, 33365, 33366, 33367, 33368, 33369. Changed name of policy from Transcatheter Aortic Valve Replacement – Endovascular Approach to Transcatheter Aortic Valve Replacement. ICD-10 Codes added from ICD-9 conversion. Policy reviewed and updated to reflect most current clinical evidence. Approved by Medical Policy Steering Committee as revised. 02/26/15: Policy title changed from Transcatheter Aortic Valve Replacement to Transcatheter Valve Replacement. Added Transcatheter Mitral Valve Repair (33418, 33419, 0345T, 424.0, I34.0, I34.1, I34.2, I34.8, I34.9) & Transcatheter Pulmonary Valve Replacement (0262T). Transcatheter Mitral Valve Repair (33418, 33419, 0345T) & Transcatheter Pulmonary Valve Replacement (0262T) covered without prior authorization for all product lines for Paramount participating providers per TAWG determination. Policy reviewed and updated to reflect most current clinical evidence per the Technology Assessment Working Group
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