Transcatheter Tricuspid Valve Interventions Form

1 Transcatheter Tricuspid Valve Interventions Medical Policy New Policy Effective: 10/1/2025 Policy Number: UM1003POL Approval Date: Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy) Description The tricuspid valve directs blood flow from the right atrium into the right ventricle. It closes the right atrium (upper chamber) where blood enters from the body, then opens to allow blood to flow to the right ventricle (lower chamber), while preventing backflow when pumped out of the ventricle. Tricuspid regurgitation (leaking) or stenosis (narrowing) may result from an improperly functioning tricuspid valve. Primary tricuspid valve disease is rare. The underlying etiology can be of either congenital or of acquired nature. Surgical treatment is often reserved for advanced stages of tricuspid disease when dysfunction, particularly in patients with congestive heart failure, has led to symptomatic right heart failure. Patients undergoing tricuspid repair or replacement procedures tend to be at higher risk with poorer outcome. The standard for treating tricuspid valve disease is surgical annuloplasty. Tricuspid annuloplasty (valve repair), reconstruction or replacement via transcatheter approach is being studied as a treatment for tricuspid regurgitation. Devices for transcatheter tricuspid valve repair, reconstruction, and replacement are in development. Transcatheter tricuspid valve repair or replacement generally includes right heart catheterization, temporary pacemaker insertion and selective right ventricular or right atrial angiography during the procedure.
Transcatheter caval valve implantation (CAVI) is an investigational technique proposed to relieve the symptoms of severe tricuspid regurgitation (eg, ascites, dyspnea, fatigue, lower extremity edema) without repairing or replacing the tricuspid valve. This is accomplished by implanting a valve in the inferior vena cava (IVC) alone or in combination with a second valve in the superior vena cava (SVC) to redirect the regurgitant blood flow from the failing tricuspid valve. There are no FDA-approved CAVI devices available for general use.
American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for the management of patients with valvular heart disease (Otto et al., 2020) make the following recommendations regarding transcatheter valve therapies does not address the transcatheter approach for tricuspid valve replacement. European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) joint guideline for the management of valvular heart disease (Vahanian et al., 2022) indicates that transcatheter treatment of symptomatic secondary severe tricuspid regurgitation has a IIb recommendation which indicates the procedure may be considered in inoperable patients at a heart valve center with expertise in the treatment of tricuspid valve disease. This level of recommendation indicates that the usefulness or efficacy of this approach is less well established by evidence/opinion.

2 Line of Business Commercial:
• Refer to criteria under the Policy section in this medical policy. Medicaid – BeHealthy: • Refer to criteria under the Policy section in this medical policy. • There are no MassHealth guidelines for Transcatheter Tricuspid Valve Interventions. Medicare: • Health New England follows National Coverage Analysis (NCA) for Transcatheter Tricuspid Valve Replacement (TTVR) until 12/31/2025 • Health New England follows National Coverage Determination (NCD) 20.37 for Transcatheter Tricuspid Valve Replacement (TTVR) effective 1/1/2026. • Health New England follows National Coverage Article (NCA) (CAG-00468N) for Transcatheter Edge-to- Edge Repair for Tricuspid Valve Regurgitation (T-TEER). • Refer to criteria under the Policy section in this medical policy for Transcatheter Tricuspid Valve Reconstruction and Transcatheter Caval Valve Implantation (CAVI). Policy I. Transcatheter tricuspid heart valve repair, reconstruction, or replacement: A. For Commercial and Medicaid line of business, above procedures are considered EXPERIMENTAL and INVESTIGATIONAL due to insufficient evidence of efficacy. B. For Medicare, refer to NCD 20.37 for Transcatheter Tricuspid Valve Replacement (TTVR) and NCA for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER). https://www.cms.gov/medicare-coverage-database/search.aspx II. Transcatheter Caval Valve Implantation (CAVI) for all lines of business is considered EXPERIMENTAL and INVESTIGATIONAL due to insufficient evidence of efficacy. Coding Guidance

3 Code Description PA 0545T Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus reconstruction device, percutaneous approach
E&I 0569T Transcatheter tricuspid valve repair, percutaneous approach; initial prosthesis PA for Medicare E&I for Commercial and MassHealth 0570T Transcatheter tricuspid valve repair, percutaneous approach; each additional prosthesis during same session (List separately in addition to code for primary procedure)
PA for Medicare E&I for Commercial and MassHealth 0646T Transcatheter tricuspid valve implantation/replacement (TTVI) with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed
PA for Medicare E&I for Commercial and MassHealth 0805T Transcatheter superior and inferior vena cava prosthetic valve implantation (ie, caval valve implantation [CAVI]); percutaneous femoral vein approach
E&I 0806T Transcatheter superior and inferior vena cava prosthetic valve implantation (ie, caval valve implantation [CAVI]); open femoral vein approach
E&I CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply. References NCD 20.37 for Transcatheter Tricuspid Valve Replacement (TTVR). NCD - Transcatheter Tricuspid Valve Replacement (TTVR) (20.37) NCA (CAG-00467N) for Transcatheter Tricuspid Valve Replacement (TTVR). NCA - Transcatheter Tricuspid Valve Replacement (TTVR) (CAG-00467N) NCA (CAG-00468N) Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER). NCA - Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) (CAG-00468N)

4 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Otto et al., 2020. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000923 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Vahanian et al., 2022. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Valvular-Heart-Disease-Guidelines Lurz P, Orban M, Besler C, et al. Clinical characteristics, diagnosis, and risk stratification of pulmonary hypertension in severe tricuspid regurgitation and implications for transcatheter tricuspid valve repair. Eur Heart J. 2020;41:2785–95. https://pubmed.ncbi.nlm.nih.gov/32176280/ Taramasso M, Hahn RT, Alessandrini H, et al. The international multicenter TriValve registry: which patients are undergoing transcatheter tricuspid repair? JACC Cardiovasc Interv. 2017;10:1982–90. https://pubmed.ncbi.nlm.nih.gov/28982563/ Asmarats L, Puri R, Latib A, et al. Transcatheter tricuspid valve interventions: landscape, challenges, and future directions. J Am Coll Cardiol. 2018;71:2935–56. https://pubmed.ncbi.nlm.nih.gov/29929618/ Hayes, Inc. Evolving Evidence Review Aug 20, 2024. Evoque Tricuspid Valve Replacement System (Edwards Lifesciences Corp.) for Tricuspid Regurgitation. Hayes, Inc. Emerging Technology Report Jun 13, 2024. TriClip G4 System (Abbott Medical) Transcatheter Tricuspid Valve Repair for Tricuspid Regurgitation. Policy Implementation Approved by the Medical and Pharmacy Policy Committee Kate McIntosh MD MBA Chief Medical Officer Saad Usmani MD MBA Medical Director Date Update 04/2025 New Policy 07/2025 For Medicare line of business, added NCD effective 1/1/2026 for Transcatheter Tricuspid Valve Replacement. NCA (CAG-00467N) for Transcatheter Tricuspid Valve Replacement will be used up until 12/31/2025. Added reference to NCA for Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER). Reference updated. Medical Criteria Disclaimer

5 Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England 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). Health New England 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 Health New England, as some programs exclude coverage for services or supplies that Health New England 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. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.