Transcatheter Pulmonary Valve Implantation (TPVI) Form

1 Transcatheter Pulmonary Valve Implantation (TPVI) Medical Policy New Policy Effective: June 1, 2025 Policy Number: UM1045POL Approval Date: Line(s) of Business: Commercial Medicare Advantage Medicaid (BeHealthy) Description Congenital heart diseases, including tetralogy of Fallot, pulmonary atresia, and transposition of the great arteries, are generally treated by surgical repair at an early age. Procedure involves reconstruction of the right ventricular outflow tract (RVOT) and pulmonary valve using a surgical homograft or a bovine-derived valve conduit. These repairs are prone to development of pulmonary stenosis or regurgitation over time. Individuals living with congenital heart disease also face disparities in social determinants of health and the inability to obtain quality lifelong care for their condition, which can contribute to inequities in morbidity and mortality (1). Because individuals with surgically corrected congenital heart disease repair are living into adulthood, RVOT dysfunction following initial repair has become more common. Calcification of the RVOT conduit can lead to pulmonary stenosis, while aneurysmal dilatation can result in pulmonary regurgitation. RVOT dysfunction can lead to decreased exercise tolerance, potentially fatal arrhythmias, and/or irreversible right ventricular dysfunction (2). Treatment options for pulmonary stenosis are open surgery with valve replacement, balloon dilatation, or percutaneous stenting (2). The established interventions for pulmonary regurgitation are primarily surgical, either reconstruction of the RVOT conduit or replacement of the pulmonary valve.
Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to open surgical pulmonary valve replacement or reconstruction for right ventricular outflow tract (RVOT) obstruction. Percutaneous pulmonary valve replacement may be indicated for congenital pulmonary stenosis. Pulmonary stenosis or regurgitation in a patient with congenital heart disease who has previously undergone RVOT surgery are additional indications. Patients with prior congenital heart disease repair are at risk of needing repeated reconstruction procedures. 3/11/2025

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 Pulmonary Valve Implantation.

Medicare:

 Refer to criteria under the Policy section in this medical policy.

 Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Transcatheter Pulmonary Valve Implantation.

Policy

I. Transcatheter pulmonary valve implantation (TPVI) with a Food and Drug Administration-approved device (e.g., Harmony Transcatheter Pulmonary Valve (TPV) System, Melody Transcatheter Pulmonary Valve, and Sapien S3 Valve) is considered MEDICALLY NECESSARY for individuals with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation when ANY of the following criteria are met: A. Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation; OR B. Individuals with native or patched RVOT with at least moderate pulmonic regurgitation; OR C. Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); OR D. Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg).

II. Transcatheter pulmonary valve implantation for all other indications other than in criteria above is considered NOT MEDICALLY NECESSARY.

Coding Guidance

Code
Description
PA 33477 Transcatheter pulmonary valve implantation, percutaneous approach, including pre- stenting of the valve delivery site, when performed. YES

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

3

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

1. Lopez KN, Baker-Smith C, Flores G, et al. Addressing Social Determinants of Health and Mitigating Health Disparities Across the Lifespan in Congenital Heart Disease: A Scientific Statement From the American Heart Association. J Am Heart Assoc. Apr 19 2022; 11(8): e025358. PMID 35389228.

2. Khambadkone S, Nordmeyer J, Bonhoeffer P. Percutaneous implantation of the pulmonary and aortic valves: indications and limitations. J Cardiovasc Med (Hagerstown). Jan 2007; 8(1): 57 -61. PMID

4. McElhinney DB, Hellenbrand WE, Zahn EM, et al. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. Aug 03 2010; 122(5): 507-16. PMID 20644013.

5. Ribeiro JM, Teixeira R, Lopes J, et al. Transcatheter Versus Surgical Pulmonary Valve Replacement: A Systemic Review and Meta-Analysis. Ann Thorac Surg. Nov 2020; 110(5): 1751-1761. PMID 32268142.

6. Food and Drug Administration. Summary of Safety and Probable Benefit: Melody Transcatheter Pulmonary Valve and Ensemble Transcatheter Valve Delivery System. 2010; https://www.accessdata.fda.gov/cdrh_docs/pdf8/H080002b.pdf.

7. Zahn EM, Hellenbrand WE, Lock JE, et al. Implantation of the melody transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit early results from the u.s. Clinical trial. J Am Coll Cardiol. Oct 27 2009; 54(18): 1722-9. PMID 19850214.

8. Cheatham JP, Hellenbrand WE, Zahn EM, et al. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. Jun 02 2015; 131(22): 1960-70. PMID 25944758.

9. Armstrong AK, Balzer DT, Cabalka AK, et al. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. Nov 2014; 7(11): 1254-62. PMID

11. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Edwards SAPIEN XTTM Transcatheter Heart Valve. 2016; https://www.accessdata.fda.gov/cdrh_docs/pdf13/p130009s037b.pdf. Accessed April 25, 2024.

12. Gillespie MJ, McElhinney DB, Kreutzer J, et al. Transcatheter Pulmonary Valve Replacement for Right Ventricular Outflow Tract Conduit Dysfunction After the Ross Procedure. Ann Thorac Surg. Sep 2015; 100(3): 996-1002; discussion 1002-3. PMID 26190388.

4

11. Georgiev S, Ewert P, Eicken A, et al. Munich Comparative Study: Prospective Long-Term Outcome of the Transcatheter Melody Valve Versus Surgical Pulmonary Bioprosthesis With Up to 12 Years of Follow-Up. Circ Cardiovasc Interv. Jul 2020; 13(7): e008963. PMID 32600110.

12. Food and Drug Administration. Summary of Safety and Effectiveness: Harmony Transcatheter Pulmonary Valve. 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200046B.pdf.

13. Gillespie MJ, Bergersen L, Benson LN, et al. 5-Year Outcomes from the Harmony Native Outflow Tract Early Feasibility Study. JACC Cardiovasc Interv. Apr 12 2021; 14(7): 816-817. PMID 33826508.

14. Gillespie MJ, McElhinney DB, Jones TK, et al. 1-Year Outcomes in a Pooled Cohort of Harmony Transcatheter Pulmonary Valve Clinical Trial Participants. JACC Cardiovasc Interv. Aug 14 2023; 16(15): 1917-1928. PMID 37278682.

15. McElhinney DB, Cabalka AK, Aboulhosn JA, et al. Transcatheter Tricuspid Valve-in-Valve Implantation for the Treatment of Dysfunctional Surgical Bioprosthetic Valves: An International, Multicenter Registry Study. Circulation. Apr 19 2016; 133(16): 1582-93. PMID 26994123.

16. McElhinney DB, Zhang Y, Levi DS, et al. Reintervention and Survival After Transcatheter Pulmonary Valve Replacement. J Am Coll Cardiol. Jan 04 2022; 79(1): 18-32. PMID 34991785.

17. McElhinney DB, Zhang Y, Aboulhosn JA, et al. Multicenter Study of Endocarditis After Transcatheter Pulmonary Valve Replacement. J Am Coll Cardiol. Aug 10 2021; 78(6): 575-589. PMID 34353535.

18. McElhinney DB, Cheatham JP, Jones TK, et al. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. Dec 01 2011; 4(6): 602-14. PMID 22075927.

19. Boudjemline Y, Malekzadeh-Milani S, Patel M, et al. Predictors and outcomes of right ventricular outflow tract conduit rupture during percutaneous pulmonary valve implantation: a multicentre study. EuroIntervention. Jan 22 2016; 11(9): 1053-62. PMID 25244126.

20. Morray BH, McElhinney DB, Cheatham JP, et al. Risk of coronary artery compression among patients referred for transcatheter pulmonary valve implantation: a multicenter experience. Circ Cardiovasc Interv. Oct 01 2013; 6(5): 535-42. PMID 24065444.

21. Fraisse A, Assaidi A, Mauri L, et al. Coronary artery compression during intention to treat right ventricle outflow with percutaneous pulmonary valve implantation: incidence, diagnosis, and outcome. Catheter Cardiovasc Interv. Jun 01 2014; 83(7): E260-8. PMID 24619978.

22. Aboulhosn JA, Hijazi ZM, Kavinsky CJ, et al. SCAI position statement on adult congenital cardiac interventional training, competencies and organizational recommendations. Catheter Cardiovasc Interv. Sep 01 2020; 96(3): 643-650. PMID 32272495.

23. Stout KK, Daniels CJ, Aboulhosn JA, et al. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. Apr 02 2019; 73(12): 1494-1563. PMID 30121240.

5

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 01/2025 Initial policy date

Medical Criteria Disclaimer

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.