403 Form

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Medical Policy Transcatheter Pulmonary Valve Implantation Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 403 BCBSA Reference Number: 7.01.131 (For Plan internal use only) NCD/LCD: N/A Related Policies
Transcatheter Aortic Valve Implantation for Aortic Stenosis #392 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Transcatheter pulmonary valve implantation with a Food and Drug Administration-approved valve is considered MEDICALLY NECESSARY for individuals with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:

• Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation
• Individuals with native or patched RVOT with at least moderate pulmonic regurgitation
• 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
• Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg).

Transcatheter pulmonary valve implantation is considered INVESTIGATIONAL for all other indications.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient

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Commercial Managed Care (HMO and POS) This procedure is performed in the inpatient setting Commercial PPO and Indemnity This procedure is performed in the inpatient setting Medicare HMO BlueSM This procedure is performed in the inpatient setting Medicare PPO BlueSM This procedure is performed in the inpatient setting CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

The following codes are included below for informational purposes only; this is not an all-inclusive list.

The above medical necessity criteria MUST be met for the following codes to be covered for Commercial Members: Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue: CPT Codes CPT codes: Code Description 33477 Transcatheter pulmonary valve implantation, percutaneous approach, including pre- stenting of the valve delivery site, when performed

Description Congenital Heart Disease Congenital heart disease, including tetralogy of Fallot, pulmonary atresia, and transposition of the great arteries, is generally treated by surgical repair at an early age. This 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 long periods of follow-up. 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 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. The optimal timing of these interventions is not well understood.3,

Summary Description 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.

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Summary of Evidence For individuals who have a history of congenital heart disease and current right ventricular outflow tract (RVOT) obstruction who receive transcatheter pulmonary valve implementation (TPVI) with a U.S. Food and Drug Administration (FDA) approved device and indication, the evidence includes a systematic review of retrospective comparative studies,and prospective, interventional, noncomparative studies, and a multicenter registry of 2,476 individuals who underwent TPV replacement with a Melody (82%) or Sapien (18%) valve between July 2005 and March 2020. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related mortality and morbidity. Overall, the evidence suggests that TPVI is associated with high rates of short-term technical success and improvements in heart failure-related symptoms and hemodynamic parameters. Most valves have demonstrated competent functioning by Doppler echocardiography at 6- to 12-month follow-ups. Publications with longer follow-up have reported stent fractures in up to 26% of patients; however, most stent fractures did not require reintervention. Studies with follow-up extending to a maximum of 8 years post-procedure have suggested that the functional and hemodynamic improvements are durable. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have a history of congenital heart disease and current RVOT obstruction who receive TPVI with a non-FDA-approved device or indication, the evidence includes case series. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, hospitalizations, and treatment-related mortality and morbidity. There is limited evidence on the off-label use of TPVI including the use of a non- FDA-approved valve or use of an approved valve for a non-FDA-approved indication. The published case series enrolled relatively few patients and are heterogeneous regarding devices used and indications for TPVI. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Policy History Date Action 8/2025 Annual policy review. References updated. Policy statements unchanged. 8/2024 Annual policy review. References added. Policy statements unchanged. 5/2024 Clarified prior authorization table 8/2023 Annual policy review. References added. Policy statements unchanged. 8/2022 Annual policy review. References added. Minor editorial refinements to policy statements; intent unchanged. 8/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 8/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 8/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 10/2018 Annual policy review. Policy criteria revised. Prior authorization information clarified.
Effective 10/1/2018. 9/2016 Annual policy review. FDA approval information updated. References added.
7/2016 Annual policy review. New references added. 1/2016 Clarified coding information. 12/2014 Annual policy review. New references added. 2/2014 Annual policy review. New references added. Clarified coding information.
6/2013 Annual policy review. No change to policy statement. Effective 6/1/2013. 12/1/2012 New policy describing ongoing coverage and non-coverage. Effective 12/1/2012. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines

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Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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 17255818
3. 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
4. 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
5. 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. Accessed May 1, 2025.
6. 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
7. 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
8. Batra AS, McElhinney DB, Wang W, et al. Cardiopulmonary exercise function among patients undergoing transcatheter pulmonary valve implantation in the US Melody valve investigational trial. Am Heart J. Feb 2012; 163(2): 280-7. PMID 22305848
9. 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 May 3, 2025.
10. 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 25459038
11. 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
12. Food and Drug Administration. Conditions for Approval for an HDE: Medtronic Melody Transcatheter Pulmonary Valve (Model PB 10) and Medtronic Ensemble Transcatheter Valve Delivery System (NU10) (H080002). 2010; https://www.accessdata.fda.gov/cdrh_docs/pdf8/H080002A.pdf. Accessed May 6, 2025.
13. Food and Drug Administration. Summary of Safety and Effectiveness Data: MelodyTM Transcatheter Pulmonary Valve, models PB1016 and PB1018; EnsembleTM Transcatheter Valve Delivery System 2017; https://www.accessdata.fda.gov/cdrh_docs/pdf14/p140017s005b.pdf. Accessed May 5, 2025.
14. Jones TK, McElhinney DB, Vincent JA, et al. Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial. Circ Cardiovasc Interv. Jan 2022; 15(1): e010852. PMID 34930015
15. 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
16. Food and Drug Administration. Summary of Safety and Effectiveness: Harmony Transcatheter Pulmonary Valve. 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200046B.pdf Accessed May 2, 2025.

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17. 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
18. 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
19. 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
20. Boshoff DE, Cools BL, Heying R, et al. Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label?. Catheter Cardiovasc Interv. May 2013; 81(6): 987-95. PMID 22887796
21. Cheatham SL, Holzer RJ, Chisolm JL, et al. The Medtronic Melody® transcatheter pulmonary valve implanted at 24-mm diameter--it works. Catheter Cardiovasc Interv. Nov 01 2013; 82(5): 816-23. PMID 23359563
22. Veldurthy S, Shrivastava D, Majeed F, et al. Incidence of Infective Endocarditis Post-TPVR with MELODY Valve in Pediatric Patients: A Systematic Review and Meta-Analysis. Curr Cardiol Rev. 2025; 21(1): e1573403X324878. PMID 39289937
23. 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
24. 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
25. 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-
26. PMID 22075927
27. 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
28. 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
29. 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
30. 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
31. 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