Transcatheter Pulmonary Valve Implantation

Policy ID: S-203-014

Section: Surgery

Effective Date: March 01, 2020

Revised Date: August 14, 2024

Revision Effective Date: November 04, 2024

Last Reviewed: September 17, 2024

Applies To: Commercial and Medicaid Expansion

Description

Transcatheter pulmonary valve implantation (TVPI) using United States Food and Drug Administration (U.S. FDA) approved devices is a minimally invasive alternative to surgical pulmonary valve replacement in children and adult individuals with significant right ventricular outflow tract (RVOT) conduit regurgitation or stenosis

Policy Application

All claims submitted under this policy's section will be processed according to the policy effective date and associated revision effective dates in effect on the date of processing, regardless of service date.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

TVPI using an United States FDA approved device or system may be considered medically necessary for adult or pediatric individuals with congenital heart disease and current RVOT, regurgitation or stenosis meeting ALL the following criteria:

Individual has existence of a full (circumferential) RVOT conduit that was equal to or greater than (≥) 16 mm in diameter when originally implanted and ONE or more of the following:
- Right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation
- Native or patched RVOT with at least moderate pulmonic regurgitation
- Right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg)
- Native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg)
- Progressive right ventricular dilation (greater than (>) 150ml/M2) with or without reduced RV ejection fraction and abnormal exercise stress testing
- Objective exercise intolerance and abnormal RV stress echocardiogram with or without the above noted findings.

TVPI not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Code

33477

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code 33477

I37.0

I37.1

I37.2

I37.8

I37.9

I97.0

I97.110

I97.130

I97.190

Q20.5

Q21.3

Q22.0

Q22.1

Q22.2

Q22.3

T82.01XA

T82.01XD

T82.01XS

T82.02XA

T82.02XD

T82.02XS

T82.03XA

T82.03XD

T82.03XS

T82.09XA

T82.09XD

T82.09XS

T82.221A

T82.221D

T82.221S

T82.222A

T82.222D

T82.222S

T82.223A

T82.223D

T82.223S

T82.228A

T82.228D

T82.228S

T82.857A

T82.857D

T82.857S

T82.897A

T82.897D

T82.897S

T82.9XXA

T82.9XXD

T82.9XXS

Z87.74

Z95.2

Z95.3

Z95.4

Professional Statements and Societal Positions Guidelines

Society for Cardiovascular Angiography and Interventions et al - 2015

The Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American College of Cardiology (ACC), and the Society of Thoracic Surgeons (2015) published a consensus-based report on operator and institutional requirements for transcatheter pulmonary valve implantation (TPVI). Recommendations to qualify for a TPVI program included 150 catheterizations per year, association with a surgical program, submission of all cases to a national registry, and, for individuals, 80 percent freedom from reintervention at one (1) year.

ND Committee Review

Internal Medical Policy Committee 1-22-2020 New Policy for ND

Internal Medical Policy Committee 3-17-2021 Revision

Revised description, and
Expanded indications.

Internal Medical Policy Committee 9-21-2021 Revision

Added statement: Covered Diagnosis Codes for Procedure Code 33477

Internal Medical Policy Committee 9-28-2022 Annual Review - no changes in criteria

Internal Medical Policy Committee 7-26-2023 Revision - Effective September 04, 2023

Added Professional Statements and Societal Positions; and
Updated criteria

Internal Medical Policy Committee 7-16-2024 Annual review - no changes in criteria

Added coverage statement; and
Added Policy Applications

Internal Medical Policy Committee 9-17-2024 Revision - Effective November 04, 2024

Updated verbiage throughout policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: S-203-014

Section: Surgery

Effective Date: March 01, 2020

Revised Date: June 26, 2023

Revision Effective Date: September 02, 2024

Last Reviewed: July 16, 2024

Archived Date: November 03, 2024

Applies To: Commercial and Medicaid Expansion

Description

Transcatheter pulmonary valve implantation (TVPI) using United States (U.S.) Food and Drug Administration (FDA) approved devices is a minimally invasive alternative to surgical pulmonary valve replacement in children and adult individuals with significant right ventricular outflow tract (RVOT) conduit regurgitation or stenosis

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Policy Application

TVPI using an U.S. FDA approved device or system may be considered medically necessary for adult or pediatric individuals with congenital heart disease and current RVOT, regurgitation or stenosis meeting ALL the following criteria:

Individual has existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted and ANY of the following:
- Right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation; or
- Native or patched RVOT with at least moderate pulmonic regurgitation; or
- Right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); or
- Native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); or
- Progressive right ventricular dilation (greater than 150ml/M2) with or without reduced RV ejection fraction and abnormal exercise stress testing; or
- Objective exercise intolerance and abnormal RV stress echocardiogram with or without the above noted findings; and

TVPI not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Code

33477

Diagnosis Codes

I37.0

I37.1

I37.2

I37.8

I37.9

I97.0

I97.110

I97.130

I97.190

Q20.5

Q21.3

Q22.0

Q22.1

Q22.2

Q22.3

T82.01XA

T82.01XD

T82.01XS

T82.02XA

T82.02XD

T82.02XS

T82.03XA

T82.03XD

T82.03XS

T82.09XA

T82.09XD

T82.09XS

T82.221A

T82.221D

T82.221S

T82.222A

T82.222D

T82.222S

T82.223A

T82.223D

T82.223S

T82.228A

T82.228D

T82.228S

T82.857A

T82.857D

T82.857S

T82.897A

T82.897D

T82.897S

T82.9XXA

T82.9XXD

T82.9XXS

Z87.74

Z95.2

Z95.3

Z95.4

Professional Statements and Societal Positions Guidelines

Society for Cardiovascular Angiography and Interventions et al - 2015

ND Committee Review

Internal Medical Policy Committee 1-22-2020 New Policy for ND

Internal Medical Policy Committee 3-17-2021 Revision

Revised description, and
Expanded indications.

Internal Medical Policy Committee 9-21-2021 Revision

Added statement: Covered Diagnosis Codes for Procedure Code 33477

Internal Medical Policy Committee 9-28-2022 Annual Review - no changes in criteria

Internal Medical Policy Committee 7-26-2023 Revision - Effective September 04, 2023

Added Professional Statements and Societal Positions
Updated criteria

Internal Medical Policy Committee 7-16-2024 Annual review - no changes in criteria

Added coverage statement; and
Added Policy Applications

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