Transcatheter Closure Devices for Septal Defects

Policy ID: S-152-025

Section: Surgery

Effective Date: November 01, 2019

Revised Date: October 16, 2020

Revision Effective Date: November 02, 2020

Last Reviewed: September 21, 2020

Description

Transcatheter percutaneous cardiac occlusion devices are for use in minimally invasive repair of cardiac septal defects. These defects can be congenital or acquired. These devices offer an alternative to conventional open heart surgery.

Criteria

A U.S. Food and Drug Administration (FDA) approved percutaneous septal occlusion device used according to labeling, may be considered medically necessary for ANY ONE of following cardiac septal defects:

Closure of a secundum atrial septal defect (ASD); or
Closure of a fenestrated septal opening as a result of the Fontan procedure; or
Closure of a patent ductus arteriosus (PDA); or
Closure of a complex ventricular septal defect (VSD); or
For individuals that are considered high risk for standard transarterial or transarterial surgical VSD closure due to anatomic conditions and overall medical condition; or
Closure of surgical shunts or collaterals.

A percutaneous septal occlusion device is contraindicated for use in individuals with ANY of the following:

Known to have local or generalized sepsis, or any systemic infection that cannot be successfully treated within one (1) month prior to device placement; or
Whose size or condition would cause the individual to be a poor candidate for cardiac catheterization; or
With the margins of the defect less than five (5) mm to the coronary sinus, AV valves and right upper lobe pulmonary vein; or
With thrombus at or near the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained unless the individual is protected with other embolic protection devices such as a vena cava filter; or
Whose anatomy would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins should a septal occluder be used; or
With an intra-cardiac mass or vegetation; or
Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin, successfully prior to device placement; or
Whose vasculature is inadequate to accommodate a septal occlusion device.

All other devices or uses are considered experimental and investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

93580

93581

93582

Transcatheter closure of patent foramen ovale (PFO) with a FDA approved device may be considered medically necessary in individuals 18 years of age or older, with a history of ischemic stroke presumed to be secondary to a paradoxical embolism, following a negative workup for other causes of ischemic stroke.

All other devices or uses are considered experimental/investigational and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

93580

Outpatient HCPCS (C Codes)

C1766

C1769

C1817

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 93580, 93581 and 93582

123.1	123.2	151.0	Q21.0	Q21.1	Q21.2	Q21.3
Q21.9	Q25.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 9-26-2019 New policy for ND

Internal Medical Policy Committee 9-21-2020 policy revision

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.

Section: Surgery

Effective Date: November 01, 2019

Revised Date: October 02, 2019

Last Reviewed: September 26, 2019

Archived Date: November 01, 2020

Description

Criteria

A percutaneous septal occlusion device may be considered medically necessary for ANY ONE of following cardiac septal defects:

Closure of a secundum atrial septal defect (ASD); or

Closure of a fenestrated septal opening as a result of the Fontan procedure; or
Closure of a patent ductus arteriosus (PDA); or
Closure of a complex ventricular septal defect (VSD); or
For individuals that are considered high risk for standard transarterial or transarterial surgical VSD closure due to anatomic conditions and overall medical condition; or
Closure of ostium secundum ASD in individuals with echocardiographic evidence of right ventricular overload.
A percutaneous septal occlusion device is contraindicated for use in individuals with ANY of the following:

Known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery; or
Known to have local or generalized sepsis, or any systemic infection that cannot be successfully treated within one (1) month prior to device placement; or
Whose size or condition would cause the individual to be a poor candidate for cardiac catheterization; or
With the margins of the defect less than five (5) mm to the coronary sinus, AV valves and right upper lobe pulmonary vein; or
With thrombus at or near the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the defect is gained unless the individual is protected with other embolic protection devices such as a vena cava filter; or
Whose vasculature, through which access to the defect is gained, is inadequate to accommodate a 10F delivery sheath; or
Whose anatomy would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins should a septal occluder be used; or
With an intra-cardiac mass or vegetation; or
Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin, successfully prior to device placement; or
Whose vasculature is inadequate to accommodate a septal occlusion device.

Devices for transcatheter percutaneous closure of cardiac septal defects must be U.S. Food and Drug Administration (FDA) approved and used according to the labeled indications.

All other devices or uses are considered experimental and investigational E/I and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

93580

93581

93582

All other devices or uses are considered E/I and, therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

93580

Outpatient HCPCS (C Codes)

C1766

C1769

C1817

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes 93580, 93581 and 93582

123.1	123.2	151.0	Q21.0	Q21.1	Q21.2	Q21.3
Q21.9	Q25.0

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