Transcatheter Closure Devices for Septal Defects

Policy ID: S-152-028

Section: Surgery

Effective Date: November 01, 2019

Revised Date: October 18, 2023

Revision Effective Date: January 01, 2024

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

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

The United States Food and Drug Administration (U.S. FDA) approved percutaneous septal occlusion device used according to labeling, may be considered medically necessary for ANY of the 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; or
Whose vasculature is inadequate to accommodate a septal occlusion device.

All other devices or uses not meeting the criteria as indicated in this policy is 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

93581

93582

93662

Transcatheter closure of patent foramen ovale (PFO) with U.S. 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.

Procedure Code

93580

Outpatient HCPCS (C Codes)

C1766

C1769

C1817

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes: 93580, 93581, 93582,and 93662

I23.1

I23.2

I51.0

Q21.0

Q21.10

Q21.11

Q21.12

Q21.13

Q21.14

Q21.15

Q21.16

Q21.19

Q21.20

Q21.21

Q21.22

Q21.23

Q21.3

Q21.9

Q25.0

Professional Statements and Societal Positions Guidelines

American College of Cardiology and American Heart Association-2018

The American College of Cardiology and American Heart Association updated guidelines on the management of adults with congenital heart disease. The treatment recommendations are summarized in the table below, coronary sinus, or primum atrial septal defect, however, surgery rather than percutaneous closure was recommended.

Table:

Condition

Recommendation

COR ^a /LOE ^b

Symptomatic isolated secundum ASD, right atrial and/or RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise

Transcatheter or surgical closure

I1/B-NR2

Symptomatic primum ASD, sinus venosus defect, or coronary sinus defect, right atrial and/or RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise

Surgical closure unless precluded by comorbidities

I1/B-NR2

Asymptomatic isolated secundum ASD, right atrial and RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise

Transcatheter or surgical closure

IIa1/C-LD2

Secundum ASD when a concomitant surgical procedure is being performed and there is a net left-to-right shunt sufficiently large enough to cause physiological sequelae, and right atrial and RV enlargement without cyanosis at rest or during exercise

Surgical closure

IIa1/C-LD2

ASD when net left-to-right shunt is greater than or equal to 1.5:1, PA systolic pressure and/or pulmonary vascular resistance is greater than of one-third of systemic resistance

Percutaneous or surgical closure

IIb1/B-NR2

ASD with PA systolic pressure greater than two-thirds systemic, pulmonary vascular resistance greater than two-thirds systemic, and/or a net left-to-right shunt

ASD closure should not be performed

III-Harm1/C-LD2

ND Committee Review

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

Internal Medical Policy Committee 9-21-2020 policy revision

Internal Medical Policy Committee 9-21-2021 Annual Review

No changes in criteria,
Updated language

Internal Medical Policy Committee 01-20-2022 Revision

Added American College of Cardiology and American Heart Association-2018 information to Professional Statements and Societal Positions, and
Added updated clarifying language throughout policy.

Internal Medical Policy Committee 9-20-2022 Coding update - Effective October 01, 2022

Removed Diagnosis codes Q21.1; Q21.2
Added Diagnosis codes Q21.10; Q21.11; Q21.12; Q21.13; Q21.14; Q21.15; Q21.16; Q21.19; Q21.20; Q21.21; Q21.22; Q21.23

Internal Medical Policy Committee 9-12-2023 Annual Review - no changes in criteria

Internal Medical Policy Committee 11-15-2023 Coding update - Effective January 01, 2023

Added Procedure code 93662.
Updated References.

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-152-027

Section: Surgery

Effective Date: November 01, 2019

Revised Date: September 20, 2022

Revision Effective Date: October 01, 2022

Last Reviewed: September 12, 2023

Archived Date: December 31, 2023

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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; or
Whose vasculature is inadequate to accommodate a septal occlusion device.

Procedure Codes

93580

93581

93582

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

American College of Cardiology and American Heart Association-2018

Table:

Condition

Recommendation

COR^a/LOE^b

Transcatheter or surgical closure

I1/B-NR2

Surgical closure unless precluded by comorbidities

I1/B-NR2

Asymptomatic isolated secundum ASD, right atrial and RV enlargement, and net left-to-right shunt sufficiency large enough to cause physiological sequelae, without cyanosis at rest or during exercise

Transcatheter or surgical closure

IIa1/C-LD2

Surgical closure

IIa1/C-LD2

ASD when net left-to-right shunt is greater than or equal to 1.5:1, PA systolic pressure and/or pulmonary vascular resistance is greater than of one-third of systemic resistance

Percutaneous or surgical closure

IIb1/B-NR2

ASD with PA systolic pressure greater than two-thirds systemic, pulmonary vascular resistance greater than two-thirds systemic, and/or a net left-to-right shunt

ASD closure should not be performed

III-Harm1/C-LD2

ND Committee Review

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

Internal Medical Policy Committee 9-21-2020 policy revision

Internal Medical Policy Committee 9-21-2021 Annual Review

No changes in criteria,
Updated language

Internal Medical Policy Committee 01-20-2022 Revision

Added American College of Cardiology and American Heart Association-2018 information to Professional Statements and Societal Positions, and
Added updated clarifying language throughout policy.

Internal Medical Policy Committee 9-20-2022 Coding update - Effective October 01, 2022

Removed Diagnosis codes Q21.1; Q21.2
Added Diagnosis codes Q21.10; Q21.11; Q21.12; Q21.13; Q21.14; Q21.15; Q21.16; Q21.19; Q21.20; Q21.21; Q21.22; Q21.23

Internal Medical Policy Committee 9-12-2023 Annual Review - no changes in criteria

Links

References (PDF)

Disclaimer

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