Transcatheter Aortic Valve Replacement

Policy ID: S-232-012

Section: Surgery

Effective Date: May 01, 2020

Revised Date: December 01, 2021

Revision Effective Date: January 01, 2022

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

Description

Transcatheter aortic valve replacement (TAVR) is a potential alternative treatment for individuals with severe aortic stenosis. Many individuals with aortic stenosis are very elderly and/or have multiple medical comorbidities, indicating high-risk and often prohibitive for surgery. This procedure is being evaluated as an alternative to open surgery for high-risk individuals with aortic stenosis and as an alternative to non-surgical therapy for individuals with a prohibitive risk for surgery.

Criteria

TAVR performed for severe aortic stenosis, using an United States Food and Drug Administration (U.S. FDA)-approved Transcatheter Heart Valve System, may be considered medically necessary when ALL of the following criteria are met:

The individual has aortic stenosis with a calcified aortic annulus, as defined by ONE or MORE of the following criteria:
- An aortic valve area of less than 1.0 cm²; or
- An aortic valve area index of less than or equal to 0.6 cm² /m²; or
- A mean aortic valve gradient greater than 40 mmHg; or
- A peak aortic-jet velocity greater than 4.0 m/sec; and
The individual has New York Heart Association (NYHA) Classification II, III or IV symptoms; and
- Note: See table below
Left ventricular ejection fraction greater than 20%; and
The procedure is being performed by a professional provider and at a facility that meets the recommendations for performing TAVR, as set forth in the Credentialing Recommendations for Heart Valve Replacement Procedure, established in collaboration with the following cardiovascular specialty societies: the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS).

TAVR with a transcatheter heart valve system approved for use for repair of a degenerated bioprosthetic valve may be considered medically necessary when ALL of the following conditions are present:

Failed (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; and
NYHA heart failure class II, III or IV symptoms; and
Left ventricular ejection fraction greater than 20%; and
The individual is not an operable candidate for open surgery, as determined by at least two (2) cardiovascular specialists (cardiologist and/or cardiac surgeon) or individual is at low to high risk for death and complications with open-heart surgery.

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

Procedure Codes

33361

33362

33363

33364

33365

33366

33367

33368

33369

33370

93591

New York Heart Association (NYHA) Classification of Heart Failure

Class I

No limitation of physical activity. Ordinary physical activity does not cause undue breathlessness, fatigue, or palpitations.

Class II

Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue, or palpitations.

Class III

Marked limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue, or palpitations.

Class IV

Unable to carry on any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is undertaken, discomfort is increased.

Diagnosis Codes

Covered Diagnosis Codes for procedure codes 33361, 33362, 33363, 33364, 33365, 33366, 33370, 93591

I06.0

I06.2

I35.0

I35.1

I35.2

I35.8

I35.9

Professional Statements and Societal Positions Guidelines

National Institute For Health And Care Excellence-2019

In June 2019, the National Institute For Health And Care Excellence published interventional procedures guidance [IPG653] regarding valve-in-valve TAVI for aortic bioprosthetic valve dysfunction. The guidance was informed by an Interventional procedure overview described previously. The guidance recommendation is that "Current evidence on the safety and efficacy of valve-in-valve transcatheter aortic valve implantation (ViVâ€‘TAVI) for aortic bioprosthetic dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.”

ND Committee Review

Internal Medical Policy Committee 3-16-2020

Revised policy criteria an aortic valve area of less than 0.8 revised to1.0 cm²;
Added "or" individual is at low to high risk for death and complications with open-heart surgery

Internal Medical Policy Committee 3-17-2021 Revision policy

Removed bullet point

Internal Medical Policy Committee 5-20-2021 Revised policy

Added Professional Statements and Societal Positions;
Added table for New York Heart Association (NYHA) Classification of Heart Failure.

Internal Medical Policy Committee 11-23-2021 Coding update- Effective January 01, 2022

Added procedure code 33370.

Internal Medical Policy Committee 11-29-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-15-2023 Annual Review-no changes in criteria

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-232-011

Section: Surgery

Effective Date: May 01, 2020

Revised Date: May 04, 2021

Revision Effective Date: July 05, 2021

Last Reviewed: May 20, 2020

Archived Date: December 31, 2021

Applies To: Commercial and Medicaid Expansion

Description

Criteria

The individual has aortic stenosis with a calcified aortic annulus, as defined by ONE or MORE of the following criteria:
- An aortic valve area of less than 1.0 cm²; or
- An aortic valve area index of less than or equal to 0.6 cm² /m²; or
- A mean aortic valve gradient greater than 40 mmHg; or
- A peak aortic-jet velocity greater than 4.0 m/sec; and
The individual has New York Heart Association (NYHA) Classification II, III or IV symptoms; and
- Note: See table below
Left ventricular ejection fraction greater than 20%; and
The procedure is being performed by a professional provider and at a facility that meets the recommendations for performing TAVR, as set forth in the Credentialing Recommendations for Heart Valve Replacement Procedure, established in collaboration with the following cardiovascular specialty societies: the American College of Cardiology Foundation (ACCF), the Society for Cardiovascular Angiography and Interventions (SCAI), the American Association for Thoracic Surgery (AATS), and the Society of Thoracic Surgeons (STS).

Failed (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve; and
NYHA heart failure class II, III or IV symptoms; and
Left ventricular ejection fraction greater than 20%; and
The individual is not an operable candidate for open surgery, as determined by at least two (2) cardiovascular specialists (cardiologist and/or cardiac surgeon) or individual is at low to high risk for death and complications with open-heart surgery.

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

Procedure Codes

33361

33362

33363

33364

33365

33366

33367

33368

33369

93591

New York Heart Association (NYHA) Classification of Heart Failure

Class I

No limitation of physical activity. Ordinary physical activity does not cause undue breathlessness, fatigue, or palpitations.

Class II

Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue, or palpitations.

Class III

Marked limitation of physical activity. Comfortable at rest, but less than ordinary physical activity results in undue breathlessness, fatigue, or palpitations.

Class IV

Unable to carry on any physical activity without discomfort. Symptoms at rest can be present. If any physical activity is undertaken, discomfort is increased.

Diagnosis Codes

Covered Diagnosis Codes for procedure codes 33361, 33362, 33363, 33364, 33365, 33366, 93591

I06.0

I06.2

I35.0

I35.1

I35.2

I35.8

I35.9

Professional Statements and Societal Positions Guidelines

National Institute For Health And Care Excellence-2019

ND Committee Review

Internal Medical Policy Committee 3-16-2020 (Revised policy criteria an aortic valve area of less than 0.8 revised to1.0 cm2; Added or individual is at low to high risk for death and complications with open-heart surgery)

Internal Medical Policy Committee 3-17-2021 Revision policy removed bullet point

Internal Medical Policy Committee 5-20-2021 Revised policy added Professional Statements and Societal Positions; added table for New York Heart Association (NYHA) Classification of Heart Failure.

Links

References (PDF)

Disclaimer

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