IV-149-004

Medical Policy:

IV-149-004

Topic:

Transcatheter Aortic Valve Implantation/Replacement (TAVI/TAVR) for Aortic Stenosis

Section:

Surgery

Effective Date:

May 3, 2021

Issued Date:

May 3, 2021

Last Revision Date:

April 2021

Annual Review:

April 2021

This policy version was replaced July 4, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR) is a potential treatment for patients with severe aortic stenosis. Many patients with aortic stenosis are elderly and/or have multiple medical comorbidities, thus indicating a high, often prohibitive, risk for surgery. TAVR is intended as an alternative for patients for whom surgery is prohibitive due to high risk or for patients at risk for open surgery. For patients who are not surgical candidates, medical therapy can partially alleviate the symptoms of aortic stenosis but does not affect the underlying disease progression.

TAVR is performed percutaneously, most often through the transfemoral artery. The artificial valve is passed through the native valve and then expanded and secured. The procedure is performed on the beating heart without cardiopulmonary bypass. A similar procedure can be used to replace a previously implanted but failed or degenerated surgical bioprosthesis. This procedure is often called a “valve-in-valve” approach.

The Food and Drug Administration (FDA) has approved transcatheter aortic valve replacement systems manufactured by Edwards Lifesciences (e.g. SAPIEN®, SAPIEN XT™, SAPIEN 3) Medtronic (e.g. CoreValve™ System, COREVALVE™ Evolut R System and CoreValve Evolut™ PRO System) and Boston Scientific Corporation (LOTUS Edge™).

TAVR procedures are restricted by FDA label to facilities that have specialized heart teams and cardiac surgeons. The implanting physician should be experienced in balloon aortic valvuloplasty and receive specialized training in percutaneous approaches to structural heart disease treatment.

Definitions:

New York Heart Association (NYHA) Classification of Heart Failure:

The NYHA classification consists of 4 categories of heart failure based on a patient’s limitation during physical activity.

Class	Patient Symptoms
I	No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
II	Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).
III	Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.
IV	Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Source: https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure

The Society of Thoracic Surgeons Risk Score is a widely-accepted grading system used to evaluate the risk of mortality and morbidity associated with open-heart surgery based on an analysis of valve operations in the Society of Thoracic Surgeons database. Patient data is entered into the calculator and a percentage is generated indicating risk at 30 days post open-heart surgery. See http://www.sts.org/resources/risk-calculators for more information.

Low risk score: < 3%
Intermediate risk score: ≥ 3 through < 8%
High risk score: ≥ 8%

Porcelain aorta (severely calcified ascending aorta) and hostile chest (i.e. chest conditions that make operation through a sternotomy or thoracotomy prohibitively hazardous) are absolute contraindications to open surgical valve replacement (SAVR).

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

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

I. Native Valve Replacement

Transcatheter aortic valve replacement (TAVR) may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients with native valve aortic stenosis when ALL of the following criteria are met:

Use of FDA-approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA-approved labeling; AND
Severe aortic stenosis with a calcified aortic annulus as defined by one or more of the following criteria:
- Aortic valve area of less than or equal to 1 cm²; or
- Aortic valve area index of less than or equal to 0.6 cm²/m²; or
- Mean aortic valve gradient greater than or equal to 40 mm Hg; or
- Peak aortic-jet velocity greater than or equal to 4.0 m/s; AND
New York Heart Association (NYHA) heart failure Class II, III or IV symptoms; AND
Left ventricular ejection fraction >20%; AND
EITHER of the following:
- Patient is not an operable candidate for open surgery, as judged by at least two cardiovascular specialists (cardiologist and cardiac surgeon/interventional cardiologist), AND ONE of the following:
  1. Predicted risk of operative mortality; or
  2. Risk of serious irreversible morbidity 50% or higher for open surgery; OR
- Patient is an operable candidate at intermediate risk or higher for open surgery, as judged by at least two cardiovascular specialists (cardiologist and cardiac surgeon), AND ONE of the following:
  1. STS Risk Score (surgical mortality) ≥ 3% at 30 days; or
  2. An anatomical chest condition that make operation through a sternotomy or thoracotomy prohibitively hazardous (e.g. porcelain aorta, hostile chest) in an otherwise low-risk patient; AND
NONE of the following comorbid conditions or contraindications that would preclude the expected benefit from aortic stenosis correction:
- Intolerance or contraindication to anticoagulation/antiplatelet regimen; OR
- Hypertrophic cardiomyopathy; OR
- Severe (greater than 3+) mitral regurgitation; OR
- Severe (greater than 3+) aortic regurgitation; OR
- Minimal survival benefits due to non-cardiac co-morbid conditions; AND
TAVR is performed by a cardiac surgeon/interventional cardiologist experienced in performing percutaneous approaches to structural heart disease.

II. Failed Surgical Bioprosthetic Valve (Valve-in-Valve)

Transcatheter aortic valve replacement (TAVR) may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients with a failed or degenerated bioprosthetic valve when ALL of the following criteria are met:

Use of FDA-approved transcatheter heart valve system approved for use in repair of a degenerated bioprosthetic valve; AND
Failed (stenosed, insufficient, or combined) surgical bioprosthetic aortic valve; AND
New York Heart Association (NYHA) heart failure Class II, III or IV symptoms; AND
Left ventricular ejection fraction >20%; AND
Patient is not an operable candidate for open surgery, as judged by at least two cardiovascular specialists (cardiologist and cardiac surgeon) AND ONE of the following:
- Predicted risk of operative mortality; or
- Risk of serious irreversible morbidity 50% or higher for open surgery; OR
Patient is an operable candidate but is at high risk for open surgery, as judged by at least two cardiovascular specialists (cardiologist and cardiac surgeon) as indicated by ONE of the following:
- STS Risk Score (surgical mortality) > 8% at 30 days; OR
- At 15% or greater surgical mortality risk for open surgery.
TAVR is performed by a cardiac surgeon experienced in performing percutaneous approaches to structural heart disease.

III. Transcatheter aortic valve replacement is considered EXPERIMENTAL/INVESTIGATIVE for all other indications due to lack of clinical evidence demonstrating an impact on improved health outcomes.

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Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:

Clinical notes describing the following:

For native valve replacement:
1. Specific valve to be used and approach planned (e.g. transfemoral); AND
2. Aortic stenosis severity measurement; AND
3. New York Heart Association (NYHA) heart failure classification; AND
4. Left ventricular ejection fraction measurement; AND
5. If not an operable candidate, documentation from two cardiovascular specialists making this determination and EITHER:
  1. Predicted risk of operative risk of mortality risk; OR
  2. Percent risk of serious irreversible morbidity for open heart surgery; OR
6. If operable candidate, documentation from two cardiovascular specialists making this determination and EITHER:
  1. STS Risk Score (Mortality) score; OR
  2. Any anatomical consideration requiring a transcatheter approach (e.g. porcelain aorta)
7. Attestation from cardiac surgeon describing personal experience in performing percutaneous approaches to structural heart disease management.

For failed surgical bioprosthetic valve (Valve-in-Valve):
1. Documentation 1 – 4 above; AND
2. Failure of surgical bioprosthetic aortic valve; AND
3. If not an operable candidate, documentation from two cardiovascular specialists making this determination and EITHER:
  1. Predicted risk of operative risk of mortality risk; OR
  2. Percent risk of serious irreversible morbidity for open heart surgery; OR
4. If operable candidate, documentation from two cardiovascular specialists making this determination and EITHER:
  1. STS Risk Score (Mortality); OR
  2. Percent risk of surgical mortality for open surgery; AND
5. Attestation from cardiac surgeon describing personal experience in performing percutaneous approaches to structural heart disease management.

Link to Pre-Authorization Form: https://www.bluecrossmn.com/sites/default/files/DAM/2021-12/BCBSMN-Pre-Auth-Request-fillable-X18509R07.pdf

Denial Statements

No additional statements.

Links

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