Description

Transcatheter aortic valve implantation (TAVI) 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.

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.

Criteria

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

TAVR performed via the transfemoral or transapical approach, for severe aortic stenosis, using a Food and Drug Administration (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 0.8 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:

I. No symptoms and no limitation in ordinary physical activity, (e.g., shortness of breath when walking, climbing stairs etc.).

II. Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

III. Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g., walking short distances (20-100m). Comfortable only at rest.

IV. Severe limitations. Experiences symptoms even while at rest. Mostly bed bound individuals; 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 an operable candidate but is at intermediate risk or high risk for open surgery; 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 cardiacsurgeon) or individual is an operable candidate but is at immediate risk or high risk for open surgery.

TAVR is considered not medically necessary when performed for indications other than those listed in the above criteria.

Procedure Codes

Diagnosis Codes

Covered Diagnosis Codes for procedure codes 33361, 33362, 33366, 93591