CurrentProvidence Health PlanPolicy 77

Transcatheter Aortic Valve Replacement (TAVR)

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Medical policy governing coverage criteria for transcatheter aortic valve replacement (TAVR) for Providence Health Plan product lines, affecting providers who request authorization for Commercial and Medicaid/OHP members (Medicare applicability limited).

Policy Summary

PayerProvidence Health Plan

PolicyTranscatheter Aortic Valve Replacement (TAVR)

Policy CodePolicy 77

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization and document echocardiographic severity, NYHA class, and heart-team assessment including STS PROM risk score.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2distinct covered indications

NYHA ≥ IIsymptom threshold

≥3%STS PROM threshold (native)

≥8%STS PROM threshold (ViV)

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CurrentProvidence Health PlanPolicy 77

Transcatheter Aortic Valve Replacement (TAVR)

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Policy Summary

PayerProvidence Health Plan

PolicyTranscatheter Aortic Valve Replacement (TAVR)

Policy CodePolicy 77

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization and document echocardiographic severity, NYHA class, and heart-team assessment including STS PROM risk score.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2distinct covered indications

NYHA ≥ IIsymptom threshold

≥3%STS PROM threshold (native)

≥8%STS PROM threshold (ViV)

investigational devices listed

Commercial & Medicaidpolicy applied to

Coverage Criteria for TAVR

TAVR for severe native calcific aortic stenosis

Covered when ALL of the following are met

Native AS medical necessity: A. Documented severe aortic valve stenosis with one or more echocardiography-derived criteria: mean gradient >40 mm Hg OR jet velocity >4.0 m/s OR aortic valve area (AVA) <0.8 cm² OR AVA index <0.5 cm²/m²; B. Symptomatic heart disease due to aortic valve stenosis demonstrated by NYHA Functional Class ≥ II; C. Heart team (including a cardiac surgeon and cardiologist) determines the patient is intermediate surgical risk or greater for open aortic valve replacement (STS PROM ≥ 3% at 30 days).See individual nodes

Procedure must use an FDA‑approved aortic valve and implantation system and be performed via an approach consistent with the device's FDA‑approved labeling.

TAVR for replacement of degenerated bioprosthetic valve (Valve-in-Valve)

Covered when ALL of the following are met

Valve-in-valve medical necessity: A. Documented presence of symptomatic heart disease due to failure (stenosis, insufficiency, or combined) of a surgical bioprosthetic aortic valve; B. Symptomatic heart disease demonstrated by NYHA Functional Class ≥ II; C. Heart team (including a cardiac surgeon and cardiologist) determines the patient is at high surgical risk or greater for open surgery (STS PROM ≥ 8% at 30 days, incorporating other clinical comorbidities).See individual nodes

Procedure must use an FDA‑approved aortic valve and implantation system and be performed via an approach consistent with the device's FDA‑approved labeling.

Coverage by surgical risk and indication

Coverage stance and criteria summarized from device labeling and evidence review

TAVR for native severe aortic stenosis - intermediate or greater surgical risk: TAVR with FDA‑approved devices is indicated when a multidisciplinary Heart Team (including a cardiac surgeon) judges the patient to be at intermediate or greater risk for open surgical therapy (predicted 30‑day surgical mortality ≥ 3% per STS PROM and relevant comorbidities).STS PROM ≥ 3%

Supported by FDA device indications and systematic reviews showing comparable perioperative and 1‑year mortality and improved some clinical outcomes versus SAVR in intermediate‑risk patients.

TAVR for failing surgical bioprosthetic aortic valve (Valve‑in‑Valve): TAVR with FDA‑approved devices is indicated for patients with symptomatic failure of a surgical bioprosthetic aortic valve who are judged by a Heart Team to be at high or greater risk for open surgical therapy (STS operative risk score ≥ 8% or heart‑team judged expected operative mortality ≥ 15%).STS PROM ≥ 8% or expected mortality ≥ 15%

Supported by device labeling, systematic reviews, and guideline statements showing ViV is reasonable in high/prohibitive risk patients.

Valve-in-Valve (ViV) TAVR — Covered when ALL of the following are met

Covered when ALL of the following are met

ViV coverage criteria: A. Patient has bioprosthetic aortic valve dysfunction (stenosis or regurgitation) causing symptomatic heart disease; B. Symptomatic heart disease demonstrated by NYHA Functional Class ≥ II; C. Heart team determines the patient is at high or prohibitive risk for surgical reoperation — STS predicted operative risk ≥ 8% OR heart‑team judged expected mortality for open surgery ≥ 15%; D. Procedure is performed at a Comprehensive Valve Center or specialized center with appropriate multidisciplinary team and surgical backup.STS ≥ 8% OR expected mortality ≥ 15%

Supported by systematic reviews, device labeling, and ACC/AHA and NICE guideline recommendations for ViV in high/prohibitive risk patients.

Contraindications and conditions that render TAVR not medically necessary include, but are not limited to: known hypersensitivity or contraindication to required anticoagulant/antiplatelet regimens; active bacterial endocarditis or other active infections; a non‑calcified aortic valve; severe ventricular dysfunction with left ventricular ejection fraction <20%; congenital unicuspid or bicuspid aortic valve; mixed aortic valve disease with predominant aortic regurgitation (>3+); defined blood dyscrasias (WBC <1000 cells/mm3 or platelets <50,000 cells/mm3, bleeding diathesis or coagulopathy); hypertrophic obstructive cardiomyopathy; intracardiac mass/thrombus/vegetation on echocardiography; acute myocardial infarction within the previous month; transient ischemic attack or stroke within the previous 6 months; or life expectancy <12 months due to non‑cardiac comorbid conditions.

Devices that have not received FDA approval (examples listed in the policy) are considered investigational and are not covered. The policy expressly names the ACURATE TA™ system (Boston Scientific), the Engager TAVI system (Medtronic), and the JenaValve transapical (JenaValve Technology) as not FDA‑approved and therefore not covered. Additionally, valve‑in‑valve (ViV) TAVR is not supported for intermediate‑ or low‑risk surgical patients and is treated separately from FDA‑approved device indications.

Use of Valve‑in‑Valve (ViV) TAVR in patients who are judged to be at intermediate or low surgical risk for reoperation is considered not medically necessary. The evidence summary and systematic reviews did not identify studies supporting ViV‑TAVR in intermediate or low surgical risk populations, and ViV is not approved for these risk groups.

Policy revision notes indicate that on 9/2023 the denial language was updated: indications previously described as 'investigational' were relabeled as 'not medically necessary', clarifying the current coverage stance for those situations.

TAVR for replacement of a degenerated surgical bioprosthetic aortic valve (Valve‑in‑Valve) is considered not medically necessary when the specific coverage criteria for ViV (section III) are not met — for example, when the patient is not symptomatic with NYHA Functional Class ≥ II or when the heart team does not judge the patient to be at high surgical risk (PROM ≥ 8% at 30 days) or greater.

TAVR for native calcific aortic stenosis is considered not medically necessary when the criteria in Section I are not satisfied or when contraindications/precautions are present. Examples include failure to document severe AS by the echocardiographic thresholds (mean gradient >40 mm Hg, jet velocity >4.0 m/s, AVA <0.8 cm², or AVA index <0.5 cm²/m²), absence of symptomatic disease (NYHA < II), or the presence of any listed exclusion such as active infection or inability to tolerate antiplatelet/anticoagulant therapy.

TAVR for native aortic stenosis performed in patients at low surgical risk is considered not medically necessary. The policy cites available systematic reviews and device approval statements to note that current FDA approvals do not support routine TAVR in low‑risk native valve patients, and thus coverage is not indicated for that population. Similarly, Valve‑in‑Valve TAVR is not medically necessary for intermediate‑ or low‑risk patients for surgical reoperation.

The policy explicitly states that ViV‑TAVR for patients at intermediate or low surgical risk (i.e., patients who do not meet high or prohibitive risk criteria) is not covered / not medically necessary. The evidence reviews identified no studies supporting ViV use in intermediate or low risk groups, and guideline statements do not support ViV‑TAVR in these populations.

As part of the 9/2023 annual update, prior policy language that characterized certain uses as 'investigational' was changed to 'not medically necessary'. This relabeling affects previously investigational indications referenced elsewhere in the policy and clarifies that denials for those situations will be issued on the basis of medical necessity.

Coding, Codes, and Key Clinical Thresholds

Codingmixed

No codes listed

FDA Product Codesmixed

NPT	FDA Product Code referenced for aortic valve and implantation systems

Covered CPT Codes (examples and unlisted codes)CPT

33363	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach.
33364	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach.
33365	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach.
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach.
33367	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy).
33370	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support (List separately).
33999	Unlisted procedure, cardiac surgery (used for cerebral embolic protection device placement per document).
93799	Unlisted cardiovascular service or procedure.

inv-17: STS PROM thresholds (eligibility)

Native aortic stenosis PROM thresholdSTS PROM ≥ 3% at 30 days required for intermediate (or greater) surgical risk eligibility for native severe AS

Valve-in-Valve (ViV) PROM thresholdSTS PROM ≥ 8% at 30 days required for high (or greater) surgical risk eligibility for ViV-TAVR

Use of STS PROMPROM is the STS predicted risk of surgical mortality used by the heart team to classify surgical risk for TAVR decisions

inv-18: Echocardiographic severe AS criteria

Mean transvalvular gradientMean gradient > 40 mm Hg defines severe AS by echocardiography

Jet velocity

Provider Requirements, Prior Authorization, and Denial Conditions

Prior Authorization

Prior authorization required for TAVR (Commercial & Medicaid/OHP)

Prior authorization is required for TAVR for Commercial and Medicaid/OHP members; requests must show the procedure uses an FDA‑approved aortic valve and implantation system and is performed via an approach consistent with the device's FDA‑approved labeling.

Applies to Commercial and Medicaid/OHP products per plan product application.
Device must be FDA‑approved and approach consistent with device labeling.

Prior Authorization

Document heart‑team determination and surgical risk

Document the heart‑team determination that the patient’s surgical risk category (e.g., STS PROM) and contraindication screening support the appropriateness of TAVR; the heart team must include a cardiac surgeon and a cardiologist.

Heart team assessment must judge patient to be intermediate risk (PROM ≥3%) for native AS or high risk (PROM ≥8%) for ViV where applicable.
Include evaluation of contraindications listed in policy (e.g., active infection, inability to tolerate anticoagulation).

Background and Scope

Transcatheter aortic valve replacement (TAVR) is a minimally invasive alternative to surgical aortic valve replacement for patients with severe aortic stenosis. Devices are typically delivered percutaneously (commonly transfemoral or transapical approaches), and ViV procedures involve transcatheter implantation of a prosthetic valve within a failed surgical bioprosthetic aortic valve. FDA‑approved device indications and multidisciplinary heart‑team evaluation guide patient selection and coverage determinations.

Definitions and Terms

inv-40: Valve-in-Valve (ViV) — Definition

DefinitionValve‑in‑Valve (ViV) is transcatheter replacement of a degenerated surgical bioprosthetic aortic valve using a transcatheter prosthetic valve

Indication contextTypically considered for patients with bioprosthetic valve failure (stenosis or regurgitation) when surgical reoperation is high or prohibitive risk

Procedure settingPerformed with an FDA‑approved aortic valve and implantation system via an approach consistent with device labeling

inv-41: STS Predicted Risk of Operative Mortality (PROM) — Definition and use

STS PROM definitionSTS Predicted Risk of Operative Mortality (PROM) is the STS cardiac surgery model estimate of 30‑day surgical mortality used to classify operative risk

Role in eligibility

Revision History

2026-07-01annual_reviewLatest

Annual update completed; no changes to clinical coverage criteria.

2024-07annual_review

Annual update completed; no changes to clinical coverage criteria.

2023-09policy_language_change

Policy Summary

PayerProvidence Health Plan

PolicyTranscatheter Aortic Valve Replacement (TAVR)

Policy CodePolicy 77

Change TypeAnnual review — no material changes

Effective DateJul 1, 2026

Last ReviewJul 1, 2026

Next Review DateJun 1, 2027

Key ActionObtain prior authorization and document echocardiographic severity, NYHA class, and heart-team assessment including STS PROM risk score.

SourceLink

On This Page

TAVR in low surgical risk patients: TAVR is considered not medically necessary for patients considered low surgical risk; current FDA approvals and guideline statements do not support routine TAVR in low‑risk native valve patients or ViV in intermediate/low surgical risk reoperation candidates.Low surgical risk = not covered

Supported by FDA approvals, systematic reviews, and guideline guidance indicating insufficient evidence for low‑risk populations.

Peak aortic jet velocity > 4.0 m/s defines severe AS

Aortic valve area (AVA)AVA < 0.8 cm² (echocardiography-derived) indicates severe AS

Indexed AVAAVA index < 0.5 cm²/m² indicates severe AS

inv-19: Symptom threshold — NYHA Functional Class ≥ II

Symptom threshold (NYHA)NYHA Functional Class ≥ II is required to meet symptomatic heart disease criterion for TAVR or ViV-TAVR

Documentation requirementClinical documentation must demonstrate symptoms attributable to aortic valve disease (NYHA ≥ II)

Applies to native and ViV indicationsNYHA ≥ II is specified in criteria for both native severe AS (section I.B) and ViV (section III.B)

inv-20: STS predicted risk of surgical mortality — definitions for intermediate (≥3%) and high (≥8%) examples

Intermediate surgical risk definition (example)STS predicted risk of surgical mortality (PROM) ≥ 3% at 30 days is used to define intermediate (or greater) risk for native AS eligibility

High surgical risk exampleSTS PROM ≥ 8% at 30 days is used to define high (or greater) risk for ViV and some device indications

STS risk model useSTS PROM is the operative mortality estimate incorporated into FDA device indications and heart-team assessment

inv-21: STS predicted operative risk for ViV-TAVR — >= 8%

ViV-TAVR PROM thresholdSTS predicted operative mortality (PROM) ≥ 8% at 30 days is required for Valve‑in‑Valve TAVR eligibility (high risk)

Heart-team assessmentPROM should be determined and documented by the multidisciplinary heart team as part of the eligibility assessment

Supported by evidencePolicy and evidence summary state ViV-TAVR is supported in patients with PROM ≥ 8% or judged to have prohibitive risk

inv-22: Heart-team judged expected mortality risk for open surgery — >= 15%

Heart-team judged expected mortality thresholdHeart-team judged expected mortality for open surgery ≥ 15% can be used to classify high/prohibitive surgical risk

Alternative to STS PROMAn expected mortality ≥ 15% as judged by the heart team is an alternative criterion to STS PROM ≥ 8% for ViV/ high-risk designation

Requires multidisciplinary assessmentThis judgment must be documented by a heart team including an experienced cardiac surgeon and cardiologist

Billing Rule

Prior authorization and coding — unlisted codes recommended

Prior authorization is recommended for unlisted codes and is implied for procedures billed with the listed TAVR CPT codes; coding may affect medical necessity review and is subject to contract, eligibility, and CMS edits.

All unlisted codes are reviewed for medical necessity; prior authorization is recommended to avoid post‑service denial.
Covered CPT examples include 33363–33367 and 33370; unlisted codes such as 33999 or 93799 are reviewed at claim level.

Note

Prior authorization criteria unchanged in 7/2024 and 7/2026

Policy revision history shows annual updates with no changes to criteria in July 2024 and July 2026, indicating prior authorization criteria remained stable across those updates.

Revision entries: 7/2024 — Annual update, no changes to criteria; 7/2026 — Annual update, no changes to criteria.

Step Therapy

No step therapy requirements

There are no step therapy requirements specified in this policy section.

Step Therapy

ViV‑TAVR supported for high/prohibitive surgical risk

Valve‑in‑Valve (ViV) TAVR is supported for patients judged by the heart team to be at high or prohibitive risk for surgical reoperation — defined as STS predicted operative risk ≥ 8% or heart‑team judged expected mortality risk for open surgery ≥ 15%.

Use of ViV‑TAVR is for symptomatic bioprosthetic valve dysfunction when heart team determines patient meets STS ≥8% or expected mortality ≥15%.

Documentation Required

Document echocardiographic measurements of severe AS

Provide echocardiographic measurements that demonstrate severe aortic stenosis: mean gradient, jet velocity, and either AVA or indexed AVA as specified in the policy criteria.

Severe AS criteria include mean gradient >40 mm Hg, jet velocity >4.0 m/s, AVA <0.8 cm², or AVA index <0.5 cm²/m².
Also document NYHA functional class (≥ II) and STS PROM as part of the clinical record.

Documentation Required

Document device FDA approval and adherence to labeling

Document that the device used is FDA‑approved for the indication and that the patient meets the device labeling and contraindication screening (heart‑team assessment and surgical risk per labeling).

Confirm device model is among FDA‑approved aortic valve and implantation systems listed in the policy.
Document contraindication screening (e.g., tolerance of antiplatelet/anticoagulation, active infection).

Documentation Required

Document multidisciplinary heart‑team selection and consent

Document that patient selection and procedural appropriateness were determined by a multidisciplinary heart team including interventional cardiology and cardiothoracic surgery, and that consent discussions reflected alternatives and risks.

Heart team should include interventional cardiologist, cardiac surgeon, cardiac imaging expert, and when appropriate anesthesia and geriatrics.
Consent should include discussion of all treatment options and their advantages/disadvantages.

Note

Include supporting references and guideline alignment in request

When requesting coverage, include citations or rationale showing alignment with cited guidelines and references; document how the case aligns with the applicable guideline recommendations.

Policy references ACC/AHA guidelines, NICE guidance, and multiple systematic reviews and meta-analyses listed in the references.
Document the clinical rationale and guideline alignment in the request to support medical necessity.

Denial Risk

Denial triggers — criteria not met or contraindications present

Requests will be denied when coverage criteria are not met — including failure to meet echocardiographic severity, symptomatic (NYHA ≥ II) threshold, or required surgical risk thresholds — or when listed contraindications are present.

Denials may be issued if echocardiographic criteria (mean gradient, velocity, AVA/index) are not met, patient is asymptomatic (NYHA < II), or STS PROM thresholds are not met.
Presence of contraindications (e.g., active infection, inability to tolerate anticoagulation) can trigger denial.

Denial Risk

Denial risk for non‑FDA‑approved devices (investigational)

Use of devices that are not FDA‑approved (e.g., ACURATE TA, Engager TAVI, JenaValve transapical) is considered investigational and will not be covered; claims for these devices risk denial.

The policy explicitly lists ACURATE TA, Engager TAVI, and JenaValve transapical as not FDA‑approved and not medically necessary.

Denial Risk

Denial risk — ViV‑TAVR for low‑risk patients (not medically necessary)

Valve‑in‑Valve TAVR performed for bioprosthetic valve failure in patients who are at low surgical risk for reoperation is considered not medically necessary and may be denied.

Policy states insufficient evidence to support ViV‑TAVR in low‑risk patients and that use in low/intermediate risk is not supported by guidelines.

Note

Denial language updated (9/2023): 'not medically necessary'

Policy denial language was revised in September 2023 from 'investigational' to 'not medically necessary'; coverage denials should be expected when criteria are not met under the current wording.

Revision note: 9/2023 — Changed denial language from investigational to not medically necessary.

PROM categories (low, intermediate, high, prohibitive) guide TAVR/ViV eligibility and are incorporated into FDA device indications

Calculator availabilityThe STS risk calculator is an online tool available from the Society of Thoracic Surgeons and includes multiple weighted clinical variables

inv-42: Severe AS defined by AVA thresholds — definition

AVA absolute thresholdSevere native calcific aortic stenosis may be defined as aortic valve area ≤ 1.0 cm² (policy notes AVA ≤ 1.0 cm² consistent with device labeling)

Indexed AVA thresholdIndexed AVA (AVA index) ≤ 0.6 cm²/m² is an alternative severity definition cited in device labeling and background

Policy echocardiographic thresholdsPolicy requires AVA < 0.8 cm² or AVA index < 0.5 cm²/m² for native AS criteria specifically, with other standard thresholds referenced in device labeling

inv-43: Contraindication examples — inability to tolerate antiplatelet/anticoagulation, active infection/endocarditis, hypersensitivity

Antiplatelet/anticoagulation intoleranceKnown hypersensitivity or contraindication to anticoagulant/antiplatelet regimens is listed as a contraindication to TAVR

Active infection/endocarditisActive bacterial endocarditis or other active systemic infection is a contraindication to TAVR

Hypersensitivity to implant materials/contrastKnown hypersensitivity to device materials (e.g., nickel, titanium) or contrast media that cannot be premedicated is contraindicated

inv-44: Valve-in-Valve (ViV) TAVR — definition (alternate inventory entry)

Alternate definition of ViVValve‑in‑Valve (ViV) TAVR: transcatheter implantation of a valve within a failed surgical bioprosthetic aortic valve to treat stenosis or regurgitation

Patient selectionTypically used for symptomatic patients with bioprosthetic valve dysfunction who are high or prohibitive surgical risk

Not approved for lower riskUse of ViV‑TAVR in intermediate or low surgical risk patients is not approved and considered not medically necessary

inv-45: Guideline sources — ACC/AHA and NICE guidance referenced

ACC/AHA guidelineAmerican College of Cardiology/American Heart Association guidelines (2020/2017 updates) are referenced as supporting guidance for TAVR and ViV indications

NICE guidanceNational Institute for Health and Care Excellence (NICE) guidance on TAVI and valve‑in‑valve (2017/2019) is cited as an authoritative source

Evidence supportPolicy states guideline recommendations support TAVR for intermediate‑risk native AS and ViV for high‑risk patients

Denial language revised from 'investigational' to 'not medically necessary' for previously investigational indications.

2023-02template_conversion

Policy converted to new policy template.