ModifiedKaiser PermanentePolicy N/A

Transcatheter Aortic or Pulmonary Valve Replacement (TAVR/TPVI)

Clinical review criteria governing medical necessity determinations for transcatheter aortic valve replacement (TAVR), valve-in-valve TAVR (VI-TAVI/TAV-in-SAV), and transcatheter pulmonary valve implantation (TPVI) for Kaiser Foundation Health Plan of Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyTranscatheter Aortic or Pulmonary Valve Replacement (TAVR/TPVI)

Policy CodePolicy N/A

Change TypeMaterial clinical updates and criteria revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of FDA-approved device use, indicated diagnosis, and heart team participation meeting program qualifications.

SourceLink

POLICY UPDATE CHANGES

Policy language was updated to endorse coverage of TAVR for low-surgical risk patients based on recent pivotal trial evidence (PARTNER 3 and Evolut Low Risk).

Valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) was added as an assessed indication following MTAC review.

Applicable ejection fraction criterion for TPVI was changed from >15% to >20%.

2Pivotal RCTs cited

≥50Min open heart surgeries/year

≥20Min aortic valve procedures (2 yrs)

Required

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STS/ACC TVT Registry

≥35 mm HgTPVI RVOT gradient

33361-33369TAVR CPT codes listed

Coverage Criteria for TAVR, Valve-in-Valve, and TPVI

Transcatheter Aortic Valve Replacement (TAVR)

Covered when ALL of the following are met

TAVR general criteria: 1) Use of an FDA approved device; 2) Documentation of severe, symptomatic aortic valve stenosis; 3) The patient (preoperatively and postoperatively) is under the care of a heart team (a cohesive, multidisciplinary team) in which the cardiac surgeon and interventional cardiologist have independently examined the patient and documented suitability for SAVR, TAVR, or medical therapy; 4) The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra-operative technical aspects of TAVR; 5) TAVR must be furnished in a hospital with appropriate infrastructure and meet specified volume and qualification requirements (see program qualifications for hospitals and heart teams).

Hospital and heart team qualifications differ for programs with and without prior TAVR experience; participation in the STS/ACC TVT Registry is required for experienced programs.

Valve-in-Valve Transcatheter Aortic Valve Implantation

Covered when ALL of the following are met

Valve-in-Valve (VI-TAVI / TAV-in-SAV): 1) Use of an FDA approved device; 2) The patient (preoperatively and postoperatively) is under the care of a multidisciplinary heart team; 3) Documentation of a failed aortic tissue prosthesis resulting in symptomatic stenosis or regurgitation; 4) Patient is judged by the heart team to be an appropriate candidate for valve-in-valve TAVR (typically high or extreme surgical risk when redo surgery is applicable).

FDA has expanded approvals for certain systems (eg, SAPIEN XT, CoreValve) for valve-in-valve use in patients at high or extreme surgical risk; outcomes evidence is primarily observational and long-term durability is uncertain.

Transcatheter Pulmonary Valve Implantation (TPVI)

Covered when ANY of the following congenital RVOT indications are met

TPVI indications: - Right ventricle-to-pulmonary artery conduit (with or without bioprosthetic valve) with at least moderate pulmonic regurgitation; OR - Native or patched RVOT with at least moderate pulmonic regurgitation; OR - Right ventricle-to-pulmonary artery conduit (with or without bioprosthetic valve) with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); OR - Native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg)mean RVOT gradient >=35 mm Hg for stenosis indications

All other TPVI indications are not covered due to insufficient evidence.

Covered with clinical criteria

Coverage conclusions from MTAC and evidence reviews:

Valve-in-Valve (VIV-TAVI): VIV-TAVI is feasible and relatively safe based on observational studies and registries, but there is insufficient direct evidence to determine equivalence or superiority to redo surgical replacement and insufficient long-term durability data.

Use meets Kaiser Permanente Medical Technology Assessment Criteria when patient selection and heart team judgment support use.

TAVR for low-surgical risk aortic stenosis: TAVR meets MTAC criteria for use in low-surgical risk patients based on pivotal trials (PARTNER 3 and Evolut Low Risk) showing non-inferiority; PARTNER 3 showed superiority for a 1-year composite endpoint but not for individual components.

Trials demonstrate lower rates of AKI, new atrial fibrillation, and bleeding but higher risk of permanent pacemaker implantation and paravalvular leak; long-term durability remains uncertain.

Coverage for transcatheter aortic valve replacement (TAVR), valve‑in‑valve TAVR (VIV‑TAVI/TAV‑in‑SAV), and transcatheter pulmonary valve implantation (TPVI) is limited to the specific clinical indications and program qualifications described in this policy. All other indications not explicitly listed are not covered because there is insufficient evidence to support effectiveness.

Valve‑in‑valve transcatheter aortic valve implantation (VIV‑TAVI) has observational and registry evidence supporting feasibility and relative safety, but there are insufficient data demonstrating equivalence or superiority to redo conventional surgical valve replacement. Additionally, published evidence is inadequate to determine the long‑term efficacy and durability of valve‑in‑valve implants; these evidence gaps may limit coverage when surgical reoperation is the preferred option.

Procedures performed outside the stated indications or at facilities that do not meet the required infrastructure, volume, and credentialing thresholds are not supported. The policy requires hospitals and programs to meet specified program qualifications (for example, annual AVR/TAVR procedural volumes, cardiac surgery and interventional cardiology privileges, PCI volume, and participation in the STS/ACC TVT Registry) for services to be considered covered; procedures done outside these program and heart team requirements are not covered.

The available literature for VIV‑TAVI consists mainly of observational studies, single‑center case series, and registries from multiple countries. No randomized controlled trials directly comparing valve‑in‑valve implantation to redo surgical replacement have been published, and systematic reviews/meta‑analyses rely on nonrandomized data. Because of the observational nature of the evidence and limited long‑term follow‑up, the policy concludes there is insufficient direct evidence to establish equivalence or superiority to redo surgery and insufficient published data on long‑term durability of valve‑in‑valve procedures.

Codes, Volumes, and Procedural Thresholds

Transcatheter aortic valve replacement (TAVR/TAVI) CPT codesCPTCovered

33361	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach.
33362	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach.
33363	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach.
33364	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach.
33365	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy).
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy).
33367	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (eg, femoral vessels) (List separately in addition to code for primary procedure).
33368	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure).
33369	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure).

Transcatheter pulmonary valve implantation (TPVI) CPT codesCPTCovered

33477

Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed.

Mean RVOT gradient threshold for pulmonic stenosis indication (clinical threshold)

Mean RVOT gradient threshold>= 35 mm Hg

Indication contextApplies to pulmonic stenosis indications for TPVI (conduit or native/patched RVOT)

Coverage noteAll other TPVI indications not meeting this threshold are not covered due to insufficient evidence

Hospital procedural volume to maintain experienced TAVR program — volume requirements

Experienced program volume (annual)>= 50 AVRs (TAVR or SAVR) per year including >= 20 TAVR procedures in the prior year

Experienced program volume (biennial alternative)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for TAVR and TPVI procedures. Verify authorization requirements for the specific CPT/HCPCS code and plan type using the Pre-authorization Code Check prior to scheduling.

Prior authorization required for TAVR/TPVI CPT codes (e.g., 33361–33369, 33477).
Use the Pre-authorization Code Check to confirm requirements by plan and to ensure codes are current.

Documentation Required

Medical Necessity and Heart Team Participation

Medical necessity for TAVR, valve‑in‑valve TAVR, and TPVI must meet the documented criteria and the patient must be managed by a multidisciplinary heart team. The heart team must include, at minimum, an interventional cardiologist and a cardiac surgeon who have independently examined the patient, evaluated suitability for SAVR versus TAVR versus medical/palliative care, and documented their clinical rationale for the chosen approach. Requests that do not meet medical necessity criteria or lack heart team documentation may be denied.

Clinical Background

Aortic stenosis is common in older adults and, when symptomatic, carries high morbidity and mortality. Surgical aortic valve replacement (SAVR) remains the standard treatment for many patients; however, a substantial proportion of patients are at high or prohibitive surgical risk and may be candidates for transcatheter approaches. Transcatheter aortic valve replacement (TAVR) provides a less invasive alternative and, based on pivotal randomized trials (PARTNER 3 and Evolut Low Risk), has been adopted for selected low‑surgical‑risk patients as well as for higher‑risk patients. TAVR and valve‑in‑valve procedures have specific procedure‑related risks (including stroke, vascular injury, conduction disturbances leading to pacemaker implantation, and paravalvular leak) and require careful selection and management by a multidisciplinary heart team in a program that meets the stated infrastructure and volume qualifications.

Key Definitions

Heart team — multidisciplinary team definition

Minimum core membersAt minimum, a cardiac surgeon and an interventional cardiologist who independently examine the patient and document suitability

Multidisciplinary roleCohesive team that jointly participates in intra-operative technical aspects and manages pre/postoperative care

Documentation requirementHeart team must document rationale for recommending SAVR, TAVR, or medical therapy

Valve-in-valve (VIV-TAVI / TAV-in-SAV) — definition of transcatheter valve within failed surgical bioprosthesis

DefinitionTranscatheter implantation of a valve within a failed surgical bioprosthetic aortic valve as an alternative to redo surgical valve replacement

Indication contextConsidered for patients with failed bioprosthetic tissue valves causing symptomatic stenosis or regurgitation

Policy Revision History

06/18/2012MTAC review

MTAC reviewed valve-in-valve (VIV‑TAVI) evidence noting observational studies and registries; findings informed subsequent policy assessments.

05/05/2015Policy revision

TPVI ejection fraction requirement changed from >15% to >20%.

08/02/2016Policy history update

MTAC review for Valve‑in‑Valve Transcatheter Aortic Valve Implantation added to policy history.

Policy Summary

PayerKaiser Permanente

PolicyTranscatheter Aortic or Pulmonary Valve Replacement (TAVR/TPVI)

Policy CodePolicy N/A

Change TypeMaterial clinical updates and criteria revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of FDA-approved device use, indicated diagnosis, and heart team participation meeting program qualifications.

SourceLink

On This Page

>= 100 AVRs every 2 years including >= 40 TAVR procedures in the prior 2 years

Registry participationParticipation in the STS/ACC TVT Registry is required

Minimum open heart surgeries to begin TAVR program (hospital without prior TAVR experience)

Minimum open heart surgeries (hospital without prior TAVR)>= 50 open heart surgeries in the previous year

Other facility prerequisitesOn-site heart valve surgery and interventional cardiology programs; post-procedure ICU experienced with valve patients

Team personnel requirements>= 2 physicians with cardiac surgery privileges and >= 1 physician with interventional cardiology privileges

Minimum aortic valve-related procedures to begin TAVR program

Aortic valve-related procedures requirement>= 20 aortic valve-related procedures in the 2 years prior to TAVR program initiation

Surgeon experience requirementCardiovascular surgeon on team should have >= 100 career open heart surgeries with >= 25 aortic valve-related

Device trainingInterventional cardiologist must have device-specific training as required by the manufacturer

PCI volume requirement for program qualifications

PCI volume requirement>= 300 percutaneous coronary interventions (PCIs) per year

Applies toRequired for hospitals initiating a TAVR program and for maintaining experienced TAVR programs

Consistent staffing implicationReflects need for ongoing interventional cardiology procedural capacity

TPVI ejection fraction criterion (changed from >15% to >20%)

TPVI left ventricular ejection fraction criterion>20% (criterion revised from >15% to >20%)

Change historyEjection fraction change documented 05/05/2015; noted in policy history

ApplicationApplied to TPVI candidate selection per policy updates

TAVR: FDA‑approved device; severe symptomatic aortic stenosis; heart team participation with documented independent evaluations and rationale.
Valve‑in‑Valve TAVR: FDA‑approved device; failed bioprosthetic valve causing symptomatic stenosis or regurgitation; heart team participation.
TPVI: Indications limited to congenital heart disease with RVOT obstruction or regurgitation as specified in policy.

Denial Risk

Coverage Limited to Specified Indications and Qualified Programs

Coverage is limited to the specific indications and to procedures performed at qualified programs that meet volume and staffing requirements. Requests outside the stated indications or from programs that do not meet the listed qualifications are not covered.

Kaiser Foundation Health Plan of Washington program qualifications: ≥50 AVRs/year (including ≥20 TAVR in prior year) OR ≥100 AVRs every 2 years (including ≥40 TAVR in prior 2 years); ≥2 physicians with cardiac surgery privileges; ≥1 physician with interventional cardiology privileges; ≥300 PCIs/year; participation in the STS/ACC TVT Registry.
TPVI and other indications are covered only as listed; all other indications are not covered due to insufficient evidence.

Documentation Required

Required Clinical Documentation

Providers must submit documentation to support medical necessity and authorization. Include recent clinical information, objective testing, and heart team documentation.

Last 6 months of clinical notes from the requesting provider and/or specialist.
Documentation of symptomatology, imaging and hemodynamic data supporting severity (e.g., echocardiography gradients, valve area, RVOT gradients for TPVI).
Heart team notes: independent examinations by cardiac surgeon and interventional cardiologist and the documented rationale for treatment choice.

Billing Rule

Authorization and Coding Verification

Verify coding and authorization at time of service. Codes deleted or not in effect at the time of service may not be covered. Confirm CPT/HCPCS descriptions and any plan-specific billing rules before submission.

Common TAVR CPT codes: 33361–33369 (see policy for full descriptions).
TPVI CPT code: 33477.
Deleted codes or codes not in effect at time of service may not be covered; verify current code status.
Use AMA/CMS code descriptions and the Pre-authorization Code Check to confirm coding and authorization requirements.

Note

Role of Surgical Reoperation vs Valve‑in‑Valve

Surgical reoperation (redo SAVR) remains the standard of care for many patients with failed bioprosthetic valves; valve‑in‑valve TAVR is an alternative primarily for patients at high or prohibitive surgical risk. Documentation should explain why reoperation is not appropriate when valve‑in‑valve is requested.

When valve‑in‑valve TAVR is requested, include documentation of surgical risk assessment and reasons reoperation is not suitable (comorbidities, frailty, prior chest radiation, prior sternotomy risks).
If the patient is a surgical candidate and reoperation is appropriate, SAVR may be preferred and requests for valve‑in‑valve should justify deviation from standard surgical care.

Documentation Required

Documentation and Code Verification

Submit supporting documentation with the authorization request and retain copies for claims. Incomplete documentation or missing heart team notes increases the risk of denial.

Attach clinical notes, imaging reports, catheterization/hemodynamic data, operative history, and heart team consensus documentation to the authorization request.
Verify that the CPT/HCPCS codes submitted match the documented procedure and are valid on the date of service.

Evidence summaryOutcomes primarily from observational studies and registries; long-term durability uncertain

VIV-TAVI — Valve-in-valve transcatheter aortic valve replacement definition

DefinitionValve-in-valve transcatheter aortic valve replacement — transcatheter implantation of a new valve within a failed surgical bioprosthetic valve

Comparative evidenceNo randomized trials directly comparing VIV-TAVI to surgical reoperation; evidence from registries and observational studies

Patient selectionOften considered for patients at high or extreme surgical risk for redo surgery

TAVR/TAVI — Transcatheter aortic valve replacement/implantation definition

DefinitionTranscatheter aortic valve replacement/implantation (TAVR/TAVI): percutaneous or alternative transcatheter approaches to replace the aortic valve without conventional open surgery

Evidence for low-risk usePivotal RCTs (PARTNER 3, Evolut Low Risk) showed non-inferiority in low-surgical risk patients; PARTNER 3 suggested 1-year composite superiority

Procedural considerationsRequires heart team participation and hospital infrastructure meeting volume and qualification requirements

09/06/2016Policy adoption

New policy for Valve‑in‑Valve implantation was adopted.

12/03/2019MPC action

MPC approved adoption of updated Medicare indication requiring one cardiologist and one interventional cardiologist for commercial members; KPWA retained high‑risk restriction.

01/13/2020MTAC review (evidence conclusion)

MTAC concluded pivotal trials (PARTNER 3, Evolut Low Risk) support TAVR in low‑surgical‑risk patients and summarized uncertainties about long‑term durability and generalized applicability.

03/03/2020MPC approval

MPC approved endorsement of coverage policy for TAVR for low‑surgical‑risk patients and added January 2020 MTAC review to the policy.

05/05/2020MPC update

MPC approved updates to clinical indications for non‑Medicare members (60‑day notice; effective 2020‑09‑01).

06/01/2021Administrative updateLatest

Policy retitled to include TPVI.