CurrentPremera BluecrossPolicy 7.01.132

Transcatheter Aortic-Valve Implantation for Aortic Stenosis

Defines medical necessity criteria, documentation and coding guidance, investigational indications (including cerebral embolic protection devices), and related definitions for transcatheter aortic valve replacement (including valve-in-valve) in individuals with native or bioprosthetic aortic valve disease.

Policy Summary

PayerPremera Bluecross

PolicyTranscatheter Aortic-Valve Implantation for Aortic Stenosis

Policy CodePolicy 7.01.132

Change TypeMultiple: administrative, clarifications, additions, coding update

Effective Date

Next Review Date

Key ActionDocument diagnosis, severity, NYHA class, operability/high surgical risk and that an FDA‑approved transcatheter heart valve system will be used consistent with labeling; for ViV and special-risk cases obtain documentation from at least 2 cardiovascular specialists including a cardiac surgeon.

SourceLink

POLICY UPDATE CHANGES

Policy replaced prior policy 7.01.585; header shows Replaces: Aug. 1, 2025 and Last Revised Apr. 1, 2026.

For TAVI and ViV TAVI, the criterion of left ventricular ejection fraction greater than 20% was removed.

Statement added for consideration of individuals at increased surgical risk not demonstrated on STS score; requires documentation by at least 2 cardiovascular specialists including a cardiac surgeon.

Use of a cerebral embolic protection device during TAVR is considered investigational.

HCPCS code C8010 added effective April 1, 2026.

2Primary covered scenarios (native valve, valve-in-valve)

1Investigational indication (cerebral embolic protection)

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6Key CPT/HCPCS codes listed

MedicareCMS coverage with conditions

multipleRevision history entries

Coverage Summary

Scope: This policy addresses transcatheter aortic valve implantation/replacement (TAVR/TAVI) for treatment of severe aortic stenosis in native valves and for valve‑in‑valve (ViV) implantation to repair degenerated surgical bioprosthetic aortic valves, defines medical necessity criteria and documentation/coding requirements, and states that use of cerebral embolic protection devices during TAVR is investigational. The policy applies to FDA‑approved transcatheter heart valve systems used consistent with device labeling and includes guidance on heart‑team evaluation, registry participation, and required specialist documentation for increased surgical risk. Status: CURRENT.

Key Clinical Thresholds

Aortic valve area (severe AS)≤ 1.0 cm^2

Indexed aortic valve area (severe AS)≤ 0.6 cm^2/m^2

Mean aortic valve gradient (severe AS)>= 40 mm Hg

Peak aortic-jet velocity (severe AS)>= 4.0 m/s

STS predicted operative risk — high>= 8%

STS predicted operative risk — intermediate3% to 7%

FDA extreme/inoperable risk definitionPredicted operative mortality and/or serious irreversible morbidity >= 50%

NYHA class required for coverageClass II, III, or IV symptoms

Predicted post-procedure survival for recommending TAVI> 12 months

Increase in aortic velocity prompting AVR consideration>= 0.3 m/s per year

LVEF threshold on serial imaging for consideration< 60% on ≥ 3 serial studies

B-type natriuretic peptide threshold> 3 times normal

Sentinel cerebral protection artery diametersBrachiocephalic 9–15 mm; left common carotid 6.5–10 mm

Medical Necessity Criteria

TAVR/TAVI for native valve aortic stenosis - Medical Necessity

Covered when ALL of the following are present:

ALL of the following

Severe aortic stenosis with a calcified aortic valve (see Definition of Terms)
New York Heart Association (NYHA) heart failure class II, III, or IV symptoms
Individual does not have unicuspid or bicuspid aortic valves
Procedure uses an FDA-approved transcatheter heart valve system and is performed via an approach consistent with the device's FDA-approved labeling
Implied – must be documented

ALL of the following

Investigational / Not Medically Necessary

Not covered / investigational when criteria below apply:

Transcatheter aortic valve replacement for all other indications when above criteria are not met

Use of a cerebral embolic protection device (e.g., Sentinel) during TAVR is considered investigational

Investigational / Not Covered

Use of a cerebral embolic protection device during TAVR is considered investigational.

Historically investigational statements applied for treatment of degenerated bioprosthetic valve or failed TAVI (Valve-in-Valve approach) were previously investigational but later changed to medically necessary for high/prohibitive risk; interpret current policy that ViV TAVI is medically necessary in high/prohibitive risk.

Coding

Covered CPT codes for TAVR/TAVI primary proceduresCPTCovered

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 (e.g., median sternotomy, mediastinotomy)
33366	Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (e.g., left thoracotomy)

Covered CPT codes for cardiopulmonary bypass support (add-on)CPTCovered

33367	Cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (e.g., femoral vessels) — add-on to primary TAVR/TAVI procedure
33368	Cardiopulmonary bypass support with open peripheral arterial and venous cannulation (e.g., femoral, iliac, axillary vessels) — add-on to primary TAVR/TAVI procedure
33369	Cardiopulmonary bypass support with central arterial and venous cannulation (e.g., aorta, right atrium, pulmonary artery) — add-on to primary TAVR/TAVI procedure

CPT code for cerebral embolic protection placement/removalCPT

33370

Transcatheter placement and subsequent removal of cerebral embolic protection device(s), including arterial access, catheterization, imaging, and radiological supervision and interpretation — list separately in addition to code for primary procedure

HCPCS codes related to embolic protection devicesHCPCS

C1884	Embolization protective system
C8010	Percutaneous placement of permanent common carotid embolic protection device, including all system components and imaging guidance; bilateral (new code effective April 1, 2026)

FDA-cleared transcatheter aortic valve systemsmixed

Edwards SAPIEN XT (model 9300TFX)	Balloon-expandable transcatheter heart valve system (Edwards) — included/reference to SAPIEN XT model 9300TFX
SAPIEN 3 THV System / SAPIEN 3 Ultra	Latest generation balloon-expandable transcatheter heart valve systems (Edwards) — SAPIEN 3 and SAPIEN 3 Ultra
Boston Scientific / Claret Sentinel Cerebral Protection System	Cerebral embolic protection device cleared for use to capture and remove embolic debris during TAVR/TAVI procedures

Cerebral embolic protection device regulatory statusmixed

Sentinel Cerebral Protection System (Boston Scientific / Claret)

Device referenced in policy; noted as cerebral embolic protection system — policy considers use investigational for TAVR/TAVI

Added/Updated CPT and HCPCS codes referenced in historymixed

C8010

Percutaneous placement of permanent common carotid embolic protection device, including all system components and imaging guidance; bilateral — new HCPCS code effective April 1, 2026

Provider Actions & Billing Rules

Documentation Required

Document medical necessity criteria

Document that the individual's medical records meet medical necessity criteria. Required elements include: diagnosis/condition; history and physical documenting severity; NYHA heart failure class; documentation of operability or high surgical risk; and confirmation that the chosen transcatheter heart valve system is FDA-approved and will be used in a manner consistent with FDA labeling.

Required elements: diagnosis/condition; history & physical with severity; NYHA class; operability/high surgical risk documentation; device FDA-approved and use consistent with labeling.

Documentation Required

Operability / surgical risk documentation

For valve-in-valve (ViV) procedures and situations where increased surgical risk must be shown, documentation of operability and surgical risk is required from at least two cardiovascular specialists, one of whom must be a cardiac surgeon. When the STS score does not capture elevated risk, narrative documentation from two cardiovascular specialists (including a cardiac surgeon) must describe the specific factors that increase surgical risk.

At least 2 cardiovascular specialists, including a cardiac surgeon, must document operability or increased surgical risk for ViV.

Background, Evidence and Guideline Excerpts

Background: Transcatheter aortic valve replacement (TAVR/TAVI) was developed as a less invasive alternative to surgical aortic valve replacement for individuals with symptomatic severe aortic stenosis and originally targeted patients at prohibitive or high surgical risk. Randomized trials and observational studies over time have demonstrated benefit across surgical risk strata (prohibitive/extreme, high, intermediate, and low), supporting expanded indications in selected patients, while also identifying procedure‑specific risks such as stroke, vascular complications, and higher pacemaker rates with some valve types. Valve‑in‑valve (ViV) TAVI is used to treat failure of surgical bioprosthetic valves and observational data and registry analyses show favorable short‑term outcomes compared with redo surgical replacement, though randomized trials are lacking and long‑term comparative evidence is limited. There remains an unmet need for less invasive options for individuals who are poor operative candidates. In this context, cerebral embolic protection (CEP) devices have been studied but randomized trials and meta‑analyses have not consistently shown reduced clinical stroke or improved net health outcomes; therefore, CEP use during TAVR is considered investigational in this policy.

Recommendations for AVR (from guideline excerpts)

Statements summarize guideline classes of recommendation and levels of evidence for indications and device selection:

In apparently asymptomatic patients with severe AS (Stage C1) and low surgical risk, AVR is reasonable when the serum B-type natriuretic peptide level is >3 times normal.

Class IIa; LOE B

Definitions

Term	Definition
Severe aortic stenosis
Presence of one or more: aortic valve area <=1.0 cm2; indexed valve area <=0.6 cm2/m2; mean gradient >=40 mm Hg; peak aortic-jet velocity >=4.0 m/s.
Extreme risk/inoperable
FDA: Predicted risk of operative mortality and/or serious irreversible morbidity >=50% for open surgery.
High risk for open heart surgery
STS predicted operative risk score >=8% or judged by a heart team to have expected mortality risk >=15% for open surgery.
Intermediate risk
STS predicted operative risk score 3% to 7%.
NYHA classes
Class II: mild symptoms; Class III: marked limitation; Class IV: severe limitation/symptoms at rest.
AVR
Aortic valve replacement (surgical or transcatheter)
SAVR
Surgical aortic valve replacement
TAVI/TAVR
Transcatheter aortic valve implantation/replacement
ViV
Valve-in-valve transcatheter procedure for bioprosthetic valve dysfunction
VKA
Vitamin K antagonist (oral anticoagulation)
NYHA
New York Heart Association functional class
ViV TAVI
Valve-in-valve transcatheter aortic valve implantation for treatment of degenerated surgical bioprostheses.
STS score
Society of Thoracic Surgeons predicted risk of mortality score used to stratify surgical risk.

Revision History

02/27/12policy_created

New policy created (7.01.132) — medically necessary for patients who are not surgical candidates; investigational for other indications.

12/23/13coding_update

Coding update: added CPT 33366; discontinued codes 0256T–0259T and removed unlisted code 93799 (historical coding changes).

02/11/13policy_replaced

Policy replaced prior version; added medically necessary indications for high-risk patients and investigational statement for valve-in-valve and nonstandard vascular approaches.

Medicare Determinations

Year	Name	Type	Number
2012
Centers for Medicare & Medicaid Services decision memo for Transcatheter Aortic Valve Replacement (TAVR)
NCD (Medicare decision memo)
CAG-00430R (CMS decision memos 2012 and 2019 summarized under CAG-00430R)
2019
TAVR coverage decision memo update (CMS)
NCD (Medicare decision memo)
CAG-00430R (referenced as CMS decision memos 2012 and 2019)

Policy Summary

PayerPremera Bluecross

PolicyTranscatheter Aortic-Valve Implantation for Aortic Stenosis

Policy CodePolicy 7.01.132

Change TypeMultiple: administrative, clarifications, additions, coding update

Effective Date

Next Review Date

SourceLink

On This Page

Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve
New York Heart Association heart failure class II, III, or IV symptoms
AND one of the following documented by at least 2 cardiovascular specialists (including a cardiac surgeon):
- Individual is not an operable candidate for open surgery
- Individual is an operable candidate but is considered at increased surgical risk for open surgery
- Individual is considered at increased surgical risk for open surgery due to congenital vascular anomalies and/or a complex intrathoracic surgical history

TAVR/TAVI valve-in-valve (degenerate bioprosthetic valve) - Medical Necessity

Covered when ALL of the following are present:

Failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve

New York Heart Association heart failure class II, III, or IV symptoms

AND one of the following documented by at least 2 cardiovascular specialists (including a cardiac surgeon):

Individual is not an operable candidate for open surgery
Documented by at least 2 cardiovascular specialists (including a cardiac surgeon)
Individual is an operable candidate but is considered at increased surgical risk for open surgery
Documented by at least 2 cardiovascular specialists (including a cardiac surgeon)
Individual is considered at increased surgical risk for open surgery due to congenital vascular anomalies and/or a complex intrathoracic surgical history
Documented by at least 2 cardiovascular specialists (including a cardiac surgeon)

Special Consideration for Increased Surgical Risk not captured by STS score

Covered when ALL of the following are met:

Individual is considered at increased surgical risk for open surgery (e.g., repeat sternotomy) due to a history of congenital vascular anomalies AND/OR has a complex intrathoracic surgical history.

Documented by at least 2 cardiovascular specialists (including a cardiac surgeon).

When STS score is not demonstrative, two specialists must document additional risk factors (advanced age, complex intrathoracic history, congenital anomalies, liver disease, other comorbidities).

Documentation Required

Heart team involvement and registry participation (Medicare conditions)

Medicare-specific conditions require documented heart team involvement and, when applicable, participation in a prospective registry as a condition of coverage. Ensure records show heart team evaluation and registry enrollment when Medicare policy requires it.

Document heart team evaluation.
Document participation in applicable prospective registry when required by Medicare conditions of coverage.

Documentation Required

Joint intraoperative participation (Medicare requirement)

For Medicare-covered transcatheter aortic valve procedures, joint intraoperative participation by both the interventional cardiologist and the cardiac surgeon is required; document the participation of both specialists in the operative record.

Document intraoperative participation of both interventional cardiologist and cardiac surgeon per Medicare requirement.

Billing Rule

Report add-on cardiopulmonary bypass support codes separately

Report add-on cardiopulmonary bypass support codes separately when used; code descriptions note that these are listed separately in addition to the primary TAVR procedure.

Report separately: CPT 33367, 33368, 33369 (cardiopulmonary bypass support; percutaneous, open peripheral, central).

Billing Rule

Cerebral embolic protection coding

Cerebral embolic protection devices and their placement codes are listed in coding resources but use during TAVR is considered investigational per policy. If billed, report device and placement codes separately; coverage decision is investigational.

Related codes: CPT 33370 (placement/removal of cerebral embolic protection device), HCPCS C1884 (Embolization protective system), HCPCS C8010 (percutaneous permanent carotid embolic protection device, bilateral; effective 2026-04-01).
Policy status: Use of cerebral embolic protection devices during TAVR is considered investigational.

Billing Rule

Use devices per FDA labeling

Devices must be FDA-approved for the indication and used in a manner consistent with the device's FDA-approved labeling. Ensure documentation states the device is FDA-approved for the intended use and that the procedural approach aligns with labeling.

Policy follows current literature and coding updates; use only FDA-approved transcatheter heart valve systems per labeling and document alignment with labeling.

Documentation Required

Comprehensive Valve Center requirement for ViV and complex procedures

Valve-in-valve (ViV) and other complex transcatheter procedures should be performed at Comprehensive Valve Centers with the required multidisciplinary infrastructure. Document center designation and that appropriate program resources and subspecialty expertise are available.

Comprehensive Valve Center requirement for ViV and complex procedures; document center capabilities and multidisciplinary support.

Documentation Required

Document increased surgical risk when STS score not demonstrative

When STS score underestimates risk, document increased surgical risk with attestation from at least two cardiovascular specialists (including a cardiac surgeon) describing specific reasons risk is elevated (e.g., repeat sternotomy, congenital anomalies, complex intrathoracic history).

At least 2 cardiovascular specialists, including a cardiac surgeon, must document increased surgical risk when STS score is not demonstrative.

Intervention for Prosthetic Valve Stenosis and Regurgitation

Statements summarize guideline classes of recommendation and levels of evidence for indications and device selection:

In patients with symptomatic severe stenosis of a bioprosthetic or mechanical prosthetic valve, repeat surgical intervention is indicated unless surgical risk is prohibitive.

Class I; LOE B

For severely symptomatic patients with bioprosthetic aortic valve stenosis and high or prohibitive surgical risk, a transcatheter ViV procedure is reasonable when performed at a Comprehensive Valve Center.

Class IIa; LOE B

For patients with significant bioprosthetic valve stenosis attributable to suspected or documented valve thrombosis, oral anticoagulation with a VKA is reasonable.

Class IIa; LOE B

In patients with intractable hemolysis or heart failure attributable to prosthetic transvalvular or paravalvular leak, surgery is recommended unless surgical risk is high or prohibitive.

Class I; LOE B

In asymptomatic patients with severe prosthetic regurgitation and low operative risk, surgery is reasonable.

Class IIa; LOE B

Evidence Item	Summary
RCT evidence for prohibitive/high/intermediate/low risk
Multiple RCTs (PARTNER trials, CoreValve trials, SURTAVI, PARTNER 3, Evolut Low Risk, NOTION, EARLY TAVR, others) and systematic reviews showing TAVR improves or is noninferior to SAVR across risk strata; net health benefit supported for many risk groups; details summarized in policy (see PARTNER, CoreValve, SURTAVI, PARTNER 3, Evolut Low Risk trials).
CEP device trials
Multiple RCTs and meta-analyses of cerebral embolic protection devices (eg, CLEAN-TAVI, MISTRAL-C, PROTECTED TAVR and other trials); largest trials and meta-analyses did not demonstrate reduced periprocedural stroke or consistent clinical benefit — evidence insufficient to support improvement in net health outcome.
Guideline references
2020 ACC/AHA valvular heart disease guideline recommendations (Class I/IIa/IIb with LOE A/B/C) on timing and choice of AVR, and recommendations supporting TAVR in high/prohibitive risk and selected intermediate/low risk patients; guideline excerpts summarized in policy.
Medicare decision memo
CMS decision memos (2012 and 2019) including CAG-00430R: coverage when FDA indications met and conditions (heart team, registry participation, hospital qualifications, joint intraoperative participation) are satisfied; memo summarized in policy.
NICE guidance
NICE IPG653 (2019) and NG208 (2021) support ViV-TAVI with standard governance/audit and recommend TAVI when SAVR contraindicated or patient at high surgical risk.
Key literature cited (examples)
Numerous randomized trials and meta-analyses (eg, PARTNER series, CoreValve pivotal trials, NOTION, SURTAVI) and multiple systematic reviews referenced in the policy evidence review supporting clinical outcomes and durability data.

05/01/17annual_review

Annual review; literature updated through Dec 22, 2016; policy statements unchanged.

07/02/20policy_deleted_replaced

Policy deleted effective July 2, 2020 and replaced with InterQual criteria for dates of service on or after July 2, 2020.

11/01/20policy_reinstated

Policy reinstated effective February 5, 2021; statements unchanged.

01/01/22renumber_and_added_investigational_statement

Policy renumbered; added statement that use of a cerebral embolic protection device during TAVR procedures is considered investigational and added CPT 33370 and HCPCS C1884.

05/01/23renumber

Policy renumbered to 7.01.132 from 7.01.585; minor editorial refinements; intent unchanged.

05/01/24annual_review

Annual review — removed the left ventricular ejection fraction >20% requirement for TAVI and ViV TAVI; added statement for consideration of individuals at increased surgical risk not demonstrated by STS score requiring documentation from at least 2 cardiovascular specialists including a cardiac surgeon (is_material true).

08/01/25annual_review

Annual review (approved July 7, 2025); policy updated with literature through March 14, 2025; policy statements unchanged.

04/01/26coding_updateLatest

Coding update: HCPCS code C8010 added effective April 1, 2026.

05/01/24material_change

For TAVI and ViV TAVI, the criterion of left ventricular ejection fraction greater than 20% was removed (is_material true).

05/01/24material_change

Statement added for consideration of individuals at increased surgical risk not demonstrated on STS score; requires documentation by at least 2 cardiovascular specialists including a cardiac surgeon (is_material true).

01/01/22material_change

Use of a cerebral embolic protection device during TAVR considered investigational (added when policy renumbered; is_material true).