Description

The transcatheter or percutaneous approach was developed as an alternative to traditional open-heart surgery for a number of interventions, including valve replacement or repair. The heart contains four valves which enable efficient circulation of blood: aortic, mitral, pulmonary and tricuspid.

Aortic Valve

The aortic valve closes off the left ventricle (lower chamber) that holds oxygenated blood before it pumps out to the body, then opens to allow the blood to exit the heart. Aortic stenosis (narrowing) and aortic regurgitation (leaking) may require valve replacement. Both conditions increase the workload of the heart and decrease function. The gold standard for preimplant planning for an eligible individual is computed tomography angiography (CTA) of the heart to measure the aortic annulus (fibrous ring at the aortic orifice). Transthoracic echocardiography (TTE) is used to determine left ventricular function, valve stenosis severity, presence of other valve disease or pulmonary hypertension. Transesophageal echocardiography (TEE) is an alternative to CTA for sizing the annulus in an individual with renal insufficiency.

In transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement (TAVR), a bioprosthetic valve is delivered by catheter through a peripheral artery and implanted into the existing valve. Once the prosthetic valve is deployed, angiography, CTA or echocardiography is conducted to ensure successful implantation of the device.

A number of transcatheter aortic valves have been developed for use in an individual with severe aortic stenosis and determined by a heart team (including a cardiac surgeon and an interventional cardiologist) to be at risk for open-heart surgery. Examples of US Food & Drug Administration (FDA)-approved transcatheter aortic valves for use at varying risk levels include, but may not be limited to:

• All risk levels (low, intermediate, high or prohibitive): Edwards Sapien Systems (Sapien 3, Sapien 3 Ultra, Sapien 3 Ultra Resilia) and Medtronic CoreValve Evolut Systems (Evolut FX, Evolut PRO+, Evolut R)
• High or prohibitive (inoperable) risk: Abbott TAVI Systems (Navitor, Portico)

Mitral Valve

The mitral valve closes the heart’s left atrium (upper chamber) which collects the oxygenated blood from the lungs, then opens to allow blood to pass into the left ventricle (lower chamber). Mitral valve prolapse occurs when the flap-like leaflets of the valve bulge into the left atrium preventing even closure. In some cases, the prolapse results in regurgitation (blood leaks backward through the valve) which may cause a heart murmur. In mitral stenosis, the valve becomes narrowed and restricts blood flow from the left atrium to the left ventricle. Both mitral valve regurgitation and stenosis may require mitral valve repair if an individual is symptomatic.

Transcatheter edge-to-edge repair (TEER) of the mitral valve is indicated for the percutaneous reduction of symptomatic mitral regurgitation (MR) in the individual who is deemed at prohibitive risk by a cardiac surgeon for open mitral valve surgical procedures.

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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repair. During this procedure, a mechanical clip grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. This repair occurs without the need for arresting the heart or cardiopulmonary bypass. Examples of FDA-approved mitral valve TEER systems include, but may not be limited to, the MitraClip G4 System and the PASCAL Precision System. Depending upon the valve anatomy, it may be necessary to use more than one clip during the procedure.

Transcatheter mitral valve implantation (TMVI) or replacement is currently under investigation as an alternative to open surgical mitral valve replacement. The procedure is performed via a transcatheter approach including a transseptal puncture under general anesthesia. A stent-based prosthesis is implanted within the native mitral annulus via catheter threaded through the inferior vena cava to the right atrium where the septum is punctured to gain access to the left atrium. There are currently no FDA-approved devices for TMVI. (Refer to Coverage Limitations section)

Annuloplasty (annulus reconstruction) is a surgical procedure to tighten, reshape or reinforce the mitral annulus (ring around the valve) to enable effective leaflet function. Flexible rings or bands may be implanted to improve the structure of the valve. Transcatheter approaches and devices (eg, Carillon Mitral Contour System) are under investigation as an alternative to surgical annuloplasty. A percutaneously deployed annuloplasty device is placed into the mitral valve annulus through the coronary sinus to purportedly reduce mitral regurgitation. There are currently no devices approved by the FDA for transcatheter annuloplasty. (Refer to Coverage Limitations section)

The mitral valve contains chordae tendineae (thread-like bands of fibrous tissue) which serve to anchor the leaflets in place. During some types of mitral valve repair procedures, chordae tendineae may be transplanted or artificial replacements may be implanted. (Refer to Coverage Limitations section)

Pulmonary Valve

The pulmonary or pulmonic valve opens and closes the heart's right ventricle (lower chamber) to pump blood via the pulmonary artery from the heart to the lungs where it is oxygenated. The pulmonary valve may require replacement for pulmonary stenosis (narrowing) or regurgitation (leaking).

Percutaneous pulmonary valve implantation (PPVI) devices are used to prolong the life span of failing prosthetic pulmonary conduits in an individual with congenital heart defects. The PPVI is not expected to replace the initial open-heart surgery for placement of a pulmonary conduit, but it is expected to reduce the total number of open-heart right ventricular outflow tract (RVOT) procedures over an individual’s lifetime. Harmony, Melody and Sapien 3 transcatheter pulmonary valves are examples of FDA-approved devices.

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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(Refer to Coverage Limitations section)

Tricuspid Valve

The tricuspid valve closes the right atrium (upper chamber) where blood enters from the body, then opens to allow blood to flow to the right ventricle (lower chamber), while preventing backflow when pumped out of the ventricle. Tricuspid regurgitation (leaking) or stenosis (narrowing) may result from an improperly functioning tricuspid valve. Tricuspid annuloplasty (valve repair), reconstruction or replacement via transcatheter approach is being studied as a treatment for tricuspid regurgitation. This is currently in preclinical or early clinical trials and not yet available for general use. Transcatheter tricuspid valve repair or replacement generally includes right heart catheterization, temporary pacemaker insertion and selective right ventricular or right atrial angiography during the procedure. (Refer to Coverage Limitations section)

Transcatheter caval valve implantation (CAVI) is an investigational technique proposed to relieve the symptoms of severe tricuspid regurgitation (eg, ascites, dyspnea, fatigue, lower extremity edema) without repairing or replacing the tricuspid valve. This is accomplished by implanting a valve in the inferior vena cava (IVC) alone or in combination with a second valve in the superior vena cava (SVC) to redirect the regurgitant blood flow from the failing tricuspid valve. There are no FDA-approved CAVI devices available for general use. (Refer to Coverage Limitations section)

Paravalvular leaks may occur as a complication of surgical or transcatheter aortic or mitral valve replacement, when the seal between the valve annulus and the prosthetic valve becomes separated. Regurgitation of blood may occur, and large leaks could lead to heart failure or endocarditis. Percutaneous transcatheter repair of paravalvular leaks has been successfully performed; however, there are currently no FDA-approved devices for this indication. (Refer to Coverage Limitations section)

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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Valve-in-valve (V-in-V) procedures are performed to replace previously implanted surgical or transcatheter cardiac valves that have failed or degenerated over time. These may be replaced using transcatheter access.

Examples of FDA-approved devices for V-in-V procedures for the individual deemed at high or greater risk for surgical valve replacement include, but may not be limited to:

• Aortic: CoreValve systems (Evolut FX, Evolute PRO+, Evolut R), Sapien 3, Sapien 3 Ultra, Sapien 3 Ultra Resilia
• Mitral: Sapien 3, Sapien 3 Ultra, Sapien 3 Ultra Resilia (Refer to Coverage Limitations section)
• Pulmonic/Tricuspid: No FDA-approved devices. (Refer to Coverage Limitations section)

Embolic protection devices are purported to capture and remove thrombus or debris while transcatheter aortic valve replacement procedures are performed. These devices are single use percutaneous catheters with a blood filter at the distal end.

Sentinel and TriGuard 3 are examples of such devices, although only Sentinel is currently FDA approved for commercial use. (Refer to Coverage Limitations section)

Coverage Determination

Transcatheter Aortic Valve Procedures

Humana members may be eligible under the Plan for TAVI or TAVR when ALL of the following criteria are met:

• Absence of any contraindications; AND
• Candidate for TAVI/TAVR as determined by a heart team (including a cardiac surgeon and interventional cardiologist); AND
• Existing comorbidities would not preclude the expected benefit from correction of the aortic stenosis; AND

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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• FDA-approved aortic valve and implantation system to be utilized in accordance with FDA labeling; AND
• Left ventricular ejection fraction (LVEF) greater than 20%; AND
• Life expectancy greater than 1 year; AND
• Severe symptomatic native calcific aortic stenosis as indicated by ANY of the following:
• Aortic valve area less than 1.0 cm2; OR
• Aortic valve area index less than or equal to 0.6 cm2m2; OR
• Mean aortic valve gradient greater than or equal to 40 mmHg; OR
• Peak aortic jet velocity greater than or equal to 4.0 m/s

Humana members may be eligible under the Plan for transcatheter V-in-V revision of surgical or transcatheter aortic valve replacement when the following criteria are met:

• FDA-approved aortic valve and implantation system to be utilized in accordance with FDA labeling; AND
• High risk (Society of Thoracic Surgery [STS] predicted risk of mortality [PROM]) greater than or equal to 8% for open aortic surgical therapy as determined by a heart team (including a cardiac surgeon and interventional cardiologist); AND
• EITHER of the following:
• Degenerated and failed previously implanted bioprosthetic aortic valve; OR
• As a bailout procedure for aortic valve prosthesis embolization, aortic valve leaflet coronary occlusion or aortic paravalvular leakage (PVL)

Note: The criteria for transcatheter valve procedures are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Limitations

Humana members may NOT be eligible under the Plan for TAVI or TAVR for any indications other than those listed above including, but not limited to, the following contraindications:

• Active infection (eg, bacterial endocarditis); OR
• Acute myocardial infarction (MI) less than or equal to 1 month prior to planned TAVR; OR
• Congenital unicuspid aortic valve; OR
• Echocardiographic evidence of ANY of the following:
  • Intracardiac mass; OR
  • Thrombus in an individual with high risk for embolization during the TAVI/TAVR procedure as determined by a heart team (including a cardiac surgeon and interventional cardiologist); OR
  • Vegetation; OR
• Inability to tolerate anticoagulation or an antiplatelet regimen; OR
• Magnetic resonance imaging (MRI) confirmed cerebral embolic event with extensive neurological damage or intracranial hemorrhage within 4 weeks of planned TAVI/TAVR; OR
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation [AR] with predominant AR greater than 3+) when anatomy is unfavorable (as defined by TEE); OR
• Noncalcified aortic annulus; OR
• Severe pulmonary hypertension (mean pulmonary artery pressure (mPAP) greater than 20 mmHg and/or pulmonary vascular resistance greater than 2 Wood units) when medication is contraindicated, ineffective or not tolerated14,69;
• Determined by the heart team (including a cardiac surgeon and interventional cardiologist) to be unlikely to benefit from aortic valve replacement; AND
• Right ventricular dysfunction (pressure and/or volume overload); OR
• Significant aortic disease when alternate nonfemoral access (carotid, direct aortic, subclavian/axillary, transcaval) is not available and with ANY of the following1,97:
  • Abdominal aortic or thoracic aneurysm with maximal luminal diameter 5 cm or greater; OR
  • Aortic arch atheroma (greater than 5 mm, protruding or ulcerated); OR
  • Narrowing (with calcification and surface irregularities) of the abdominal or thoracic aorta; OR
  • Severe unfolding and tortuosity (bends, turns or twists) of the abdominal or thoracic aorta; OR
• Symptomatic hypertrophic cardiomyopathy (HCM) with or without obstruction when symptoms (eg, chest pain, dyspnea, fatigue, palpitations) are due to HCM and not due to aortic stenosis as determined by a heart team (including a cardiac surgeon and interventional cardiologist)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for transcatheter V-in-V revision of surgical or transcatheter aortic valve replacement for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Coverage Determination

Transcatheter Mitral Valve Procedures

Humana members may be eligible under the Plan for transcatheter edge-to-edge repair (TEER) of the mitral valve when the following criteria are met:

• Absence of any contraindications; AND
• Favorable anatomy (as defined by TEE) for the repair procedure; AND
• Life expectancy greater than 1 year; AND

using either of the following FDA-approved devices:

• MitraClip G4 System:
• Chronic degenerative (primary) moderate-severe to severe (3+ to 4+) MR when determined by a heart team (including a cardiac surgeon and an interventional cardiologist) to be at prohibitive surgical risk*; OR
• Chronic functional (secondary) moderate-severe to severe (3+ to 4+) MR with symptomatic (New York Heart Association Class III or IV) heart failure despite optimal individualized guideline-directed medical therapy (GDMT)**; OR
• PASCAL Precision System:
• Chronic degenerative (primary) moderate-severe to severe (3+ to 4+) MR when determined by a heart team (including a cardiac surgeon and an interventional cardiologist) to be at prohibitive surgical risk*

Prohibitive surgical risk is defined as one or more of the following risk factors:

• STS predicted risk of operative mortality (STS PROM) score greater than or equal to 8% for isolated open surgical mitral valve (MV) replacement64,100; OR
• STS predicted risk of operative mortality (STS PROM) score greater than or equal to 6% for isolated open surgical MV repair64,100; OR
• Presence of one or more clinical features not captured in the STS-PROM risk calculator algorithm that adds heightened open surgical risk (eg, abnormal chest anatomy, frailty, porcelain aorta, severe liver disease with Model for End-stage Liver Disease [MELD] score greater than 12, severe pulmonary hypertension [mPAP greater than 20 mmHg and/or pulmonary vascular resistance greater than 2 Wood units])14,78,100

**GDMT represents individualized optimal medical therapy and lifestyle modifications for heart failure and may include the following:

• Aldosterone antagonists
• Angiotensin-converting enzyme inhibitors (ACEI)
• Angiotensin receptor blockers (ARB)
• Angiotensin receptor-neprilysin inhibitors (ARNI)7
• Beta blockers
• Diuretics
• Ivabradine7
• Nitrates
• SLGT2 inhibitors7
• Lifestyle modifications (eg, diet, exercise, smoking cessation, weight loss)

Note: The criteria for transcatheter valve procedures are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members.

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for TEER for any indications other than those listed above including, but not limited to, the following contraindications:

• Active endocarditis of the mitral valve; OR
• Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus99,100; OR
• Inability to tolerate procedural anticoagulation or post procedural anti-platelet regimen; OR
• Rheumatic mitral valve disease; OR

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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• Untreatable hypersensitivity or contraindication to nitinol (nickel and titanium) or contrast media

These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following mitral valve procedures:

• TMVI or replacement; OR
• Transapical mitral valve repair with placement of artificial chordae tendineae; OR
• Transcatheter implantation or replacement of previously implanted mitral valves that have failed (V-in-V); OR
• Transcatheter mitral valve annuloplasty; OR
• Transcatheter mitral valve annulus reconstruction with implantation of adjustable annulus device; OR
• Transcatheter mitral valve repair via coronary sinus approach (eg, Carillon Mitral Contour System); OR
• Transcatheter repair of paravalvular leak of mitral valves

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Determination

Percutaneous Pulmonary Valve Implantation (PPVI)

Humana members may be eligible under the Plan for PPVI using one of the FDA-approved devices below in the management of the pediatric or adult individual, when the following criteria are met:

Transcatheter Valve Procedures

Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027

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• Harmony Transcatheter Pulmonary Valve System:
• Dysfunctional native or surgically repaired RVOT conduit with a clinical indication for intervention as indicated by EITHER of the following:
  • Pulmonary regurgitant fraction greater than or equal to 30% on cardiac magnetic resonance imaging; OR
  • Severe pulmonary regurgitation on echocardiogram (regurgitant jet width greater than 50% of pulmonic valve annulus)17,81; OR
• Melody Transcatheter Pulmonary Valve System:
• Dysfunctional RVOT conduit with a clinical indication for intervention as indicated by:
  • Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted; AND either of the following
    • Regurgitation: greater than or equal to moderate (regurgitant jet width less than 50% of pulmonic valve annulus)17,81 on echocardiogram; OR
    • Stenosis: mean RVOT gradient greater than or equal to 35 mmHg

Note: The criteria for transcatheter valve procedures are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Coverage Limitations

Humana members may NOT be eligible under the Plan for PPVI for any indications other than those listed above. This is considered experimental/investigational as it is not identified as widely used and generally accepted for any other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for the following when used for the pulmonary valve:

Transcatheter Valve Procedures
Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027
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• Sapien 3 valve; OR
• Transcatheter implantation or replacement of previously implanted pulmonary valves that have failed (V-in-V); OR
• Transcatheter repair of paravalvular leak of pulmonary valves

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Determination

Transcatheter Tricuspid Valve Procedures

Humana members may NOT be eligible under the Plan for the following:

• Transcatheter caval valve implantation (CAVI); OR
• Transcatheter implantation or replacement of previously implanted tricuspid valves that have failed (V-in-V); OR
• Transcatheter repair of paravalvular leak of tricuspid valves; OR
• Transcatheter tricuspid valve annulus reconstruction with implantation of adjustable annulus device; OR
• Transcatheter tricuspid valve repair or replacement

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Note: The criteria for transcatheter valve procedures are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Transcatheter Valve Procedures
Effective Date: 4/27/2023
Revision Date: 4/27/2023
Review Date: 04/27/2023
Policy Number: HUM-0508-027
Page: 14 of 31

Humana's documents are updated regularly online.

When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may NOT be eligible under the Plan for cerebral protection systems (eg, Sentinel Cerebral Protection System, TriGuard 3). These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Coverage Determination

Note: The criteria for transcatheter valve procedures are not consistent with the Medicare National Coverage Policy, and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Additional information about cardiac valvular conditions may be found from the following websites:

Background

• American Association for Thoracic Surgery
• American College of Cardiology
• American Heart Association
• National Library of Medicine

Medical Alternatives

Alternatives to transcatheter valve procedures include, but may not be limited to, the following:

• Surgical valve replacement or repair

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.