Transcatheter Pulmonary Valve Implantation

POLICY NUMBER

A.7.01.131

DESCRIPTION

Transcatheter pulmonary valve implantation (TPVI) is a less invasive alternative to open surgical pulmonary valve replacement or reconstruction for right ventricular outflow tract (RVOT) obstruction. Percutaneous pulmonary valve replacement may be indicated for congenital pulmonary stenosis. Pulmonary stenosis or regurgitation in a patient with congenital heart disease who has previously undergone RVOT surgery are additional indications. Patients with prior congenital heart disease repair are at risk of needing repeated reconstruction procedures.

Congenital Heart Disease

Congenital heart disease, including tetralogy of Fallot, pulmonary atresia, and transposition of the great arteries, is generally treated by surgical repair at an early age. This involves reconstruction of the right ventricular outflow tract (RVOT) and pulmonary valve using a surgical homograft or a bovine-derived valve conduit. These repairs are prone to development of pulmonary stenosis or regurgitation over long periods of follow-up. Individuals living with congenital heart disease also face disparities in social determinants of health and the inability to obtain quality lifelong care for their condition which can contribute to inequities in morbidity and mortality.

Because individuals with surgically corrected congenital heart disease repair are living into adulthood, RVOT dysfunction following initial repair has become more common. Calcification of the RVOT conduit can lead to pulmonary stenosis, while aneurysmal dilatation can result in pulmonary regurgitation. RVOT dysfunction can lead to decreased exercise tolerance, potentially fatal arrhythmias, and/or irreversible right ventricular dysfunction.

Treatment

Treatment options for pulmonary stenosis are open surgery with valve replacement, balloon dilatation, or percutaneous stenting. The established interventions for pulmonary regurgitation are primarily surgical, either reconstruction of the RVOT conduit or replacement of the pulmonary valve. The optimal timing of these interventions is not well understood.

Devices for transcatheter pulmonary valve implantation were initially cleared from marketing by the U.S. Food and Drug Administration (FDA) through the humanitarian device exemption (HDE) process or used off-label until approved by the FDA through the premarket approval (PMA) process (see the table below).

Regulatory Status of Transcatheter Pulmonary Valve Implantation Devices

In January 2010, the Melody® TPV and the Ensemble® Transcatheter Valve Delivery System (Medtronic) were approved by the FDA under the Humanitarian Device Exemption (HDE) Program for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:

On January 27, 2015, approval of the Melody system was amended to a premarket approval (PMA) because the FDA determined that the device represented a breakthrough technology. The PMA was based, in part, on two prospective clinical studies, the Melody TPV Long-term Follow-up Post Approval Study and the Melody TPV New Enrollment Post Approval Study.

On February 24, 2017, approval of the Melody system was expanded to include patients with a dysfunctional surgical bioprosthetic valve (valve-in-valve).

The Edwards SAPIEN XT™ Transcatheter Heart Valve (Pulmonic) (Edwards Lifesciences) was approved by the FDA in 2016 "for use in pediatric and adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and:

The approval for the pulmonic valve indication is a supplement to the 2014 PMA for use of the Edwards SAPIEN XT Transcatheter Heart Valve System for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis and who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (ie, Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).

The Harmony™ Transcatheter Pulmonary Valve (Medtronic) received breakthrough technology status in 2019 and PMA in 2021. This device is indicated "for use in pediatric and adult patients with severe pulmonary regurgitation (determined by echocardiography and/or pulmonary regurgitant fraction ≥30% by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement."

FDA product code: NPV

POLICY

Transcatheter pulmonary valve implantation with a Food and Drug Administration-approved valve is considered medically necessary for individuals with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:

• Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation;

• Individuals with native or patched RVOT with at least moderate pulmonic regurgitation;

• Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); or

• Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg).

Transcatheter pulmonary valve implantation is considered investigational for all other indications.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

03/22/2012: Approved by Medical Policy Advisory Committee.

02/20/2013: Added the verbiage "when performed according to FDA-approved indications" to the medically necessary policy statement.

03/05/2014: Policy reviewed; no changes.

12/22/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged. 

08/27/2015: Code Reference section updated to add ICD-10 codes.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to add new 2016 CPT code 33477.

01/05/2016: Policy description updated regarding devices. Policy statements unchanged.

05/31/2016: Policy number A.7.01.131 added.

08/18/2016: Policy description updated regarding devices. Policy statements unchanged.

12/22/2017: Removed deleted CPT code 0262T.

06/20/2018: Policy description updated regarding devices. Policy statement revised to state that transcatheter pulmonary valve implantation is considered medically necessary for patients with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the specified indications. It previously stated: Transcatheter pulmonary valve implantation, when performed according to FDA-approved indications, is considered medically necessary for patients with prior repair of congenital heart disease and RVOT dysfunction, who are not good candidates for open repair due to certain conditions.

07/17/2019: Policy reviewed; no changes.

07/15/2020: Policy reviewed; no changes.

04/18/2022: Policy description updated regarding devices. Medically necessary policy statement updated to specify FDA-approved devices. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

07/15/2022: Policy description updated regarding individuals living with congenital heart disease. Policy statement updated to change "patients" to "individuals."

08/02/2023: Policy reviewed; no changes.

07/24/2024: Policy reviewed; no changes.

08/22/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.131

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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