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Transcatheter pulmonary valve implantation (TPVI) received approval from the U.S. Food and Drug Administration (FDA) under the Humanitarian Device Exception program in January 2010 for patients with previous repair of congenital heart disease (CHD) and right ventricular outflow tract (RVOT) obstruction. Patients with prior congenital heart disease repair are at risk of needing repeated reconstruction procedures. TPVI has been proposed as a less invasive alternative to open surgical pulmonary valve replacement or reconstruction for right ventricular outflow tract obstruction.
Description of Disease. Congenital heart disease, including tetrology 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 by means of a surgical homograft or a bovine-derived valved conduit. These repairs are prone to development of pulmonary stenosis or regurgitation over long periods of follow-up.
As individuals with surgically corrected congenital heart disease repair are living longer into adulthood, the problem of 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.
Interventions for RVOT dysfunction often require repeat open heart surgery, resulting to numerous open heart procedures for patients who live into adulthood. Treatment options for pulmonary stenosis are open surgery with valve replacement, balloon dilatation, or percutaneous stenting. Interventions for pulmonary regurgitation are primarily surgical, either reconstruction of the RVOT conduit or replacement of the pulmonary valve through open surgery. The optimal timing of these interventions is not well understood.
Transcatheter pulmonary valve replacement offers a potentially less invasive treatment option for patients with prior surgery for congenital heart disease and RVOT dysfunction. It is possible that the use of less invasive valve replacement techniques can spare patients from multiple repeat open heart procedures over long periods of follow-up.
Description of Technology. The Melody® transcatheter pulmonary valve and the Ensemble® Transcatheter Valve Delivery System are used together for percutaneous replacement of a dysfunctional pulmonary valve. The Melody valve consists of a section of bovine jugular vein with an intact native venous valve. The valve and surrounding tissue is sutured within a platinum-iridium stent scaffolding. The transcatheter delivery system consists of a balloon-in-balloon catheter with a retractable sheath and distal cup into which the valve is placed. The procedure is performed on the beating heart without use of cardiopulmonary bypass.
The Melody valve is first crimped to fit into the delivery system. It is introduced through the femoral vein and advanced into the right side of the heart and put into place at the site of the pulmonary valve. The inner balloon is inflated to open up the artificial valve, and then the outer balloon is inflated to position the valve into place.
The Edwards SAPIEN Pulmonic Transcatheter Heart Valve, composed of a stainless steel frame with bovine pericardial tissue leaflets and available in 23 and 26 mm sizes, is CE-marked for use in Europe, but does not have FDA- approval for use in the United States.
The Melody® transcatheter pulmonary valve and the Ensemble® Transcatheter Valve Delivery System, manufactured by Medtronic (Minneapolis, MN), received FDA approval under the Humanitarian Device Exemption (HDE) Program on January 25, 2010. Approval was for use as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:
In 2015, approval of the Melody device was amended to a premarket approval (PMA) because FDA determined that the device represents a breakthrough technology. The PMA was based, in part, on two prospective clinical studies, the Melody TPV Long-term Follow-up Post Approval Study (PAS) and the Melody TPV New Enrollment PAS.
POLICYTranscatheter pulmonary valve implantation, when performed according to FDA-approved indications, is considered medically necessary for patients with prior repair of congenital heart disease and right ventricular outflow tract (RVOT) dysfunction, who are not good candidates for open repair due to one or more of the following conditions:
Transcatheter pulmonary valve implantation is considered investigational for all other indications.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY03/22/2012: 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 added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.131
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.