Medical Policy
Effective Date:09/01/2012 Title:Transcatheter Pulmonary Valve Implantation (TPVI)
Revision Date:08/02/2017 Document:BI365:00
CPT Code(s):0262T
Public Statement

Effective Date:

A)   This policy will apply to all services performed on or after the above revision date which will become the new effective date.

B)   For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

 

1)    Transcatheter pulmonary valve implantation requires preauthorization.

2)    This procedure is an alternative to open heart surgery in patients with previous repair of congenital heart disease and right ventricular outflow tract obstruction.
Medical Statement

1)    QualChoice considers Transcatheter pulmonary valve implantation using FDA-approved devices (e.g., Melody Transcatheter Pulmonary Valve) medically necessary in patients with prior repair of congenital heart disease  (Z87.74) for the treatment of dysfunctional right ventricular outflow tract (RVOT) conduits whose pulmonary valve has become stenotic (mean RVOT gradient greater than or equal to 35 mm Hg) or regurgitant (moderate or more severe regurgitation), where individuals indicated for the procedure have a full circumferential RVOT conduit greater than or equal to 16 mm in diameter when originally implanted.

2)    Any other use of TPVI is considered experimental and investigational, and is not covered.

 

 

Codes Used in This BI:

 

0262T   Implantation of catheter-delivered prosthetic pulmonary valve, endovascular

            approach. (deleted 1-1-16)

33477   Transcatheter pulmonary valve implantation, percutaneous approach
Limits
Intentially left empty
Reference

Eiken A, Ewert P, Hager A, Peters B, Fratz S, Kuehne T, et al. Percutaneous pulmonary valve implantation: two-centre experience with more than 100 patients. Eur Heart J. 2011 May; 32(10):1260-5. Epub 2011 Jan 27.

U.S. Food and Drug Administration Device Approvals and Clearances. Humanitarian Device Approval, Medtronic Melody® Transcatheter Pulmonary Valve - H080002. Available at URL address: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm199258.htm

McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after Transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3; 122(5):507-16. Epub 2010 Jul 19.

National Institute for Health and Clinical Excellence. Interventional procedure guidance 266. Transcatheter aortic valve implantation for aortic stenosis. UK: NICE; 2008 Jun.

Zahn EM, Hellenbrand WE, Lock JE et al. (2009) Implantation of the Melody Transcatheter pulmonary valve in patients with a dysfunctional right ventricular outflow tract conduit. J Am Coll Cardiol 2009; 54(18):1722-9.

 
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.