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Date Printed: June 23, 2017: 11:39 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-33000-33

Original Effective Date: 08/15/13

Reviewed: 07/24/14

Revised: 01/01/16

Subject: Transcatheter Pulmonary Valve Implantation

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates   Previous Version
           

DESCRIPTION:

Transcatheter pulmonary valve implantation (TPVI) is an alternative to pulmonary valve replacement by open surgery. It is intended for patients who have previously had a pulmonary valve repair for congenital heart disease, in whom dysfunction of the repaired valve necessitates further intervention.

Transcatheter pulmonary valve replacement offers a potentially less invasive treatment option for patients with prior surgery for congenital heart disease and right ventricular outflow tract (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.

The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System are used together for percutaneous replacement of a dysfunctional pulmonary valve. The procedure is performed on the beating heart without use of cardiopulmonary bypass. The Melody valve is first crimped to fit into the Ensemble Transcatheter Valve 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. An inner balloon is inflated to open up the artificial valve, and then an outer balloon is inflated to position the valve into place.

The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System, manufactured by Medtronic Heart Valves, Inc (Santa Ana, CA), received U.S. Food and Drug Administration (FDA) approval under the Humanitarian Device Exemption (HDE) Program on January 25, 2010.

POSITION STATEMENT:

Transcatheter pulmonary valve implantation (TPVI) meets the definition of medical necessity 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:

• High-risk for surgery due to concomitant medical comorbidities; OR

• Poor surgical candidate due to multiple prior thoracotomies for open heart surgery.

The Melody transcatheter pulmonary valve and the Ensemble Transcatheter Valve Delivery System is considered medically necessary as an adjunct to surgery in the management of pediatric and adult patients with the following clinical conditions:

1. Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, AND

2. Dysfunctional RVOT conduits with clinical indication for intervention, and either:

a. Regurgitation: >moderate regurgitation, OR

b. Stenosis: mean RVOT gradient >35 mm Hg

Transcatheter pulmonary valve implantation is considered experimental or investigational for all other indications. There is insufficient clinical evidence published in the peer-reviewed literature on the off-label use of TPVI, including implantation of a non FDA-approved valve, or use of an approved valve for a non FDA-approved indication.

BILLING/CODING INFORMATION:

The following code may be used to describe transcatheter pulmonary valve implantation.

CPT Coding

33477

Transcatheter pulmonary valve implantation, percutaneous approach, including pre-stenting of the valve delivery site, when performed

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

I97.0; I97.110; I97.130 and I97.190

Intraoperative and postprocedural complications and disorders of circulatory system, not elsewhere classified – post-cardiac surgery code list

Q20.5

Corrected transposition of great vessels

Q21.3

Tetralogy of Fallot

Q22.0 – Q22.3

Congenital malformations of pulmonary valves, code list

T82.01xA – 782.09xS

Mechanical complication of heart valve prosthesis, code range

T82.221A – 782.228S

Mechanical complication of biological heart valve graft, code range

Z95.2 – Z95.4

Presence of heart valve, code range

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products: The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services L29288 located at fcso.com.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Transcatheter Aortic Valve Replacement, 02-33000-32

OTHER:

Other terms used to describe transcatheter pulmonary valve implantation:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

CoreValve™ System (aortic valve)

Edwards SAPIEN® transcatheter heart valve (aortic valve)

Medtronic Melody (pulmonary valve)

Percutaneous pulmonary valve implantation (PPVI)

Transcatheter pulmonary valve replacement (TPVR)

REFERENCES:

  1. Blue Cross Blue Shield Association Medical Policy Reference Manual 7.01.131 Transcatheter Pulmonary Valve Implantation (11/13/14).
  2. ECRI. Product Brief: Melody Transcatheter Pulmonary Valve (Medtronic, Inc.) for Repairing Regurgitant or Stenotic Right Ventricular Outflow Tract Conduit (05/2012).
  3. ECRI. Emerging Technology Evidence Report. Percutaneous Pulmonary Valve Implantation for Treating Right Ventricular Outflow Tract Dysfunction (May 2011).
  4. Gillespie MJ, Rome JJ, Levi DS, Williams RJ, Rhodes JF, Cheatham JP, Hellenbrand WE, Jones TK, Vincent JA, Zahn EM, McElhinney DB. Melody valve implant within failed bioprosthetic valves in the pulmonary position: a multicenter experience. Circ Cardiovasc Interv. 2012 Dec;5(6):862-70.
  5. Hasan BS, McElhinney DB, Brown DW, Cheatham JP, Vincent JA, Hellenbrand WE, Jones TK, Zahn EM, Lock JE. Short-term performance of the transcatheter Melody valve in high-pressure hemodynamic environments in the pulmonary and systemic circulations. Circ Cardiovasc Interv. 2011 Dec 1;4(6):615-20.
  6. McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14.
  7. 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.
  8. National Guideline Clearinghouse. Guideline Summary. Recommendations for delivery of care and ensuring access. In: ACC/AHA 2008 guidelines for the management of adults with congenital heart disease. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Accessed 06/12/13.
  9. National Institute for Health and Clinical Excellence (NICE) Interventional Procedure Guidance 436. Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction. January, 2013.
  10. Thyregod HG, Søndergaard L, Ihlemann N, Franzen O, Andersen LW, Hansen PB, Olsen PS, Nissen H, Winkel P, Gluud C, Steinbrüchel DA. The Nordic aortic valve intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial. Trials. 2013 Jan 9;14:11.
  11. Warnes CA, Williams RG, Bashore TM, Child JS, Connolly HM, Dearani JA, del Nido P, Fasules JW, Graham TP, Hijazi ZM, Hunt SA, King ME, Landzberg MJ, Miner PD, Radford MJ, Walsh EP, Webb GD, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CD, Creager MA, Ettinger SM, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura RA, Page RL, Riegel B, Tarkington LG, Yancy CW. Recommendations for delivery of care and ensuring access. In: ACC/AHA 2008 guidelines for the management of adults with congenital heart disease. J Am Coll Cardiol. 2008;52(23):e151-73.
  12. US Food and Drug Administration (FDA) Summary of Safety and Probable Benefit. Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Valve Delivery System. Accessed 06/11/13.
  13. Webb JG, Wood DA, Ye J, Gurvitch R, Masson JB, Rodés-Cabau J, Osten M, Horlick E, Wendler O, Dumont E, Carere RG, Wijesinghe N, Nietlispach F, Johnson M, Thompson CR, Moss R, Leipsic J, Munt B, Lichtenstein SV, Cheung A. Transcatheter valve-in-valve implantation for failed bioprosthetic heart valves. Circulation. 2010 Apr 27;121(16):1848-57.
  14. Zahn EM, Hellenbrand WE, Lock JE, McElhinney DB. Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit Early - Results From the U.S. Clinical Trial. J Am Coll Cardiol 2009;54:1722–9.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 07/24/14.

GUIDELINE UPDATE INFORMATION:

08/15/13

New Medical Coverage Guideline.

08/15/14

Scheduled review; position statement unchanged, references updated.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS code update. Deleted 0262T. Added 33477.

Date Printed: June 23, 2017: 11:39 AM