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Date Printed: October 17, 2017: 04:29 PM

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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.

02-33000-32

Original Effective Date: 07/15/12

Reviewed: 09/22/16

Revised: 10/15/16

Subject: Transcatheter Aortic Valve Replacement

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    
           

DESCRIPTION:

Transcatheter aortic valve replacement (TAVR) or implantation (TAVI) is a potential alternative treatment for patients with severe aortic stenosis as an alternative treatment for individuals that are not candidates for surgery due to prohibitive surgical risk or for patients who are at high risk for open valve replacement surgery. The procedure is performed percutaneously, most often through the transfemoral artery approach. It can also be done through the subclavian artery approach and trans-apically using mediastinoscopy. Balloon valvuloplasty is first performed in order to open up the stenotic area. This is followed by passage of a bioprosthetic artificial valve across the natural aortic valve. The artificial valve is initially compressed to allow passage across the native valve and is then expanded and secured to the underlying aortic-valve annulus. The procedure is performed on the beating heart without the need for cardiopulmonary bypass.

The SAPIEN Transcatheter Heart Valve System™ (Edwards LifeSciences, Irvine, CA) received original FDA approval in November 2011 for patients with severe aortic stenosis who are not eligible for open-heart procedures and have a calcified aortic annulus. In 2012, an additional FDA premarket approval (PMA) was granted for the Edwards SAPIEN™ transcatheter heart valve Model 9000TFX (Edwards LifeSciences, Irvine, CA) with expanded indications for use; approval was granted for both the transfemoral and transapical approach. In September 2013, the FDA expanded the indications for the transapical approach to include both inoperable patients and patients who are at high risk for open surgery. September 2013, the SAPIEN Transcatheter Heart Valve System™ received approval for both high risk and inoperable patients when used by either the transapical or transfemoral approach. The Medtronic CoreValve™ System received FDA approval (2014, 2015); the device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis.

POSITION STATEMENT:

Transcatheter aortic valve replacement with an FDA approved transcatheter heart valve system, performed via an approach consistent with the device’s FDA approved labeling meets the definition of medical necessity for members with native valve aortic stenosis when ALL of the following conditions are present:

NOTE: Severe aortic stenosis is defined by ONE OR MORE of the following criteria:

FDA definition of high risk for open surgery:

Transcatheter aortic valve replacement performed with a transcatheter heart valve system with an FDA approved device approved for use for repair of a degenerated bioprosthetic valve meets the definition of medical necessity when ALL of the following conditions are present:

BILLING/CODING INFORMATION:

The following code(s) may be used to describe transcatheter aortic valve replacement.

CPT Coding

33361

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach

33362

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach

33363

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach (investigational)

33364

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach (investigational)

33365

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (e.g., median sternotomy, mediastinotomy) (investigational)

33366

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transapical exposure (eg, left thoracotomy)

33367

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with percutaneous peripheral arterial and venous cannulation (e.g., femoral vessels) (List separately in addition to code for primary procedure)

33368

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (e.g., femoral, iliac, axillary vessels) (List separately in addition to code for primary procedure) (investigational)

33369

Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (e.g., aorta, right atrium, pulmonary artery) (List separately in addition to code for primary procedure) (investigational)

LOINC Codes:

Documentation Table

LOINC Codes

LOINC Time Frame Modifier Code

LOINC Time Frame Modifier Codes Narrative

Physician history and physical

28626-0

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

Attending physician progress note

18741-9

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Plan of treatment

18776-5

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim.

Laboratory studies

26436-6

18805-2

Include all data of the selected type that represents observations made six months or fewer before starting date of service for the claim

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 National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Transcatheter Aortic Valve Replacement (TAVR) (20.32) located at cms.gov.

DEFINITIONS

Aortic stenosis: a narrowing of the aortic valve opening, resulting in obstruction of blood flow from the left ventricle into the ascending aorta. Treatment of aortic stenosis is primarily surgical, involving replacement of the diseased valve with a bio-prosthetic or mechanical valve by open heart surgery.

Balloon valvuloplasty: a procedure in which a narrowed heart valve is stretched open using a procedure that does not require open heart surgery.

Mediastinoscopy: a surgical procedure that allows physicians to view areas of the mediastinum, the cavity behind the breastbone that lies between the lungs. The organs in the mediastinum include the heart and its vessels, the lymph nodes, trachea, esophagus, and thymus.

New York Heart Association (NYHA) Functional Classification of heart failure symptoms: A classification for the extent of heart failure. Places patients in one of four categories based on the patient’s physical activity limitations. These limitations/symptoms are relevant to normal breathing and varying degrees in shortness of breath and or angina pain:

NYHA Class

 

I

No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

II

Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

III

Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

IV

Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.  If any physical activity is undertaken, discomfort increases.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report transcatheter aortic valve replacement:

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.

Acurata TA (Symetis)
CoreValve (Medtronic)
Engager (Medtronic)
JenaValve (JenaValve Technology)
Nordic valve
Portico (St. Jude Medical)

REFERENCES:

  1. 2008 Focused Update Incorporated into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease). Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol 2008 Sep 23; 52(13):e1-142.
  2. Agency for Healthcare Research and Quality (AHRQ)/National Guideline Clearinghouse; Agency News and Notes, Research Activities; Risks, benefits of emerging heart valve replacement technique not fully understood. October 2010, No. 362.
  3. Agency for Healthcare Research and Quality (AHRQ)/National Guideline Clearinghouse; Risks, Benefits of Emerging Heart Valve Replacement Technique Not Fully Understood. Press Release; August 2, 2010.
  4. American Association for Thoracic Surgery (AATS) Website. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement, January 2012.
  5. American Heart Association: Classes of heart failure, 04/06/2015.
  6. Blackstone EH, Suri RM, Rajeswaran J et al. Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy. Circulation 2015; 131(22): 1989-2000.
  7. Blue Cross and Blue Shield Association Medical Policy Reference Manual, 07.01.132 Transcatheter Aortic-Valve Implantation for Aortic Stenosis, 08/16.
  8. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32), 05/01/12.
  9. Centers for Medicare and Medicaid Services (CMS). Proposed Decision Memo for Transcatheter Aortic Valve Replacement (TAVR) (CAG-00430N), 02/11
  10. D'Onofrio A, Alfieri OR, Cioni M, Alamanni F, Fusari M, Tarzia V, Rizzoli G, Gerosa G. The impact of transcatheter aortic valve implantation on patients' profiles and outcomes of aortic valve surgery programmes: a multi-institutional appraisal. Interact Cardiovasc Thorac Surg. 2013 May; 16(5):608-11.
  11. ECRI Emerging Technology Report – Transcatheter Aortic Valve Implantation Using the SAPIEN Valve for Treating Severe Aortic Valve Stenosis, 02/25/14.
  12. ECRI Health Technology Forecast. FDA grants early approval to Medtronic’s CoreValve TAVI device, 01/31/14.
  13. ECRI Health Technology Forecast. Professional cardiac societies to study expanded indications for TAVI procedure, 02/15/13.
  14. ECRI Health Technology Forecast. Transcatheter Aortic Valve Implantation for Treating Aortic Stenosis, 11/13.
  15. ECRI Health Technology Forecast. Transcatheter aortic valve replacement (TAVR) for treating severe aortic valve stenosis, 02/27/12.
  16. ECRI Health Technology Trends. Opinions differ on growth of transcatheter aortic valve implantation programs in U.S. hospitals, 10/01/12.
  17. ECRI Health Technology Trends. TAVI versus surgical aortic valve implant: PARTNER Cohort A data, 06/01/11.
  18. ECRI Health Technology Trends. Transcatheter aortic valve implantation: the dollars and ‘sense’ of investing in a program, 11/01/12.
  19. ECRI Health Technology Trends. Transcatheter aortic valve replacement is transforming treatment of heart valve disease, 01/01/12.
  20. ECRI Health Technology Trends. Transcatheter aortic valve replacement: The basics, 01/01/12.
  21. ECRI Health Technology Trends. Trials suggest catheter-based valve replacement may reduce mortality and increase quality of life, 01/01/12.
  22. ECRI Product Brief – ACURATE TA (Symetis, Inc.) for Transcatheter Aortic Valve Implantation to Treat Severe Aortic Stenosis, 01/02/14.
  23. ECRI Product Brief – CoreValve Transcatheter Aortic Valve Platform (Medtronic, Inc.) for Treating Severe Aortic Stenosis, 02/03/14.
  24. ECRI Product Brief – Engager Transcatheter Aortic Valve Implantation System (Medtronic, Inc.) to Treat Severe Aortic Stenosis, 02/03/14.
  25. ECRI Product Brief – JenaValve (JenaValve Technology, Inc.) for Transcatheter Aortic Valve Implantation to Treat Severe Aortic Stenosis, 07/08/13.
  26. ECRI Technology Forecast News Brief. Cases of late-occurring thrombotic events from TAVI procedure reported in journal, 02/04/13.
  27. ECRI Technology Forecast News Brief. FDA panel supports expanded indication of TAVI device, 06/22/12.
  28. ECRI Technology Forecast News Brief. TAVI not for everyone with aortic stenosis, researchers caution, 06/01/12.
  29. ECRI Technology Forecast News Brief. Transcatheter Aortic Valve Replacement for Treating Aortic Stenosis, 12/04/12.
  30. Gilard M, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med. 2012 May 3; 366(18):1705-15.
  31. Hemmann K, et al. The STS score is the strongest predictor of long-term survival following transcatheter aortic valve implantation, whereas access route (transapical versus transfemoral) has no predictive value beyond the periprocedural phase. Interact Cardiovasc Thorac Surg. 2013 Aug; 17(2):359-64.
  32. Holmes DR, Jr., Mack MJ. Transcatheter valve therapy; a professional society overview from the American College of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol 2011; 58(4):445-55.
  33. Holmes DR Jr, Mack MJ, Kaul S et al. 2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2012 Mar 27; 59(13):1200-54.
  34. Jegaden O, Lapeze J, Farhart F, de Gevigney G. Aortic valve stenosis after previous coronary bypass: transcatheter valve implantation or aortic valve replacement? J Cardiothorac Surg. 2012 May 29; 7:47.
  35. Kapadia SR, Tuzcu EM, Makkar RR et al. Long-term outcomes of inoperable patients with aortic stenosis randomly assigned to transcatheter aortic valve replacement or standard therapy. Circulation 2014; 130(17): 1483-1492
  36. Kodali SK, et al. Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med, 03/26/12 [PARTNER trial].
  37. Makkar RR, et al. Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis. N Engl J Med, 03/26/12.
  38. Linke A, Wenaweser P, Gerckens U et al. Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study. European Heart Journal 2014; 35(38): 2672-2684.
  39. Ludman PF, Moat N, deBelder MA et al. Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012. Circulation 2015; 131(13): 1181-1205.
  40. Meredith IT, Walton A, Walters DL, et al. Mid-term outcomes in patients following transcatheter aortic valve implantation in the CoreValve Australia and New Zealand Study. Heart Lung Circ. Mar 2015; 24(3):281-290.
  41. Muneretto C, Bisleri G, Moggi A et al. Treating the patients in the 'grey-zone' with aortic valve disease: a comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. Interactive Cardiovascular and Thoracic Surgery 2015; 20(1): 90-95.
  42. National Institute for Health and Clinical Excellence (NICE) interventional procedure guidance 421. Transcatheter aortic valve implantation for aortic stenosis. March 2012.
  43. Osnabrugge RL, Arnold SV, Reynolds MR et al. Health status after transcatheter aortic valve replacement in patients at extreme surgical risk: results from the CoreValve U.S. trial. JACC Cardiovascular Intervention 2015; 8(2): 315-323.
  44. Smith CR, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9; 364(23):2187-98.
  45. Pilgrim T, et al. Predictors of clinical outcomes in patients with severe aortic stenosis undergoing TAVI: a multistate analysis. Circ Cardiovasc Interv. 2012 Dec; 5(6):856-61.
  46. Prabhu W, Gordon PC. Transcatheter aortic valve replacement: a review of current indications and outcomes. Interact Cardiovasc Thorac Surg. 2013 Aug; 17(2):359-64.
  47. Schymik G, Wurth A, Bramlage P et al. Long-term results of transapical versus transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic stenosis. Circulation Cardiovascular Intervention 2014; 8(1):e000761.
  48. Svensson LG, et al. Aortic valve and ascending aorta guidelines for management and quality measures. Ann Thorac Surg. 2013 Jun; 95(6 Suppl):S1-66.
  49. US Food and Drug Administration (FDA). FDA approves first artificial aortic heart valve placed without open-heart surgery, FDA News Release, Nov 02, 2011.
  50. US Food and Drug Administration. Summary of Safety and Effectiveness for the Edwards SAPIEN Transcatheter Heart Valve (PMA P11021). 2012.
  51. US Food and Drug Administration. Summary of Safety and Effectiveness Data: Medtronic CoreValve™ System (MCS) P130021/S010, 03/30/15.
  52. Walther T, Simon P, Dewey T, et al. Transapical Minimally Invasive Aortic Valve Implantation. Multicenter Experience. Circulation. 2007; 116[suppl I]: I-240–I-245.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/22/16.

GUIDELINE UPDATE INFORMATION:

07/15/12

New Medical Coverage Guideline.

01/15/13

Annual CPT/HCPCS coding update; added 0318T, 33361-33369; deleted 0276T-0279T.

04/15/13

Revision of Position Statement; references updated; formatting changes; Program Exceptions section updated.

01/01/14

Annual CPT/HCPCS coding update; added 33366 and deleted 0318T.

04/15/14

Annual review; Position Statement reformatted; additional reformatting; references updated.

12/15/15

Revision; added Medtronic CoreVale device to description and “with an FDA approved device” to position statement. Updated and reformatted references.

10/15/16

Revision; Revised position statement for transcatheter aortic valve replacement for aortic stenosis. Added position statement for transcatheter aortic valve replacement for repair of a degenerated bioprosthetic valve. Deleted transcatheter aortic valve replacement experimental or investigational indications. Upated New York Heart Association (NYHA) functional classification of heart failure symptoms.

Date Printed: October 17, 2017: 04:29 PM