Clinical Coverage Guideline page 1 Easy Choice Health Plan, Inc.
Harmony Health Plan of Illinois, Inc.
Missouri Care, Inc.
‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc.
WellCare Health Insurance of Illinois, Inc.
WellCare Health Plans of New Jersey, Inc.
WellCare Health Insurance of Arizona, Inc.
WellCare of Florida, Inc.
WellCare of Connecticut, Inc.
WellCare of Georgia, Inc.
WellCare of Kentucky, Inc.
WellCare of Louisiana, Inc.
WellCare of New York, Inc.
WellCare of South Carolina, Inc.
WellCare of Texas, Inc.
WellCare Prescription Insurance, Inc.
Windsor Health Plan
Windsor Rx Medicare Prescription Drug Plan
Transcatheter Cardiac Procedures
Policy Number: HS-249
Original Effective Date: 5/1/2014 Revised Date(s): 4/2/2015APPLICATION STATEMENT
The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.
DISCLAIMER
The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.
BACKGROUND
Transcatheter aortic valve implantation (TAVI) (or Transcatheter Aortic Valve Replacement [TAVR]) is a nonsurgical treatment for severe aortic stenosis. This procedure involves delivering and implanting a bioprosthetic valve via a peripheral artery.
Percutaneous Pulmonary Valve Implantation (PPVI) devices may extend the life span of members with failing prosthetic pulmonary conduits and congenital heart defects. PPVI is not expected to replace the initial open heart surgery for placement of a pulmonary conduit, but it is expected to reduce the total number of open heart right ventricular outflow tract (RVOT) procedures over a patient’s lifetime.1
Transcatheter mitral valve repair (TMVR) is an option for members that are not favorable candidates for surgical repair in the treatment of mitral regurgitation.2 While some companies are developing catheter-based devices (e.g., Abbott Vascular’s MitraClip Mitral Valve Repair System) for the treatment of mitral valve disorders, the FDA has not issued any approvals.
Professional Organizations
The United States Food and Drug Administration (FDA) classifies transcatheter aortic valve implantation (TAVI) devices as Class III under the designation “aortic valve, prosthesis, percutaneously delivered” (PMA product code NPT). Of the 2 TAVI devices used in the United States, only 1 has received marketing approval. The Edwards SAPIEN Transcatheter Heart Valve (Edwards Lifesciences LLC) was approved on November 2, 2011, for
transfemoral delivery in patients with severe symptomatic native aortic valve stenosis. The SAPIEN Transcatheter Heart Valve is indicated for patients with severe symptomatic native aortic valve stenosis, who have been
determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing
comorbidities would not preclude the expected benefit from correction of the aortic stenosis. The SAPIEN valve is available in 2 sizes: 23 and 26 millimeters (mm).
The FDA Advisory Panel approved a Premarket Approval Application on October 19, 2012, for the SAPIEN valve, using both the transfemoral and transapical routes of delivery, for patients with severe, symptomatic aortic stenosis who are a high surgical risk. The other TAVI device used in the United States, CoreValve System (Medtronic Inc.), received approval for its Investigational Device Exemption application on October 15, 2010 (Medtronic Inc., 2010).
The CoreValve System has been approved for use in Europe since 2007 (Medtronic Inc., 2011). Recently,
Medtronic received approval for an extended investigation of CoreValve under the FDA’s Continued Access Policy to continue enrolling extreme risk patients.3,4
The American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), American Association of Thoracic Surgeons (AATS), and Society for Cardiovascular Angiography and Interventions (SCAI) released an expert consensus document to provide important guidance on the use of TAVI.5,6 The consensus document outlines key recommendations for the successful employment of TAVI, including:
Careful patient selection.
Team-based approach given the complexity of TAVI coupled with the high-risk profile of suitable patients, many of whom have extensive comorbid conditions that require ongoing management.
Specialized heart centers and physicians with expertise in treating valve disorders; this includes use of
Clinical Coverage Guideline page 3 proctors as needed to serve on the heart care team during the first few cases, as well as proper facilities (hybrid operating rooms or modified catheterization laboratories).
TAVI screening tests to inform treatment decisions.
Enhanced patient and family education in the risk and benefits of this procedure.
Ongoing evaluation and participation in national TAVI registry to assess real-world outcomes.
The organizations also provided additional expert consensus recommendations for patient selection, screening, and post-procedural care.3,5 TAVR is recommended for members who have:
Severe, symptomatic, calcific stenosis of a tri-leaflet aortic valve;
Aortic and vascular anatomy suitable for TAVR and a predicted survival of 12 months; and
A prohibitive surgical risk as defined by an estimated ≥ 50% risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or
pulmonary disease.
TAVR is a reasonable alternative to SAVR in patients at high surgical risk. Further recommendations include:
Implementation of standardized screening protocols for every TAVI evaluation (e.g., metrics to calculate STS score, comorbid conditions, cognitive impairment, imaging data, arterial mapping);
Expertise of team (> 50 SAVR surgeries in past year, experience with balloon aortic valvuloplasty, proctored experience with all device approaches);
Setting (cardiac catheterization laboratories or hybrid room)
Proper postprocedural care and rehabilitation; and
Participation in national registries.
POSITION STATEMENT
Applicable To:
Medicaid Medicare
Transcatheter aortic valve implantation (TAVI) or transcatheter aortic heart valve replacement (TAVR) is considered medically necessary and a covered benefit with devices that have received U.S. Food and Drug Administration (FDA) approval (e.g., Edwards SAPIEN™ Transcatheter Heart Valve [Edwards Lifesciences, LLC, Irvine, CA]) and when the following are met:
Member has severe symptomatic calcified native aortic valve stenosis without severe aortic insufficiency;
AND,
An ejection fraction of > 20%;
AND either of the following:
EITHER of the following:
Member is deemed inoperable per cardiac team (including a cardiac surgeon and a cardiologist), and existing comorbidities would not impede the expected benefit from correction of the aortic stenosis;
AND/OR,
Member is a candidate for aortic valve replacement however, the predicted Society of Thoracic Surgeons
operative risk score is ≥ 8%, or are deemed by the heart team to have a ≥ 15% risk of mortality for surgical aortic valve replacement.
Transfemoral and transapical delivery approaches to transcatheter aortic heart valve replacement are the only approaches with FDA approval. All other delivery approaches (e.g., subaxillary, subclavian, transaortic) are considered experimental and investigational.
Pediatric and adult members may be eligible using an FDA-approved device (e.g., Medtronic Melody®
Transcatheter Pulmonary Valve) in lieu of surgery when the following are met:1
Existence of a full (circumferential) right ventricular outflow tract (RVOT) conduit that was equal to or greater than 16 mm in diameter when originally implanted; AND,
Dysfunctional RVOT conduit with a clinical indication for intervention; AND, ONE of the following:
Regurgitation is greater than or equal to moderate; OR,
Stenosis: mean RVOT gradient greater than or equal to 35 mmHg.
Alternatives to TAVI include surgical aortic valve replacement (SAVR). Providers should educate the member of the risks and benefits of SAVR.
Exclusions
TAVI is considered experimental and investigational for the following, but is not limited to:
Mitral valve repair
Active infections (e.g., bacterial endocarditis)
Acute myocardial infarction (MI) less than or equal to one month of planned TAVR
Aortic valve stenosis that can be treated by surgical aortic valve replacement
Cannot tolerate anticoagulation or an antiplatelet regimen
Congenital bicuspid or unicuspid aortic valve, or is noncalcified
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Hypertrophic cardiomyopathy with or without obstruction
Life expectancy of less than or equal to 12 months due to noncardiac comorbid conditions
Magnetic Resonance Imaging (MRI) confirmed cerebral vascular accident (CVA) or transient ischemic attack (TIA) within six months of planned TAVR
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation greater than 3+)
Renal insufficiency (creatinine greater than 3.0 mg/dL) and/or end-stage renal disease requiring chronic dialysis
Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) less than or equal to 20 percent
Severe mitral regurgitation
Severe pulmonary hypertension and right ventricular dysfunction
Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter five cm or greater, marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [greater than five mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta;6 OR
Transapical, transventricular, or any approach other than transfemoral.
All other indications not listed above.
Clinical Coverage Guideline page 5 In addition, the following devices are considered experimental and investigational:
CoreValve transcatheter device
JenaValveTM transapical transcatheter device
Leaflet repair (e.g., MitraClip®)7
Percutaneous annuloplasty (e.g., Carillon® Mitral Contour System™)8 CODING
CPT© Codes
33361 Transcatheter aortic valve replacement (TAVR/TAVI)w/ 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 33364 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach 33365 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median Sternotomy, mediastinotomy)
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 (eg, femoral vessels)
33368 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with open peripheral arterial and venous cannulation (eg, femoral, iliac, axillary vessels) 33369 Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; cardiopulmonary bypass support with central arterial and venous cannulation (eg, aorta, right atrium, pulmonary artery) 37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretations,
intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (e.g., congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles)
0262T Implantation of catheter-delivered prosthetic pulmonary valve, endovascular approach
ICD-9 Procedure
35.05 Endovascular replacement of aortic valve 35.06 Transapical replacement of aortic valve 35.07 Endovascular replacement of pulmonary valve 35.08 Transapical replacement of pulmonary valve
HCPCS®* Codes – No applicable codes.
Covered ICD-9-CM Diagnosis Codes 424.1 Aortic valve disorders
396.0 Mitral valve stenosis and aortic valve stenosis 396.1 Mitral valve stenosis and aortic valve insufficiency 396.2 Mitral valve insufficiency and aortic valve stenosis 396.3 Mitral valve insufficiency and aortic valve insufficiency 396.8 Mutliple involvement of mitral and aortic valves 396.9 Mitral and aortic valve diseases, unspecified
Covered Draft 2014 ICD-10-CM Diagnosis Codes I08.0 Rheumatic disorders of both mitral and aortic valves I08.8 Other rheumatic multiple valve diseases
I08.9 Rheumatic multiple valve disease, unspecified
I35.0 Nonrheumatic aortic (valve) stenosis I35.1 Nonrheumatic aortic (valve) insufficiency
I35.2 Nonrheumatic aortic (valve) stenosis with insufficiency I35.8 Other nonrheumatic aortic valve disorders
I35.9 Nonrheumatic aortic valve disorder, unspecified
*Current Procedural Terminology (CPT®) 2015 American Medical Association: Chicago, IL.
REFERENCES
1. Melody transcatheter pulmonary valve (Medtronic, Inc.). Hayes Directory Web site. http://www.hayesinc.com. Published July 31, 2013 (archived August 31, 2014). Accessed March 26, 2015
2. Health technology forecast: transcatheter mitral valve repair for treating mitral regurgitation. ECRI Institute Web site. https://www.ecri.org.
Published 2013. Accessed March 26, 2015.
3. Transcatheter aortic valve implantation for aortic stenosis. Hayes Directory Web site. http://www.hayesinc.com. Published October 21, 2013 (updated June 26, 2014). Accessed March 26, 2015.
4. Health technology forecast news brief: FDA panel supports expanded indication of TAVI device. ECRI Institute Web site.
https://www.ecri.org. Published 2012. Accessed March 26, 2015.
5. Holmes DR, Mack MJ, Kaul S, et al. ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement:
developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio- Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance. Catheterization and Cardiovascular Interventions.
2012;79(7):1023-1082.
6. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. American Association for Thoracic Surgery Web site. http://www.aats.org. Published 2012. Accessed March 26, 2015.
7. MitraClip mitral valve repair system (Abbott Vascular). Hayes Directory Web site. http://www.hayesinc.com. Published March 25, 2013 (archived April 25, 2014). Accessed March 26, 2015.
8. Percutaneous mitral valve repair. Hayes Directory Web site. http://www.hayesinc.com. Published February 20, 2014 (updated February 25, 2015). Accessed March 26, 2015.
9. Centers for Medicare and Medicaid Services Web site. National coverage determination for transcatheter aortic valve replacement (TAVR) (20.32). http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx. Published 2013. Accessed March 26, 2015.
MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS
Date Action
4/2/2015 Approved by MPC. No changes.
5/1/2014 Approved by MPC. New.
