Download Transcatheter Heart Valves Procedures

REVIEW REQUEST FOR
Transcatheter Heart Valve Procedures
Provider Data Collection Tool Based on Medical Policy SURG.00121
Policy Last Review Date:
02/02/2016
Policy Effective Date: 03/29/2017
Provider Tool Effective Date:
Individual Name:
Date of Birth:
Insurance Identification Number:
Individual Phone Number:
Ordering Provider Name & Specialty:
Provider ID Number:
11/17/2016
Office Address:
Office Phone Number:
Office Fax Number:
Rendering Provider Name & Specialty:
Provider ID Number:
Office Address:
Office Phone Number:
Office Fax Number:
Facility Name:
Facility ID Number:
Facility Address:
Date/Date Range of Service:
Service Requested (CPT if known):
Place of Service:
Outpatient
Home
Inpatient
Other:
Diagnosis Code(s) (if known):
This medical policy based data collection tool is for a medical necessity review request for the transcatheter
(percutaneous or catheter based) approach for aortic or pulmonary heart valve replacement.
Please check all that apply:
Request is for a transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN® , SAPIEN XT™ or
SAPIEN 3 Transcatheter Heart Valve (see section below re: TAVR with Edwards SAPIEN® , SAPIN XT™ or SAPIEN 3
Transcatheter Heart Valve)
Request is for a transcatheter aortic valve replacement (TAVR) with the CoreValue system) (see section below re TAVR
with the CoreValue system)
Request is for a transcatheter aortic valve replacement (TAVR) with other device.
Other device (please list): ____________________________
Request is for transcathether mitral valve repair using leaflet repair (for example: MitraClip Clip Delivery System)
Request is for transcatheter mitral valve repair using percutaneous annuloplasty (for example, CARILLON Mitral Contour
System)
Other (please list):
Request is for TAVR with Edwards SAPIEN® or SAPIEN XT™ or SAPIEN 3 Transcatheter
Heart Valve: (If checked, mark all of the following medical history criteria that apply to the individual)
Individual has a calcified aortic valve
Individual has documented New York Heart Association (NYHA) functional class II or greater
Individual is at intermediate or greater risk for open surgical therapy (that is, predicted risk of surgical mortality equal to or
greater than 3% at 30 days) as determined by at least 2 physicians.
Individual has severe native valve aortic stenosis as demonstrated by (please check all that apply):
Mean aortic valve gradient greater than 40mmHg
Jet velocity greater than 4.0 m/sec
The aortic valve area (AVA) is less than 0.8 cm2
REVIEW REQUEST FOR
Transcatheter Heart Valve Procedures
Provider Data Collection Tool Based on Medical Policy SURG.00121
Policy Last Review Date:
02/02/2017
Policy Effective Date:
03/29/2017
Provider Tool Effective Date:
11/17/2016
The aortic valve area (AVA) index is less than 0.5cm2/m2
Other (please list):
Please check any of the following co-morbid conditions that apply to the individual:
Abdominal aortic or thoracic aneurysm (defined as maximal luminal diameter 5 cm or greater)
Intolerance to anticoagulation/antiplatelet regimen or bleeding dyscrasias (for example. leucopenia, acute anemia
thrombocytopenia
Hypertrophic cardiomyopathy with or without obstruction
Congenital heart valve anomalies including but not limited to congenital unicuspid or bicuspid valve
Active bacterial endocarditis, echocardiographic evidence of intracardiac mass, thrombus or vegetation, or other active
infections
Severe ventricular dysfunction with left ventricular ejection fraction less than or equal to 20 percent
Life expectancy less than 12 months due to non-cardiac co-morbid conditions
Acute myocardial infarction within 1 month of planned procedure
Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within last 6 months
End stage renal disease requiring chronic diaysis
Severe (greater than 3+) mitral regurgitation
Severe (greater than 3+) aortic regurgitation
Pre-existing mechanical prosthetic or transcatheter bioprosthetic heart valve in the aortic position
Iliofemoral vessel would preclude safe placement of 22F or 24F introduction sheath such as severe obstruction
calcification, severe tortuosity or vessel size less than 7mm in diameter (applicable for transfemoral introduction)
Individual was offered surgery but refused
Other treatment (please list):
Request is for TAVR with CoreValue System: (If checked, mark all of the following medical history
criteria that apply to the individual:
The individual has severe degenerative, native valve aortic stenosis demonstrated by:
The aortic valve area (AVA) is equal to or less than 0.8 cm2
The aortic valve index (AVI) is equal to or less than 0.5cm2/m2
A mean aortic valve gradient of more than 40 mm Hg
A peak aortic-jet velocity of more than 4.0 m/sec
The individual has a native aortic annulus diameter between 18 and 29 mm
The individual has heart failure symptoms of New York Heart Association (NYHA) class II or greater
The individual has comorbidities such that at least three physicians agree
(Check all of the following that apply):
The predicted risk of operative mortality at 30 days is 15% or greater
The predicted risk of operative mortality OR serious, irreversible morbidity at 30 days is less than 50%
Please check any of the following co-morbid conditions that apply to the individual:
Intolerance to anticoagulation/antiplatelet regimen or bleeding dyscrasias (for example, leucopenia,
acute anemia, thrombocytopenia; gastrointestinal bleeding within past 3 months);
Hypertrophic obstructive cardiomyopathy
Congenital bicuspid or unicuspid aortic valve
Active bacterial endocarditis, echocardiographic evidence of intracardiac mass, thrombus or vegetations,
or other active infections
Severe ventricular dysfunction with left ventricular ejection fraction less than or equal to 20 percent
Life expectancy less than 12 months due to non-cardiac co- morbid conditions
Acute myocardial infarction within 1 month of planned TAVR procedure;
Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within last 6 months
End stage renal disease requiring chronic dialysis or creatinine clearance less than 20cc/min
Mixed aortic valve disease (aortic stenosis and aortic regurgitation with severity [3-4+])
Moderate to severe (3-4+) mitral regurgitation;
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REVIEW REQUEST FOR
Transcatheter Heart Valve Procedures
Provider Data Collection Tool Based on Medical Policy SURG.00121
Policy Last Review Date:
02/02/2017
Policy Effective Date:
03/29/2017
Provider Tool Effective Date:
11/17/2016
Moderate to severe mitral stenosis
Severe (4+) tricuspid regurgitation
Pre-existing mechanical prosthetic or transcather bioprosthetic heart valve in any position
Individual was offered surgery but refused
Request is for other device not specified above. (Please list):
Request is for a transcatheter aortic valve replacement with a U.S. Food and Drug Administration (FDA)-approved
transcatheter heart valve system (SAPIEN XT or CoreValue System) via an approach consistent with the device’s
FDA-approved labeling.
(If checked, mark all of the following medical history criteria that apply to the individual:
Individual has a failed (stenosed and/or insufficient) previous open surgical bioprosthetic aortic valve
(valve-in-valve implantation)
Individual has been identified by the heart team to have high or greater risk for open surgical therapy with a
Society of Thoracic Surgeons operative risk score equal to or greater than 8% or at a 15% or greater risk
of operative mortality at 30 days
Request is for a transcatheter pulmonary valve (TPV) implantation (If checked, mark all of the following medical history
criteria that apply to the individual:
There exists a full (circumferential) right ventricular outflow tract (RVOT) conduit that was equal to or greater
than 16 mm diameter when originally implanted
There are dysfunctional RVOT conduits with the following clinical indication for intervention:
(If checked, please mark all of the following that apply)
Moderate or greater pulmonic regurgitation
Pulmonic stenosis with a mean RVOT gradient greater or equal to 35 mm Hg
Other (please list):
This request is being submitted:
Pre-Claim
Post–Claim. If checked, please attach the claim or indicate the claim number
I confirm that the information entered on this form is accurate and complete based on the records available at the time of this
request. I understand the health plan or its designees may request medical documentation to verify the accuracy of the
information reported on this form.
Name and Title of Provider or Provider Representative Completing
Form and Attestation (Please Print)*
Date
*The attestation fields must be completed by a provider or provider representative in order for the tool to be accepted
Anthem UM Services, Inc., a separate company, is the licensed utilization review agent that performs utilization
management services on behalf of your health benefit plan or the administrator of your health benefit plan.
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