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This policy governs medical necessity and prior authorization for ventricular assist devices, percutaneous and right ventricular assist devices, pediatric VADs, total artificial hearts, and related services. Coverage depends on FDA-approved indications, device type, clinical criteria, applicable Medicare or Medicaid guidance, and the member's benefit plan.
Policy Summary
PayerBaylor Scott & White Health Plan
PolicyVentricular Assist Devices and Artificial Heart
Policy CodePolicy 201
Change TypeAdministrative/reference updateno material clinical or coverage change
Effective DateAug 1, 2025
Last ReviewJun 9, 2025
Next Review DateJun 9, 2026
Key ActionObtain prior authorization for ventricular assist devices and artificial heart services.
The policy history records removal of language stating that Medicare NCD- or LCD-specific InterQual criteria may be used when available.
The 2025 update removed the statement that Medicare NCD- or LCD-specific InterQual criteria may be used when available.
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Required
Prior authorization
NYHA IVDestination therapy heart failure class
<25%Destination therapy LVEF
30 daysTemporary RVAD support
No changesPolicy review outcome
Medical Necessity and Coverage Criteria
Medicare LVAD criteria
Medicare coverage applies when the LVAD is FDA approved for short-term or long-term mechanical circulatory support and all of the following are met, including one qualifying clinical-course alternative.
Clinical criteria
Required findings
The patient has New York Heart Association (NYHA) Class IV heart failure.
Left ventricular ejection fraction (LVEF) is ≤25%.≤25%
Hemodynamic support criterion
The patient is inotrope dependent.
The patient is not receiving inotropes and has a cardiac index <2.2 L/min/m2.<2.2 L/min/m2 while not on inotropes
Qualifying clinical course
The patient has received optimal medical management based on current heart failure practice guidelines for at least 45 of the last 60 days and is failing to respond.At least 45 of the last 60 days
The patient has had advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.Advanced heart failure ≥14 days; IABP or similar support ≥7 days
FDA-approved VAD indications
BSWHP may consider a TAC-approved and FDA-approved VAD medically necessary for one or more FDA-approved indications.
Post-cardiotomy
The VAD is FDA approved for post-cardiotomy support of blood circulation and is used according to FDA-approved labeling instructions.
Bridge to transplant
The member is not expected to survive until transplantation, is awaiting heart transplantation, and is listed on the Organ Procurement and Transplantation Network waitlist.
Destination therapy
The device has FDA approval for a destination-therapy indication.
Total artificial heart
A total artificial heart may be considered medically necessary as a bridge to heart transplantation when the patient has biventricular failure, no other reasonable medical or surgical treatment options, and meets one of the following alternatives.
Total artificial heart bridge to transplant
The patient is currently listed as a heart-transplantation candidate.
The patient is undergoing evaluation for heart transplantation and is not expected to survive until a donor heart can be obtained.
Percutaneous VADs
FDA-approved percutaneous VADs may be considered medically necessary for one or more FDA-approved indications.
Percutaneous VAD indications
Impella is used for partial circulatory support with an extracorporeal bypass control unit for a period up to 6 hours.Up to 6 hours
TandemHeart is used for temporary left ventricular bypass for 6 hours or less.6 hours or less
Right ventricular assist devices
An FDA-approved RVAD may be considered medically necessary for temporary circulatory support when all of the following are met.
Temporary RVAD support
The RVAD is used for up to 30 days for a member in cardiogenic shock due to acute right ventricular failure.Up to 30 days
The member is willing and able to be treated with an anticoagulant.
Pediatric VADs
An FDA-approved pediatric VAD may be considered medically necessary when all of the following are met.
Pediatric VAD
The child has documented end-stage left ventricular failure.
An age-appropriate VAD will be used until a donor heart can be obtained.
FDA-approved pediatric devices listed in the policy include the Berlin Heart EXCOR Pediatric VAD for children aged 16 years or younger and the HeartAssist 5 Pediatric VAD for children aged 5 to 16 years. EXCOR may be used in children up to 60 kg; HeartAssist 5 may be used when body surface area is ≥0.7 m2 and <1.5 m2.
Exclusions and unproven services
The following services are not medically necessary under this policy and are considered experimental, investigational, and/or unproven.
Excluded or unproven uses
Use of a VAD for any reason other than the specified medically necessary indications.
Xenotransplantation or heterotransplantation of a baboon heart or porcine/swine heart as a bridge to transplantation.
A ventricular assist device (VAD) used for any reason other than the specified medically necessary indications is considered experimental, investigational, or unproven and is not medically necessary under this policy.
Xenotransplantation or heterotransplantation involving a baboon heart or porcine/swine heart as a bridge to transplantation is considered experimental, investigational, and/or unproven.
Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only
1–10 of 32
1/4
ICD-10 CodesICD-10
I11.0
Hypertensive Heart Disease with CHF
I13.x
Hypertensive Heart and Renal Disease with CHF
I20-I25
Ischemic Heart Diseases
I42.x
Cardiomyopathy
I43.x
Cardiomyopathy in other diseases
I44.x
Atrioventricular and left bundle branch block
I45.x
Other conduction disorders
I48
Atrial fibrillation and flutter
R57.0
Cardiogenic Shock
Medicare LVAD criteria
LVEF threshold≤ 25%
Applicable criteriaMedicare LVAD coverage
Required heart-failure classNYHA Class IV
Medicare LVAD criteria
Cardiac index threshold< 2.2 L/min/m2
ApplicabilityWhile not on inotropes
Alternative clinical status
Authorization, Documentation, and Denial Risks
Prior Authorization
Prior Authorization Required
Prior authorization is required before providing ventricular assist device (VAD) or artificial heart services. Review the member’s Evidence of Coverage or Summary Plan Description for applicable coverage details.
Applies to ventricular assist devices and artificial hearts.
Confirm applicable line-of-business coverage requirements before initiating services.
Documentation Required
Clinical and Device Documentation
Submit complete clinical and device documentation supporting the requested service and the applicable FDA-approved indication. Documentation should establish the diagnosis, severity of heart failure, device approval and labeling, and all applicable medical-necessity criteria.
FDA or Technology Assessment Committee (TAC) approval, as applicable, and use consistent with FDA-approved labeling.
Policy Background
VADs may provide short-term, intermediate, or long-term circulatory support. Depending on the clinical objective, support may serve as a bridge to transplant while a patient awaits transplantation, a bridge to recovery when recovery is anticipated and transplantation is not indicated, or destination therapy when transplantation is not appropriate and adequate cardiac function is not expected to return.
Heart Failure and VAD Therapy Definitions
NYHA functional classification
NYHA Class INo symptoms and no limitation in ordinary physical activity
Example activityWalking or climbing stairs does not ordinarily cause shortness of breath
Functional statusOrdinary physical activity is not limited
NYHA functional classification
NYHA Class IIMild symptoms and slight limitation during ordinary activity
Typical symptomsMild shortness of breath and/or angina
Functional status
Policy Summary
PayerBaylor Scott & White Health Plan
PolicyVentricular Assist Devices and Artificial Heart
Policy CodePolicy 201
Change TypeAdministrative/reference updateno material clinical or coverage change
Effective DateAug 1, 2025
Last ReviewJun 9, 2025
Next Review DateJun 9, 2026
Key ActionObtain prior authorization for ventricular assist devices and artificial heart services.
The member has NYHA Class IV end-stage ventricular heart failure and is not a candidate for heart transplant.
Qualifying treatment history or support dependence
The member has failed to respond to optimal medical management, including beta-blockers and angiotensin-converting enzyme inhibitors if tolerated, for at least 45 of the last 60 days.At least 45 of the last 60 days
The member has been balloon-pump dependent for 7 days.7 days
The member has been dependent on intravenous inotropes for 14 days.14 days
Left ventricular ejection fraction (LVEF) is less than 25%.<25%
The member has demonstrated functional limitation with peak oxygen consumption ≤14 ml/kg/min.≤14 ml/kg/min
This criterion may be waived for persons unable to perform exercise stress testing.
The patient may instead be inotrope dependent
Medicare LVAD criteria
Optimal medical managementAt least 45 of the last 60 days
Treatment basisCurrent heart failure practice guidelines
Response requirementThe patient must be failing to respond
Medicare LVAD criteria
Advanced heart failure durationAt least 14 days
Temporary support durationIABP or similar temporary mechanical circulatory support for at least 7 days
Qualifying courseThis is an alternative to optimal medical management for at least 45 of the last 60 days
Destination therapy
Optimal medical managementAt least 45 of the last 60 days
Included treatmentBeta-blockers and ACE inhibitors if tolerated
Alternative support criteriaBalloon-pump dependence for 7 days or IV inotrope dependence for 14 days
Destination therapy
LVEF threshold< 25%
Therapy contextDestination therapy
Heart-failure classificationNYHA Class IV end-stage ventricular heart failure
Underlying requirementDocumented end-stage left ventricular failure
HeartAssist 5 Pediatric
HeartAssist 5 Pediatric body surface area≥ 0.7 m2 and < 1.5 m2
Listed age rangeChildren aged 5 to 16 years
Treatment purposeUsed until a donor heart can be obtained
Indication and diagnosis, including post-cardiotomy support, bridge to transplant, destination therapy, total artificial heart, percutaneous VAD, RVAD, or pediatric VAD use.
Heart failure severity, including NYHA Class IV status when required, end-stage ventricular failure, and whether failure is left- or right-sided.
Left ventricular ejection fraction (LVEF), cardiac index, inotrope or balloon-pump dependence, optimal medical management history, transplant status, and functional limitation or peak oxygen consumption when applicable.
For total artificial hearts, document biventricular failure and absence of other reasonable medical or surgical treatment options.
For pediatric VADs, document end-stage left ventricular failure, intended bridge to donor heart, age or body-size eligibility, and the specific device.
Documentation Required
Program-Specific Documentation
Apply the program-specific coverage rules before using the policy criteria. Medicare cases should follow the applicable NCD or LCD, including NCD 20.9.1 and its multidisciplinary-team requirements; Medicaid cases should follow the Texas Medicaid Provider Procedures Manual (TMPPM).
For Medicare, use the applicable NCD or LCD; refer to Medicare documents for coverage of other devices and follow multidisciplinary-team requirements.
For Medicaid, confirm coverage and medical-necessity guidance in the Texas Medicaid Provider Procedures Manual (TMPPM).
If no applicable Medicare or Medicaid criteria exist, apply the criteria in this policy.
Denial Risk
Unapproved or Excluded Use
VAD use for a reason other than a specified FDA-approved and medically necessary indication is considered experimental, investigational, or unproven. Xenotransplantation or heterotransplantation involving a baboon or porcine/swine heart is also experimental, investigational, or unproven as a bridge to transplantation.
Confirm the requested device and indication are FDA approved and consistent with labeled use.
Do not assume coverage for an indication not listed in the policy or applicable Medicare or Medicaid guidance.
Baboon-heart and porcine/swine-heart xenotransplantation is excluded as a bridge to transplantation.
Denial Risk
Destination Therapy Criteria Not Met
Destination-therapy requests may be denied when any required criterion is not met. Confirm the device is FDA approved for destination therapy and document NYHA Class IV end-stage ventricular heart failure, lack of transplant candidacy, the required failure of optimal medical management or specified support dependence, LVEF below 25%, and functional limitation.
Device has FDA approval for a destination-therapy indication.
Member has NYHA Class IV end-stage ventricular heart failure and is not a candidate for heart transplant.
Member failed optimal medical management, including beta-blockers and ACE inhibitors if tolerated, for at least 45 of the last 60 days; or was balloon-pump dependent for 7 days; or was IV-inotrope dependent for 14 days.
LVEF is less than 25%.
Peak oxygen consumption is less than or equal to 14 mL/kg/min; this criterion may be waived when the member cannot perform exercise stress testing.
Denial Risk
RVAD Criteria Not Met
RVAD requests may be denied unless the device is being used for temporary support in cardiogenic shock caused by acute right ventricular failure, for no more than 30 days, and the member is willing and able to receive anticoagulant treatment.
Cardiogenic shock is due to acute right ventricular failure.
Temporary RVAD support will not exceed 30 days.
Member is willing and able to be treated with an anticoagulant.
Ordinary activity causes a slight limitation
NYHA functional classification
NYHA Class IIIMarked limitation in activity due to symptoms; comfortable only at rest
Activity limitationSymptoms occur even during less-than-ordinary activity
Example activityWalking short distances of 20–100 m may cause symptoms
NYHA functional classification
NYHA Class IVSevere limitation with symptoms even at rest
Functional statusPatients are mostly bedbound
Symptom occurrenceSymptoms are present while at rest
VAD therapy roles
Bridge to transplantationMaintains circulation until transplantation
Bridge to recoveryUsed when transplantation is not indicated and recovery is anticipated
Destination therapyUsed when the individual is inappropriate for heart transplant and adequate cardiac function is not expected to return