CurrentmhnPolicy CP.MP.46

Ventricular Assist Devices

Policy governing medical necessity and coding for FDA‑approved ventricular assist devices (VADs), including pediatric HDE devices, for members/enrollees of Centene‑affiliated health plans.

Policy Summary

Payermhn

PolicyVentricular Assist Devices

Policy CodePolicy CP.MP.46

Change TypeCriteria update + coding addition

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation supporting indication, LVEF, duration/response to medical management, and device‑specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added Cardiac Index (CI) <2.2 L/min/m2 criteria and related subcriteria for destination therapy eligibility.

Added code Q0508 to HCPCS coding table.

Relocated contraindication criteria under I.B. and removed 'as applicable' from I.A.

I.Primary medical necessity section

II.Pediatric criteria section

33975-33992CPT procedure codes

Q0478-Q0508HCPCS supply codes

2022AHA/ACC/HFSA guideline year

Policy Summary

Payermhn

PolicyVentricular Assist Devices

Policy CodePolicy CP.MP.46

Change TypeCriteria update + coding addition

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation supporting indication, LVEF, duration/response to medical management, and device‑specific criteria.

SourceLink

On This Page

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Medical Necessity and Coverage Criteria

Medical Necessity Criteria (Adults)

Covered when ALL of the following are met:

I.A Indication: Has one of the following indications: (1) Short-term mechanical circulatory support as bridge to recovery for myocardial infarction with cardiogenic shock; high-risk percutaneous coronary interventions; fulminant myocarditis presenting with cardiogenic shock; or advanced heart failure with cardiogenic shock as a bridge-to-a-bridge; (2) Bridge to transplant for members/enrollees awaiting heart transplant (or undergoing evaluation) and not expected to survive until a donor heart is obtained; (3) Destination therapy for end-stage heart failure (NYHA Class IV for ≥90 days with life expectancy ≤2 years) and ineligible for transplant due to age or comorbidities

See nested nodes for destination therapy requirements.

I.A.3 Destination therapy additional requirements: When destination therapy is claimed, ALL of the following apply: a) Meets one of: i) No response to optimal medical management (including beta-blockers and ACE inhibitors, if tolerated) for at least 45 of the last 60 days; ii) Balloon pump-dependent for ≥7 days; iii) IV inotrope-dependent for ≥14 days; iv) Cardiac Index (CI) <2.2 L/min/m2 while not on inotropes AND meets at least one of: 1) No response to optimal medical management for ≥45 of the last 60 days; 2) Advanced heart failure ≥14 days with dependence on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for ≥7 days; b) Left ventricular ejection fraction (LVEF) ≤25%; c) Functionally limited with peak oxygen consumption (peak VO2) ≤14 ml/kg/min unless balloon pump- or inotrope-dependent or physically unable to perform the testLVEF ≤25%; CI <2.2 L/min/m2; peak VO2 ≤14 ml/kg/min

Full nested logic preserved from policy.

I.B Contraindications: For implantable VADs, none of the following contraindications are present: life expectancy in the absence of heart disease ≤ two years; malignancy within five years expected to significantly limit survival; irreversible renal or hepatic dysfunction, severe obstructive pulmonary disease, or other systemic multi-organ disease; a pattern of demonstrated noncompliance or insufficient caregiver support that would place a VAD at serious risk of failure; active substance use or dependence (including current tobacco use, vaping, marijuana use unless prescribed, or IV drug use) without convincing evidence of risk reduction behaviors (serial testing may be used)

Contraindications relocated under I.B per revision.

Pediatric VAD Criteria

Pediatric‑specific VADs are medically necessary when ALL of the following are met:

II.A Pediatric criteria: Device is FDA-approved or approved under the FDA Humanitarian Device Exemption (HDE) and used per device-specific inclusion/exclusion criteria and body size recommendations; Age ≤16 years or age per FDA approved guidelines; severe isolated left ventricular or biventricular dysfunction; used as a bridge to heart transplant for members/enrollees who require circulatory supportAge ≤16 years or age per device labeling

HDE/HUD use requires institutional IRB oversight per FDA guidance.

Administrative edits to this policy removed a previously explicit clause stating that requests which do not meet the stated criteria are not considered medically necessary. This change is administrative in nature and does not alter the substantive medical necessity requirements or clinical thresholds described elsewhere in the policy. Revision history documents the removal of that clause and other wording/organization updates while preserving the clinical criteria and intent.

State Medicaid program coverage provisions take precedence when they conflict with this clinical policy. Providers should refer to the applicable state Medicaid manual or plan-specific guidance for definitive coverage determinations for Medicaid enrollees, and recognize that this clinical policy is a guide to medical necessity rather than a contract or guarantee of payment.

Requests that do not meet the policy’s specified indications, numeric thresholds (for example, LVEF ≤ 25%, Cardiac Index < 2.2 L/min/m2, peak VO2 ≤ 14 ml/kg/min), duration-of-treatment requirements for destination therapy, device‑specific pediatric criteria, or that have listed contraindications are not supported as medically necessary under this policy. This statement summarizes the operational effect of the criteria: documentation must demonstrate that all applicable indications and thresholds are met to support authorization.

CPT and HCPCS Codes; Key Thresholds

Ventricular Assist Devices CPT CodesCPTCovered

33975	Insertion of ventricular assist device; extracorporeal, single ventricle.
33976	Insertion of ventricular assist device; extracorporeal, biventricular.
33977	Removal of ventricular assist device; extracorporeal, single ventricle.
33978	Removal of ventricular assist device; extracorporeal, biventricular.
33979	Insertion of ventricular assist device, implantable intracorporeal, single ventricle.
33980	Removal of ventricular assist device, implantable intracorporeal, single ventricle.
33981	Replacement of extracorporeal ventricular assist device, single or biventricular, pump(s), single or each pump.
33982	Replacement of ventricular assist devices pump(s); implantable intracorporeal, single ventricle, without cardiopulmonary bypass.
33983	Replacement of ventricular assist devices pump(s); implantable intracorporeal, single ventricle, with cardiopulmonary bypass.
33990	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; left heart, arterial access only.

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Ventricular Assist Devices HCPCS CodesHCPCSCovered

Q0478	Power adapter for use with electric or electric/pneumatic ventricular assist device, vehicle type.
Q0479	Power module for use with electric or electric/pneumatic ventricular assist device, replacement only.
Q0480	Driver for use with pneumatic ventricular assist device, replacement only.
Q0481	Microprocessor control unit for use with electric ventricular assist device, replacement only.
Q0482	Microprocessor control unit for use with electric/pneumatic combination ventricular assist device, replacement only.
Q0483	Monitor/display module for use with electric ventricular assist device, replacement only.
Q0484	Monitor/display module for use with electric or electric/pneumatic ventricular assist device, replacement only.
Q0485	Monitor control cable for use with electric ventricular assist device, replacement only.
Q0486	Monitor control cable for use with electric/pneumatic ventricular assist device, replacement only.
Q0487	Leads (pneumatic/electrical) for use with any type electric/pneumatic ventricular assist device, replacement only.

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inv-08: Left ventricular ejection fraction (LVEF) — threshold value

ThresholdLeft ventricular ejection fraction (LVEF) ≤ 25%

ContextRequired for implantable VADs when used as destination therapy per adult criteria

Supporting noteDocument clinical measurement and date in authorization request

inv-09: Peak oxygen consumption — threshold value

ThresholdPeak oxygen consumption (peak VO2) ≤ 14 ml/kg/min

ExceptionNot required if patient is balloon pump- or inotrope-dependent or physically unable to perform the test

Prior Authorization, Documentation, and Billing Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for VAD procedures and device/supply procurement. Submit a completed prior authorization request with supporting clinical documentation demonstrating the indication and medical necessity per policy criteria. Failure to obtain prior authorization when required may result in denial of benefits.

Include procedure codes and device model where applicable
Attach recent cardiac testing (LVEF, CI, peak VO2) and documentation of response to medical therapy

Note

Coverage Subject to Plan Terms and Administrative Rules

Coverage decisions are subject to the terms, conditions, exclusions and limitations of the member's benefit plan, applicable state and federal law, and Health Plan administrative policies. This clinical policy is a guide to medical necessity and does not guarantee payment; verify benefits and plan-level requirements prior to service.

Background and Rationale

A ventricular assist device (VAD) is a mechanical pump used to support circulation when the heart cannot maintain adequate output. VADs are used in three principal clinical roles: as a bridge to recovery for reversible causes of cardiogenic shock (for example, post-infarction or fulminant myocarditis), as a bridge to transplant for patients awaiting donor hearts or undergoing evaluation, and as destination therapy for patients with end-stage heart failure who are not transplant candidates. Clinical benefits can include temporary or durable hemodynamic support, potential myocardial recovery over weeks, and improved functional status when device-specific indications, contraindications, and patient selection criteria are met.

Key Definitions

inv-24: Ventricular assist device (VAD) — definition

DefinitionA ventricular assist device (VAD) is a mechanical pump that helps the heart when it is too weak to pump blood through the body; used short‑term or as durable circulatory support (bridge to recovery, bridge to transplant, or destination therapy)

FunctionEnhances blood flow to organs, either in conjunction with or as a replacement for a damaged heart

Clinical settingsUsed in acute and subacute settings including high‑risk PCI and cardiogenic shock

inv-25: HDE/HUD — Humanitarian Use Device / HDE definition

DefinitionHumanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE): an FDA designation for devices intended to benefit patients with conditions affecting fewer than 8,000 individuals in the U.S. annually

Use requirements

Document Changes and Revision History

11/25annual_reviewLatest

Annual review: relocated contraindication criteria under I.A. to I.B., removed 'as applicable' from I.A., references reviewed and updated; reviewed by internal specialist.

11/24coding_update

Annual review: added HCPCS code Q0508 to the HCPCS coding table.

02/22criteria_update

Added Cardiac Index (CI) <2.2 L/min/m2 with related destination therapy subcriteria to align with CMS NCD update; background updated and references reviewed.