CurrentAmbetter NevadaPolicy CP.MP.46

Ventricular Assist Devices (VADs)

Policy governing medical necessity and coding for FDA-approved ventricular assist devices (including pediatric HDE devices) for members/enrollees of Centene-affiliated health plans (Ambetter Nevada), specifying indications, contraindications, and coding guidance.

Policy Summary

PayerAmbetter Nevada

PolicyVentricular Assist Devices (VADs)

Policy CodePolicy CP.MP.46

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the member meets medical necessity criteria (indication, physiologic thresholds, duration of therapies, and absence of contraindications).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA & HDEdevice types covered

NYHA ≥90ddestination therapy duration

CI <2.2hemodynamic threshold

Q0508HCPCS update

Coverage and Medical Necessity Criteria

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inv-01: Covered Indications (Initial)

FDA-approved VADs are considered medically necessary when meeting the following:

Primary indications: Device used for one of: short-term mechanical circulatory support as bridge to recovery for (a) myocardial infarction with cardiogenic shock; (b) high-risk percutaneous coronary interventions; (c) fulminant myocarditis with cardiogenic shock; or (d) advanced heart failure with cardiogenic shock as a bridge-to-a-bridge; OR bridge to transplant for members awaiting heart transplant or undergoing evaluation and not expected to survive until a donor heart is available; OR destination therapy for end-stage heart failure (NYHA Class IV end-stage left ventricular failure for at least 90 days with life expectancy ≤ 2 years and ineligible for transplant) who meet the additional destination therapy physiologic and temporal criteria below.

Destination therapy specific requirements: Member must have NYHA Class IV end-stage left ventricular failure ≥ 90 days with life expectancy ≤ 2 years and be ineligible for transplant, AND meet one of the following: (i) no response to optimal medical management (including beta-blockers and ACE inhibitors, if tolerated) for ≥ 45 of the last 60 days; (ii) balloon pump-dependent ≥ 7 days; (iii) IV inotrope-dependent ≥ 14 days; (iv) Cardiac Index (CI) < 2.2 L/min/m2 while not on inotropes plus either (1) no response to optimal medical management for ≥ 45 of the last 60 days, OR (2) advanced heart failure for ≥ 14 days with dependence on intra-aortic balloon pump or similar support for ≥ 7 days.LVEF ≤ 25%; VO2 ≤ 14 ml/kg/min unless balloon pump- or inotrope-dependent or unable to perform test

Also requires attempts at optimal medical management (including beta-blocker and ACE inhibitor if tolerated).

Pediatric devices (HDE or FDA approved): Pediatric-specific VADs (FDA-approved or HDE) are medically necessary when used per device-specific inclusion/exclusion criteria including body size; AND age ≤ 16 years or per FDA-approved guidelines; AND severe isolated left ventricular or biventricular dysfunction; AND used as a bridge to heart transplant.

Use of HUD/HDE devices should follow FDA HDE guidance and device labeling (IRB oversight as applicable).

inv-02: Contraindications

Contraindications (presence of any makes implantable VADs not appropriate):

Absolute/relative contraindications: Any of the following contraindications: life expectancy in the absence of heart disease ≤ 2 years; malignancy within 5 years expected to significantly limit survival; irreversible renal or hepatic dysfunction, severe obstructive pulmonary disease, or other systemic multi-organ disease; demonstrated noncompliance or lack of sufficient caregiver support placing 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 (unless urgent transplant timelines exist, where commitment to reduce behaviors may be acceptable).

Serial blood and urine testing may be used to verify abstinence where indicated.

Historically, this policy has been revised multiple times to reflect device availability and coding updates. Earlier revisions removed specific pediatric devices no longer available (e.g., HeartAssist® Pediatric VAD) and removed or replaced certain ICD diagnosis codes; the revision history documents removal of ICD-10 code Z94.1 and addition of Z76.82. In subsequent updates the policy note indicates that ICD diagnosis codes were removed from the document and that prior Criterion III (requests not meeting criteria are not considered medically necessary) was eliminated in a prior revision.

Coverage determinations under this policy are subject to the member's specific benefit plan. The policy is a guide to medical necessity and does not guarantee payment; coverage decisions remain subject to all terms, conditions, exclusions and limitations of the applicable coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract of insurance) and to state and federal requirements.

No additional inventory-specific notes are recorded for this item in the current policy version.

Coding, Clinical Thresholds, and Supply Codes

Covered 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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HCPCS Codes / SuppliesHCPCSCovered

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: Cardiac Index — hemodynamic threshold

Hemodynamic thresholdCardiac Index (CI) < 2.2 L/min/m2 (while not on inotropes)

Contextual requirementIf CI < 2.2 L/min/m2, patient must also meet one of: no response to optimal medical management for ≥45 of last 60 days, or advanced HF ≥14 days with IABP or similar support ≥7 days

Source policy locationPolicy/Criteria I.B.4 (added per NCD Ventricular Assist Devices update)

inv-09: Left ventricular ejection fraction (LVEF)

LVEF thresholdLeft ventricular ejection fraction (LVEF) ≤ 25%

ApplicabilityRequired as part of destination therapy physiologic criteria

Policy sectionCLINICAL POLICY Ventricular Assist Devices — physiologic thresholds

inv-10: Peak oxygen consumption (VO2)

Peak VO2 thresholdPeak oxygen consumption ≤ 14 ml/kg/min

ExceptionsUnless balloon pump- or inotrope-dependent, or physically unable to perform the test

RoleUsed to demonstrate functional limitation when assessing candidacy for VADs

inv-11: Destination therapy NYHA duration — required duration for Class IV

Required duration for NYHA Class IVNYHA Class IV end-stage left ventricular failure for at least 90 days

Associated life expectancy requirementLife expectancy ≤ two years

Transplant eligibilityMember must be ineligible for heart transplant due to age or co-morbidities for destination therapy

inv-12: No response to medical management — timeframe threshold

Medical management failure timeframeNo response to optimal medical management for at least 45 of the last 60 days

IncludesIncludes trials of beta‑blockers and ACE inhibitors if tolerated

ContextOne qualifying pathway for destination therapy candidacy

inv-13: Balloon pump dependency — duration threshold

Balloon pump dependency durationBalloon pump-dependent for ≥ 7 days

Use caseCounts as one pathway to meet destination therapy criteria

Relation to IABPIncludes dependence on intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support for ≥ 7 days

inv-14: IV inotrope dependency — duration threshold

IV inotrope dependency durationIV inotrope-dependent for ≥ 14 days

RoleOne qualifying pathway to meet destination therapy criteria

RequirementDependency must be documented as part of destination therapy physiologic criteria

inv-15: Pediatric age limit — age criteria for pediatric/HDE devices

Pediatric age limitAge ≤ 16 years, or age specific to FDA approved guidelines

Device authorizationApplies to pediatric-specific VADs that are FDA approved or approved under the FDA Humanitarian Device Exemption (HDE)

IndicationUsed as a bridge to heart transplant for pediatric members/enrollees requiring circulatory support

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required for implantation of ventricular assist devices (VADs) and related device supplies. Requests must include clinical documentation demonstrating that the member meets the policy's medical necessity criteria (indication, device-specific and contraindication requirements, pediatric criteria when applicable) and any device FDA labeling/body size recommendations.

Prior authorization requirement applies to implantable and extracorporeal VADs and associated HCPCS supply/accessory codes (see policy coding section).
Submit documentation of indications, prior therapies, hemodynamic data (e.g., Cardiac Index), dependence on inotropes or IABP when applicable, transplant candidacy status, and contraindication assessment.

Note

Medicare Coverage Review Required

For Medicare members/enrollees, providers must review all applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles prior to applying this clinical policy to ensure consistency with Medicare coverage rules.

Refer to the CMS website at http://www.cms.gov for current NCDs, LCDs, and Coverage Articles.
When Medicare rules differ from this policy, Medicare determinations and coverage guidance govern for Medicare members.

Documentation Required

Coding and Documentation

Providers must reference and submit appropriate procedure and supply codes when requesting authorization and when submitting claims. This policy references CPT and HCPCS codes for VAD insertion, removal, replacement, and device supplies and accessories; inclusion or omission of codes in the policy does not guarantee coverage.

Use current CPT codes (e.g., 33975–33983, 33990–33992) for VAD procedures as applicable.
Include relevant HCPCS supply/accessory codes (e.g., Q0478–Q0489, Q0508) for implantable VAD external components and supplies.
Providers should verify and use the most up-to-date professional coding guidance prior to claim submission.

Denial Risk

Denial Risks and Provider Documentation Expectations

This policy does not replace the provider’s responsibility to maintain complete medical records. Coverage decisions are subject to member benefit documents and applicable limits; requests that do not meet the clinical criteria or lack sufficient documentation may be denied.

Denial may result if medical necessity criteria are not met or required documentation is incomplete.
Coverage is subject to the member's contract, evidence of coverage, and state or federal rules that may override this policy.

OpenPayer

Ventricular Assist Devices (VADs)

Coverage and Medical Necessity Criteria

Coding, Clinical Thresholds, and Supply Codes

Provider Requirements, Prior Authorization, and Denial Risks

Background and Context

Key Definitions