Ventricular Assist Devices (VADs)
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Defines medical necessity and coding guidance for FDA‑approved ventricular assist devices (including pediatric HDE devices) used as bridge to recovery, bridge to transplant, or destination therapy for members/enrollees of the health plan.
Added code Q0508 to HCPCS coding table.
Relocated contraindication criteria under I.A. to I.B. and removed 'as applicable' from I.A.
Updated substance use contraindication language in criteria I.A.5.
Coverage Criteria for Ventricular Assist Devices
The policy previously included explicit ICD code lists but those lists have been removed from the current document and are no longer authoritative. Code lists in prior versions were intended as informational; their presence or absence does not by itself establish coverage. Inclusion of a diagnosis code on any historical list or in clinical documentation does not guarantee coverage. Coverage is determined by whether the specific clinical criteria in this policy are met and by the member's benefit terms.
For Medicaid members/enrollees, state Medicaid coverage provisions take precedence if they conflict with this clinical policy. Providers must follow the applicable state Medicaid manual and any state-specific rules when there is a discrepancy between this policy and state Medicaid requirements.
A prior version of the policy included a section (Criteria III) stating that requests not meeting the listed criteria were not considered medically necessary; that explicit section has been removed. The practical effect remains: devices or requests that do not satisfy the policy's stated medical necessity criteria are not supported as medically necessary under this policy and are at risk for denial.
Coding and Clinical Thresholds
| 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. |
| 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. |
Provider Responsibilities, Prior Authorization, and Documentation
Obtain prior authorization for listed VAD procedures and HCPCS supplies
Prior authorization is required for VAD procedures and the listed HCPCS supplies/accessories. This includes implantation, removal, replacement, percutaneous insertion/removal procedures and the HCPCS supply codes enumerated in the policy.
- Covered CPT codes include 33975–33983, 33990–33992.
- Covered HCPCS supply/accessory codes include Q0478–Q0489 and Q0508.
Verify Medicare and Medicaid coverage rules before submission
Review Medicare NCDs, LCDs, and Medicare Coverage Articles for Medicare members before applying this policy; for Medicaid members, follow state Medicaid manual provisions when state coverage conflicts with this policy.
- Medicare: review applicable NCDs, LCDs, and Coverage Articles via CMS prior to applying the policy.
- Medicaid: state Medicaid coverage provisions take precedence — refer to the state Medicaid manual.
Document prior optimal medical management (step therapy)
Document prior optimal medical management before requesting destination therapy VAD. Evidence must show trials of guideline-directed therapy (including beta‑blockers and ACE inhibitors, if tolerated) for the required duration.
- No response to optimal medical management (including beta‑blockers and ACE inhibitors, if tolerated) for at least 45 of the last 60 days is required when claiming lack of response.
- Other destination-therapy pathways include balloon pump dependence ≥7 days or IV inotrope dependence ≥14 days, or CI <2.2 L/min/m2 with specified supporting criteria.
Attach explicit provider note summarizing indication and rationale
Include a clear provider note that states the indication, urgency, and that clinical criteria and prior therapies were considered when recommending VAD therapy.
- State the specific indication (bridge to recovery, bridge to transplant, or destination therapy).
- Confirm review of medical therapy trials and physiologic thresholds in the provider note.
- Acknowledge the provider’s professional judgment and that documentation supports medical necessity per the Health Plan.
Provide required clinical documentation to demonstrate indication, prior support, and contraindication status
Submit clinical documentation that demonstrates the specific indication (bridge to recovery, bridge to transplant, or destination therapy), prior respiratory/cardiac support and physiologic measures, and absence of contraindications to support medical necessity.
- Indication detail: bridge to recovery, bridge to transplant, or destination therapy (NYHA Class IV ≥90 days and life expectancy ≤2 years where applicable).
- Physiologic measures: LVEF ≤25%; peak VO2 ≤14 ml/kg/min (unless exceptions apply); cardiac index <2.2 L/min/m2 where applicable.
- Prior support: documentation of balloon pump dependence, IV inotrope dependence, duration of medical management (e.g., 45 of last 60 days).
- Contraindications: document absence of factors such as life expectancy ≤2 years (unrelated to heart disease), recent malignancy, irreversible organ dysfunction, noncompliance/caregiver insufficiency, or active substance use without evidence of risk reduction.
Maintain documentation and exercise professional medical judgment
Providers are responsible for exercising professional medical judgment and for maintaining documentation that supports medical necessity in accordance with the Health Plan and applicable legal/regulatory requirements.
- Documentation must support the clinical decision and compliance with the member’s coverage terms.
- Providers remain responsible for treatment decisions; the policy does not dictate clinical care.
Coverage contingent on meeting all clinical criteria — risk of denial if criteria not met
Coverage is granted only when all medical necessity criteria are met; requests that do not meet the indication, physiologic thresholds, durations of prior therapies, or absence of contraindications risk denial as not medically necessary.
- Key thresholds include LVEF ≤25%, CI <2.2 L/min/m2, peak VO2 ≤14 ml/kg/min (with exceptions), and required durations of prior therapies (e.g., 45 of last 60 days).
- Absence of listed contraindications is required for implantable VAD coverage.
Verify member contract terms and state-specific provisions
Coverage decisions are subject to the member’s contract terms, exclusions, and limitations; when state Medicaid provisions conflict with this policy, state rules govern.
- Verify the member’s contract, exclusions, and limitations prior to authorization determination.
- For Medicaid members, follow the state Medicaid manual where conflicts exist.
Background on Ventricular Assist Devices
Ventricular assist devices (VADs) are mechanical pumps that support systemic circulation when the native heart cannot maintain adequate cardiac output. VAD therapy is used as bridge to recovery, bridge to transplant, or destination therapy. Durable and temporary VADs may improve myocardial function and permit cardiac remodeling during the period of mechanical support; pediatric VAD options and outcomes have expanded as device technology and care strategies have evolved. Some pediatric devices may be available under an FDA Humanitarian Device Exemption/HDE when intended for rare patient populations.
Definitions
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