CurrentColorado Rocky Mountain Health PlansPolicy MMP240.16

Percutaneous Ventricular Assist Device

Policy governing percutaneous insertion of endovascular cardiac assist devices (pVAD) for Medicare Advantage members; defines limited life‑threatening indications, references CMS LCDs/LCAs, and lists applicable codes and clinical evidence.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPercutaneous Ventricular Assist Device

Policy CodePolicy MMP240.16

Change TypeNo material change

Effective DateOctober 1, 2025

Next Review DateN/A

Key ActionObtain and document prior authorization and clinical justification showing the patient meets one of the three life‑threatening indications and that IABP is not expected to be sufficient.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3life‑threatening indications

33990–33995CPT codes listed

Higher CI/MAPHemodynamic benefit noted

Bleeding ↑Adverse event risk

Coverage Criteria

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Reasonable and Necessary Coverage Criteria

Covered when ALL of the following are met

Primary coverage conditions: The patient is in one of the following life‑threatening situations: cardiogenic shock; severe decompensated heart failure with threatening multi‑organ failure; or complications/disturbances of the circulatory system intra‑operatively or postoperatively.

Refer to applicable LCDs/LCAs where present.

IABP considered insufficient: External counterpulsation (intra‑aortic balloon pump, IABP) is not expected to be sufficient for the patient.

IABP should be considered first; pVAD reasonable only when IABP is insufficient.

Regulatory adherence: Use of the percutaneous endovascular cardiac assist device adheres strictly to FDA approval guidelines for the device.

Coverage only when FDA approval guidelines are followed.

Use of percutaneous ventricular assist devices (pVAD) outside the specifically defined life‑threatening situations is not considered reasonable and necessary. The policy limits coverage to three circumstances—cardiogenic shock; severe decompensated heart failure with threatening multi‑organ failure; or intraoperative or postoperative circulatory complications/disturbances—and only when intra‑aortic balloon pump (IABP) is not expected to be sufficient and FDA approval guidelines are strictly followed.

Percutaneous left ventricular assist devices are more invasive than IABP and have been associated with higher rates of some adverse events. A meta‑analysis reported improved hemodynamics (higher cardiac index and mean arterial pressure, lower pulmonary capillary wedge pressure) with percutaneous LVADs versus IABP but found similar 30‑day mortality and noted that the TandemHeart was associated with increased bleeding. The analysis concluded that the devices’ higher invasiveness contributed to a higher rate of adverse events, which may limit use in some patients.

Coding

Applicable CPT Procedure CodesCPT

33990	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; left heart arterial access only.
33991	Insertion of ventricular assist device, percutaneous including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture.
33995	Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only

Applicable Diagnosis Codes (ICD-10)ICD-10

I50.1	Left ventricular failure, unspecified.
I50.20	Unspecified systolic (congestive) heart failure.
I50.21	Acute systolic (congestive) heart failure.
I50.22	Chronic systolic (congestive) heart failure.
I50.23	Acute on chronic systolic (congestive) heart failure.
I50.30	Unspecified diastolic (congestive) heart failure.
I50.31	Acute diastolic (congestive) heart failure.
I50.32	Chronic diastolic (congestive) heart failure.
I50.33	Acute on chronic diastolic (congestive) heart failure.
I50.40	Unspecified combined systolic and diastolic heart failure.

1–10 of 29

1/3

Other HCPCS/Device CodesHCPCS

5A0221D

Assistance with Cardiac Output using Impeller pump, Continuous

Provider Actions & Requirements

Prior Authorization

Coverage limited to three life‑threatening indications

Coverage for percutaneous ventricular assist device (pVAD) insertion is limited to three life‑threatening clinical situations and only when intra‑aortic balloon pump (IABP) is not expected to be sufficient. Requests outside these indications will not be considered reasonable and necessary until stronger evidence supports broader use.

Cardiogenic shock
Severe decompensated heart failure with threatening multi‑organ failure
Complications or disturbances of the circulatory system intra‑operatively or postoperatively

Documentation Required

Clinical indication and FDA guideline adherence

Prior authorization and documentation must demonstrate the patient meets one of the three life‑threatening indications and that FDA approval guidelines are adhered to. The documentation should also show that IABP (intra‑aortic balloon pump) is expected to be inadequate or insufficient before proceeding with pVAD.

Provider must retain or have access to supporting clinical documentation upon request.
Benefit coverage is subject to the member's specific plan document and applicable laws.
For Medicare Advantage members, follow delegate prior authorization requirements where applicable.

Denial Risk

IABP expected first‑line when sufficient

Before pVAD insertion, less invasive mechanical circulatory support with an IABP is expected to be used when it is clinically sufficient. pVAD should be considered only when IABP is not expected to provide adequate hemodynamic support.

Documentation must state why IABP is inadequate or insufficient for the individual patient.

Billing Rule

Documentation and benefit determination

Providers are expected to retain or have access to all documentation and coding necessary to support coverage determinations and claims submission. The Medicare Advantage policy guidance and code references (e.g., CPT 33990, 33991, 33995) are provided for informational purposes and do not guarantee payment.

Affected CPT codes: 33990, 33991, 33995 — include clinical rationale in the record.
Benefit coverage determined by member-specific plan document; in case of conflict, the plan document supersedes this policy.
For delegate-managed MA plans, follow the delegate's utilization management requirements.

Background

Percutaneous ventricular assist devices (pVAD) such as Impella and TandemHeart are endovascular cardiac assist devices inserted percutaneously to provide temporary mechanical circulatory support. They are used for short‑term support in severe, life‑threatening scenarios—specifically cardiogenic shock, severe decompensated heart failure with threatening multi‑organ failure, or intraoperative/postoperative circulatory complications—and only when less invasive support (eg, IABP) is not expected to be sufficient. Clinical evidence shows pVADs provide superior hemodynamic support compared with IABP (higher cardiac index and mean arterial pressure, lower pulmonary capillary wedge pressure), but trials have not demonstrated a clear mortality benefit at 30 days and report higher rates of some complications (notably increased bleeding with TandemHeart). Device placement must follow applicable FDA guidance and local coverage determinations.

Definitions

Percutaneous Ventricular Assist Device (pVAD)

DefinitionAn endovascular cardiac assist device inserted percutaneously to provide temporary mechanical circulatory support.

ExamplesImpella; TandemHeart.

PurposeProvide short-term circulatory support in patients with severe cardiac compromise (eg, to support cardiac output and hemodynamics).

Life‑threatening situations (policy)

Cardiogenic shockCovered life‑threatening indication per policy.

Severe decompensated heart failureSevere decompensated heart failure with threatening multi‑organ failure.

Intraoperative/postoperative circulatory complicationsComplications or disturbances of the circulatory system occurring intra‑operatively or postoperatively where IABP is not expected to be sufficient.

Temporary MCS

DefinitionTemporary mechanical circulatory support (MCS) intended for short‑term use as a bridge to recovery or decision in patients with hemodynamic compromise or shock.

RoleUsed to stabilize patients who fail to respond to initial interventions and to allow optimization of end‑organ function prior to weaning, durable MCS, or transplant evaluation.

Modalities includedPercutaneous and extracorporeal ventricular assist devices are examples of temporary MCS.

Prophylactic hemodynamic support for high-risk PCI

DefinitionElective insertion of an appropriate hemodynamic support device as an adjunct to PCI to prevent hemodynamic compromise during high‑risk percutaneous coronary intervention (HRPCI).

Recommendation strengthACC/AHA/SCAI guideline: may be reasonable in selected high‑risk patients (Strength of recommendation: 2B).

Intended useProphylactic support is preventive and elective — used to maintain stability during complex or high‑risk coronary revascularization procedures.