CurrentIndependent HealthPolicy M20180912076

Impeller Driven Percutaneous Ventricular Assist Devices (Impella)

Medical necessity criteria and coverage stance for use of impeller-driven percutaneous ventricular assist devices (e.g., Impella systems, TandemHeart) for Independent Health members across applicable lines of business.

Policy Summary

PayerIndependent Health

PolicyImpeller Driven Percutaneous Ventricular Assist Devices (Impella)

Policy CodePolicy M20180912076

Change TypeNo material change

Effective DateNov 1, 2018

Next Review Date

Key ActionPre-authorization is not required; apply coverage criteria on retroactive review and ensure required documentation for high-risk PCI adjunct use is included.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Cardiogenic shockPrimary covered indication

High-risk PCISecondary covered indication

Not requiredPrior auth status

Medicare, Commercial, MediSource, Child Health Plus, Essential PlanLines of business

Coverage criteria and clinical indications

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Medically Necessary Indications

Covered when ANY of the following are met:

Covered indications: 1) Acute treatment of cardiogenic shock; OR 2) As an adjunct to percutaneous coronary intervention (PCI) in high-risk patients with unprotected left main or last-remaining-conduit PCI with LVEF < 35%, or with 3-vessel disease and LVEF < 30% provided ALL of the sub-criteria below are met.

Sub-criteria for high-risk PCI adjunct use

NY PCI risk score: Member has been evaluated utilizing the New York State PCI risk scoring system.
Second interventional cardiologist opinion: Documentation of a second interventional cardiologist opinion which states agreement with the appropriateness of the procedure for this patient.
Cardiothoracic surgical opinion: Documentation of a cardiothoracic surgical opinion as to the suitability of the patient for a percutaneous intervention and the acute risk of the percutaneous intervention and stating patient is not a candidate for operative intervention.

This policy does not list any additional exclusion conditions beyond the coverage criteria. Review of the full policy shows only the covered indications and required documentation for high-risk PCI adjunct use; there are no extra exclusion conditions specified in the document.

The document does not explicitly designate any uses of impeller-driven percutaneous ventricular assist devices as not medically necessary. The policy defines medically necessary indications and required documentation for certain uses, but contains no statements labeling specific indications as not medically necessary.

Provider requirements, prior authorization, and documentation

Note

Pre-authorization not required

Pre-authorization not required — criteria will be applied on retroactive review.

Note

Not applicable

Not applicable — No step-therapy sequence specified.

Documentation Required

Required documentation for high-risk PCI adjunct use

Required documentation for high-risk PCI adjunct use — documentation must include evaluation using the New York State PCI risk scoring system, a second interventional cardiologist opinion agreeing with the procedure, and a cardiothoracic surgical opinion stating suitability for percutaneous intervention and that the patient is not a candidate for operative intervention.

Denial Risk

Retro-review risk

Retro-review risk — Services may be subject to retroactive review since pre-authorization is not required; failure to meet documented criteria on retro-review may affect coverage.

Background and device overview

Temporary mechanical circulatory support devices such as Impella and TandemHeart are intended for short-term support to maintain organ perfusion by augmenting cardiac output. They are used in acute settings (for example, the policy covers their use for the acute treatment of cardiogenic shock) and are generally employed short-term (generally <30 days) as part of temporary hemodynamic support.

Definitions

Cardiogenic shock (policy definition)

DefinitionSystemic hypoperfusion with systolic blood pressure <80 mmHg and marked decrease in cardiac index (<1.8 L/min/m2) for ≥30 minutes despite adequate intravascular volume; depressed cardiac index ≤2.2 L/min/m2 and pulmonary-capillary wedge pressure >15 mm Hg.

Clinical contextRepresents severe left ventricular failure requiring temporary mechanical circulatory support such as idpVAD devices.

Impeller driven percutaneous ventricular assist device (idpVAD)

idpVAD descriptionA miniature impeller pump within a catheter that draws blood out of the left ventricle and ejects it into the ascending aorta.

MechanismContinuous-flow axial pump delivered percutaneously across the aortic valve to augment cardiac output and coronary perfusion.

Typical use durationTemporary short-term use (generally <30 days) to maintain organ perfusion.

Percutaneous coronary intervention (PCI)

DefinitionNonsurgical technique for treating obstructive coronary artery disease (also called coronary angioplasty).

IndicationsIncludes treatment for unstable angina, acute myocardial infarction (MI), and multivessel coronary artery disease (CAD).

Role with idpVADidpVAD may be used as adjunctive support during high-risk PCI procedures per policy criteria.