CurrentMass General Brigham Health PlanPolicy N/A

Leadless Cardiac Pacemakers — Coverage Criteria

Medical necessity guidelines for FDA‑approved single‑chamber right ventricular leadless cardiac pacemakers used in place of transvenous pacemakers; governs coverage determinations for Mass General Brigham Health Plan members across commercial, Medicare Advantage, One Care, and SCO lines where specified.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLeadless Cardiac Pacemakers — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Commercial, Medicare Advantage, One Care, and SCO plans and verify plan-specific authorization and payable status for ACO and MassHealth members.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered device type

33274Procedure code (info)

Jan 2026Effective

Not payableMassHealth

NCD/ArticleCMS guidance

Coverage Criteria

Initial Therapy Criteria

Covered when ALL of the following are met:

Device specification: Device must be an FDA-approved single-chamber right ventricular leadless cardiac pacemaker (eg Medtronic Micra VR or Abbott Aveir VR)

This policy does not cover leadless cardiac pacemakers that are not FDA‑approved. Also excluded are use of leadless pacemakers for any indications other than those specifically listed as medically necessary in this policy. Additional device–related exclusions include cases where an inferior vena cava filter is in place or the patient has a mechanical tricuspid valve.

Use of dual chamber, left ventricular, or atrial leadless cardiac pacemakers is considered not medically necessary and is not covered for any indications under this policy.

Coding

Listed procedure code (informational)CPT

33274

Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular, including imaging guidance (eg, fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (eg, interrogation or programming), when performed

Policy Summary

PayerMass General Brigham Health Plan

PolicyLeadless Cardiac Pacemakers — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for Commercial, Medicare Advantage, One Care, and SCO plans and verify plan-specific authorization and payable status for ACO and MassHealth members.

SourceLink

On This Page

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Provider Actions and Billing Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Commercial, Medicare Advantage, One Care, and Senior Care Options (SCO) members. Providers must obtain prior authorization before scheduling leadless cardiac pacemaker implantation for affected lines of business.

Prior authorization required: Commercial, Medicare Advantage, One Care, SCO
Mass General Brigham ACO: prior authorization not required but note: Mass General Brigham ACO = not payable (see denial risk)

Documentation Required

Required Documentation and Coding

Submit the clinical documentation that demonstrates the member meets medical necessity criteria for an FDA‑approved single‑chamber right ventricular leadless pacemaker (e.g., Medtronic Micra VR or Abbott Aveir VR). Include device model, indication, and supporting diagnostic information (ECG, rhythm strips, prior device infection history, venous access imaging) with the authorization request and claim.

Document device model and manufacturer (e.g., Micra VR, Aveir VR)
Include indication: symptomatic bradycardia (high‑grade AV block, sinus node dysfunction) or bradycardia‑tachycardia syndrome
Provide evidence of contraindication to transvenous leads (history of CIED infection, venous occlusion/anomaly, planned/active hemodialysis AV fistula, bioprosthetic tricuspid valve)
Attach relevant imaging and procedural documentation (venous ultrasound, fluoroscopy reports)

Billing Rule

Billing / Coding Guidance

Use CPT 33274 for transcatheter insertion or replacement of a permanent leadless pacemaker (includes imaging guidance and device evaluation). Listing a code is informational and does not guarantee coverage — confirm prior authorization and medical necessity before billing.

CPT: 33274 — Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular (includes imaging guidance and device evaluation)
Inclusion of code is informational only; verify coverage and authorization status prior to claim submission

Denial Risk

Denial / Payability Risk

Mass General Brigham ACO members are not payable for leadless pacemaker placement — claims may be denied. Confirm member’s line of business and payer coverage before proceeding; for Medicare Advantage members follow CMS NCD/LCD guidance (NCD 20.8.4 and Article A59819) when determining medical necessity.

Not payable / denial risk: Mass General Brigham ACO
Follow CMS guidance for Medicare Advantage determinations when applicable (NCD 20.8.4; Article A59819)

Definitions

Leadless cardiac pacemaker — definition and key characteristics

Device typeFDA‑approved single‑chamber right ventricular (RV) leadless cardiac pacemaker (examples: Medtronic Micra VR, Abbott Aveir VR)

Design characteristicsTranscatheter, generator‑less pacing system implanted in the right ventricle that eliminates a subcutaneous generator pocket and transvenous leads

Indicated chamber/supportSingle‑chamber right ventricular pacing only (policy applies to single‑chamber RV devices)

Implant approachPercutaneous transcatheter implantation into the right ventricle

Coverage scopeConsidered medically necessary when all policy clinical criteria are met (see coverage criteria) for eligible members

Symptomatic bradycardia — definition and common causes

DefinitionBradycardia that produces symptoms (eg, syncope, presyncope, dizziness, fatigue) attributable to slow heart rate or pauses

Common causes listed in policyHigh‑grade atrioventricular (AV) block (paroxysmal or permanent); bradycardia‑tachycardia syndrome; sinus node dysfunction (sinus bradycardia or sinus pauses)

Relation to device indicationPresence of symptomatic bradycardia from the above causes is one of the required indications for consideration of a single‑chamber RV leadless pacemaker

OpenPayer

Leadless Cardiac Pacemakers — Coverage Criteria

Coverage Criteria

Coding

Provider Actions and Billing Requirements

Background

Definitions