Premera Bluecross Leadless Pacemakers Prior Auth

inv-01: Micra single-chamber transcatheter pacing system — medically necessary criteria

Covered when ALL of the following are met.

Micra single-chamber coverage: The Micra single-chamber transcatheter pacing system may be considered medically necessary when BOTH of the following conditions are met:

Qualifying rhythm conditions: The individual has ONE of the following: symptomatic paroxysmal arteriovenous (AV) block; permanent high-grade AV block; symptomatic bradycardia‑tachycardia syndrome; or sinus node dysfunction (sinus bradycardia or sinus pauses).

Contraindication to conventional leads: The individual has a significant contraindication precluding placement of conventional single‑chamber ventricular pacemaker leads such as ANY of the following: history of an endovascular or cardiovascular implantable electronic device (CIED) infection or is at high risk for infection; limited access for transvenous pacing (venous anomaly, occlusion of axillary veins, planned use of such veins for a semi‑permanent catheter, or current/planned use of an arteriovenous fistula for hemodialysis); or presence of a bioprosthetic tricuspid valve.

inv-02: Investigational devices / indications — 2 top-level nodes

Micra investigational: The Micra single‑chamber transcatheter pacing system is considered investigational in all other situations in which the above medically necessary criteria are not met.

Aveir investigational: The Aveir single‑chamber transcatheter pacing system is considered investigational for all indications; the Aveir DR dual‑chamber pacing system is considered investigational.

inv-03: Coverage groups by clinical eligibility and device type

Coverage considerations reference the following clinical groups and evidence findings.

Group A: Medically eligible for conventional pacemaker: Individuals with a guideline-based ventricular pacing indication who are medically eligible for a conventional transvenous pacemaker: evidence for Micra shows high procedural success (>99%) and device effectiveness, with lower overall 6‑month complication rates in adjusted analyses compared with transvenous devices but with specific implantation risks (e.g., pericardial effusion/perforation); overall evidence is insufficient to demonstrate improved net health outcomes versus conventional pacemakers.evidence-based summary

See Micra pivotal and postapproval study summaries.

Group B: Medically ineligible for conventional pacemaker: Individuals with a guideline-based ventricular pacing indication who are medically ineligible for a conventional pacing system: subgroup and postapproval data for Micra show successful implantation in ~98%–99% of cases with similar short‑term safety; although long‑term data are limited, short‑term benefits may outweigh risks for those ineligible for conventional systems.evidence-based summary

See subgroup analyses and postapproval data.

inv-04: Clinically supported coverage subgroup — Covered when ALL of the following are met (per clinical input summaries):

Covered when ALL of the following are met (per clinical input summaries):

Primary conditions: Patient has a guideline‑based indication for a ventricular pacing system (significant bradycardia/high‑grade AV block or symptomatic sinus node dysfunction).

Based on clinical input.

Patient rhythm contexts: Either: (a) normal sinus rhythm with rare episodes of AV block or sinus arrest with severe physical disability or short expected lifespan; OR (b) chronic atrial fibrillation.

From 2023 clinical input.

Contraindication to transvenous pacing: History of an endovascular or CIED infection or high infection risk; limited transvenous access (venous anomaly or axillary vein occlusion, planned/current use of vein for semi‑permanent catheter or AV fistula for hemodialysis); or presence of a bioprosthetic tricuspid valve.

From 2019 and 2023 clinical input.

inv-05: Use when conventional pacing is an option — Considered reasonable but with mixed support:

Considered reasonable but with mixed support:

Medically eligible patients: For patients who are medically eligible for conventional transvenous pacemaker systems, use of Micra or Aveir devices is considered consistent with practice but clinical input reports mixed support that this use provides a clinically meaningful improvement in net health outcomes; additional justification is required when conventional systems are an option.

From 2023 clinical input.

inv-06: Summary of policy stance from history — 1 top-level node

policy history and investigational statements: History notes that the Micra TPS may be considered medically necessary in patients who are not eligible for conventional pacemakers when specified conditions are met; prior updates added investigational statements designating the Aveir TPS and dual‑chamber leadless pacemakers as investigational.

See policy history entries.

Contraindications to the use of leadless transcatheter pacemakers include: high sinus rates requiring atrial tracking; weak atrial contraction; symptoms during loss of atrioventricular (AV) synchrony; and frequent premature atrial or ventricular contractions. These clinical features may impair device sensing or the maintenance of AV synchrony and are specifically listed in the policy as exclusionary conditions for leadless pacing candidacy.

The evidence is insufficient to conclude that leadless pacing systems (single- or dual-chamber) produce improved net health outcomes broadly compared with conventional transvenous pacemakers. Uncertainties include device durability and end-of-life management, limited data on device-device interactions when multiple devices are present, and restricted retrieval experience for some systems. For dual‑chamber leadless systems, early study results do not yet demonstrate clear net health benefit versus standard approaches.

NICE guidance (2018) concludes that evidence on efficacy for leadless cardiac pacemaker implantation is inadequate in quantity and quality and that there are serious but recognized complications. It recommends that: leadless pacemakers for people who can undergo conventional pacemaker implantation should only be used in the context of research; and for people in whom conventional implantation is contraindicated, leadless devices should be used only with arrangements for clinical governance, consent and audit or research.

This medical policy does not apply to Medicare Advantage. Member benefits and coverage conditions vary by contract; providers and members should consult the member benefit booklet or contact a member service representative to determine whether benefit limitations apply to a specific service or supply.

Use of Micra or other leadless pacemakers outside the listed qualifying rhythm conditions or in the absence of a significant contraindication to conventional single‑chamber ventricular pacemaker leads is considered investigational and not medically necessary. The policy requires that individuals have a qualifying rhythm (for example symptomatic paroxysmal or permanent high‑grade AV block, symptomatic bradycardia‑tachycardia syndrome, or sinus node dysfunction) and a documented contraindication to conventional transvenous single‑chamber ventricular leads to meet coverage criteria.

For individuals who are medically eligible for conventional transvenous pacing systems, the available evidence does not demonstrate that routine use of single‑chamber leadless pacing systems improves net health outcomes compared with conventional pacemakers. Therefore, broad or routine use in medically eligible patients is not supported by the policy and would generally be considered not medically necessary without additional justification.

NICE specifically recommends that when conventional pacemaker implantation is possible, leadless pacemakers should only be used in the context of research. The policy aligns with this view by restricting coverage of leadless systems to situations where qualifying rhythm indications are present and conventional transvenous leads are contraindicated, or by treating use outside those conditions as investigational.

Per the policy history and recent updates, dual‑chamber leadless pacemakers and the Aveir transcatheter pacing system have been designated investigational. The policy cites limited and early evidence for dual‑chamber leadless systems (pivotal single‑cohort results with ~90% freedom from complications at 3–6 months) but concludes that evidence is insufficient to determine improved net health outcomes; accordingly these devices are treated as investigational in the policy history and statements.

Coding and Procedure Codes

CPT codes (partial list)CPT

33274	Transcatheter insertion or replacement of permanent leadless pacemaker, right ventricular; including imaging guidance fluoroscopy, venous ultrasound, ventriculography, femoral venography) and device evaluation (e.g- interrogation or programming), when performed
0795T	Transcatheter insertion of permanent dual-chamber leadless pacemaker; including imaging guidance fluoroscopy, venous ultrasound, right atrial angiography, right ventriculography, femoral venography) and device evaluation (interrogation or programming), when performed; complete system (i.e, right atrial and right ventricular pacemaker components)

CPT codes (continued)CPT

0796T	Transcatheter insertion of permanent dual-chamber leadless pacemaker; including imaging guidance fluoroscopy, venous ultrasound, right atrial angiography, right ventriculography, femoral venography) and device evaluation (e.g, interrogation or programming), when performed; right atrial pacemaker component (when an existing right ventricular single leadless pacemaker exists to create a dual-chamber leadless pacemaker system)
0797T	Transcatheter insertion of permanent dual-chamber leadless pacemaker; including imaging guidance and device evaluation, when performed; right ventricular pacemaker component (when part of a dual-chamber leadless pacemaker system)
0801T	Transcatheter removal and replacement of permanent dual-chamber leadless pacemaker; including imaging guidance and device evaluation, when performed; dual-chamber system (right atrial and right ventricular pacemaker components)
0802T	Transcatheter removal and replacement of permanent dual-chamber leadless pacemaker; including imaging guidance and device evaluation, when performed; right atrial pacemaker component
0803T	Transcatheter removal and replacement of permanent dual-chamber leadless pacemaker; including imaging guidance and device evaluation, when performed; right ventricular pacemaker component (when part of a dual-chamber leadless pacemaker system)
0823T	Transcatheter insertion of permanent single-chamber leadless pacemaker; right atrial, including imaging guidance

CPT/HCPCS codes (removal/replacement and HCPCS)mixed

0824T	Transcatheter removal of permanent single-chamber leadless pacemaker, right atrial, including imaging guidance fluoroscopy, venous ultrasound, right atrial angiography and/or right ventriculography, femoral venography, cavography), when performed
0825T	Transcatheter removal and replacement of permanent single-chamber leadless pacemaker; right atrial, including imaging guidance and device evaluation (e.g, interrogation or programming) when performed
C1605	Pacemaker; leadless, dual chamber (right atrial and right ventricular implantable components), rate-responsive; including all necessary components for implantation
C1740	Leadless electrode, transmitter; battery (all implantable); for sequential left ventricular pacing (new code effective 10/01/25)

CED / CMS-approved study identifiersmixed

NCT04559945	The LEADLESS II IDE Study (trial identifier) - listed among CMS-approved studies
NCT03039712	Micra CED Study (trial identifier) - CMS-approved
NCT04235491	Micra AV CED (trial identifier) - CMS-approved
NCT04798768	MODULAR ATP (trial identifier) - CMS-approved
NCT05336877	Aveir VR CED (trial identifier) - CMS-approved
NCT05932602	Aveir DR CED (trial identifier) - CMS-approved
NCT06100770	Aveir AR CED (ARRIVE) (trial identifier) - CMS-approved
NCT02536118	Micra Post-Approval Registry (trial identifier) - CMS-approved

Coding updates and listed codesmixed

0795T	CPT code previously added (document notes addition effective 7/1/2023)
0803T	CPT code previously added (document notes addition effective 7/1/2023)
0823T	CPT code added 01/01/24 (coding update)
0824T	CPT code added 01/01/24 (coding update)
0825T	CPT code added 01/01/24 (coding update)
0826T	CPT code removed 08/01/24
C1605	HCPCS code added effective 7/1/2024
C1740	HCPCS code noted as coding update to be added 10/01/25 (history)

AV synchrony (study thresholds)

Study thresholds for AV synchrony>70% resting AV synchrony (primary study threshold)

Alternate synchrony metric≥85% of total cardiac cycles synchronous (used in some Micra AV analyses)

Signal used to assess AV synchronyAtrial mechanical contraction (A4 signal) amplitude measured by Micra AV

Prior Authorization, Documentation, and Workflow

Prior Authorization

Prior Authorization Required and Evidence for Review

Prior authorization is required for leadless transcatheter pacemaker placement. Requests must include documentation that the individual meets the device indication for ventricular pacing AND has a significant contraindication to placement of a conventional transvenous single‑chamber ventricular pacemaker.

Prior authorization must document both: (1) a qualifying rhythm indication (e.g., symptomatic paroxysmal or permanent high‑grade AV block, symptomatic bradycardia‑tachycardia syndrome, or sinus node dysfunction) and (2) a significant contraindication to conventional single‑chamber transvenous ventricular pacemaker leads (e.g., prior CIED infection or high infection risk; limited transvenous access due to venous anomaly or occlusion or planned use of veins for dialysis/semipermanent catheters; presence of a bioprosthetic tricuspid valve).
If documentation does not clearly show both the device indication and the contraindication to conventional pacing, the request may be denied.
Include relevant clinical records, diagnostic test results, prior procedure notes, and reason for unsuitability of conventional pacemaker leads.

Prior Authorization

Medicare CED / Study‑Based Prior Authorization

When seeking Medicare coverage, procedures must comply with CMS Coverage with Evidence Development (CED) requirements. For Medicare members, the procedure must be performed within a CMS‑approved prospective longitudinal study or an FDA post‑approval study approved by CMS.

Medicare CED applies only to Traditional Medicare — Medicare Advantage plans are not governed by this CED policy within this document; confirm applicability with member plan.
List of currently CMS‑approved studies (examples listed in policy): Micra CED studies, Micra AV CED, Aveir CED studies, and other CMS‑approved prospective studies (see policy Table/registry references).
If seeking Medicare reimbursement, include documentation of enrollment/participation in the named CMS‑approved study and the study protocol identifier (NCT number) with the authorization request.

Billing Rule

Coding and Benefit Verification

Verify member benefits and apply current coding when submitting authorization and claims. Ensure coding reflects current CPT/HCPCS updates and that members are informed about potential cost share.

Confirm member coverage and plan limits with the member benefit booklet or member services; this policy does not apply to Medicare Advantage.
Include applicable codes on the authorization request and claim. Recent coding updates: addition of CPT codes 0795T–0803T (added 7/1/2023), 0823T–0825T (added 1/1/2024); CPT 0826T removed (08/01/24). New HCPCS code C1605 effective 7/1/2024; future HCPCS additions may occur (e.g., C1740 noted for 10/01/25).
Providers should anticipate member cost share according to the specific benefit plan and document any prior discussions with the member about potential financial liability.

Note

Therapy and Clinical Sequencing Considerations

Clinical sequencing: leadless single‑chamber pacemakers are intended primarily for individuals who are medically ineligible for conventional transvenous single‑chamber ventricular pacemakers. Therapy sequencing considerations should be documented to show why conventional alternatives are not suitable.

Document why a conventional transvenous pacemaker is not an option (e.g., infection risk, venous access limitations, planned dialysis access, or presence of bioprosthetic tricuspid valve).
Consider and document discussion of alternative therapies (conventional transvenous single‑ or dual‑chamber pacemaker, epicardial leads, transiliac approaches) and why these were not appropriate or feasible.
Clinical input supports use of leadless systems primarily for patients medically ineligible for conventional systems; if the patient is medically eligible for conventional pacing, justify reasons for choosing leadless therapy and expect mixed support from clinical reviewers.

Documentation Required

Required Clinical Documentation and Evidence for Review

Required clinical documentation and evidence to support medical necessity should be submitted with the prior authorization request. Lack of required documentation may result in denial.

Required documentation: detailed history and physical, ECGs, rhythm monitoring reports, procedure notes, imaging or venography demonstrating venous occlusion or anomaly (if claimed), documentation of prior CIED infection or high infection risk, and records regarding dialysis access planning.
Required evidence for review: summaries of pivotal and post‑approval study outcomes (e.g., Micra pivotal and postapproval data, Medicare registry findings), and documentation that the individual is medically ineligible for a conventional pacing system when that is the basis for coverage.
If requesting Medicare coverage under CED, include explicit documentation of enrollment in the applicable FDA post‑approval study or CMS‑approved CED study and provide the NCT identifier and enrollment confirmation.
Operational note: include device model and intended implant type (e.g., Micra single‑chamber, Micra AV, Aveir) and any device‑specific considerations (e.g., AV synchrony goals, anticipated retrieval concerns).

Definitions and Device Names

VDD pacing definition

DefinitionVDD pacing: sensing in both atrium and ventricle with pacing only in the ventricle; mode supports inhibited and triggered operation

Clinical useUsed to maintain AV synchrony, e.g., to address pacemaker syndrome when atrial-ventricular coordination is reduced

Device exampleMicra AV supports VDD pacing as a leadless implementation

AV synchrony definition

DefinitionAV synchrony: coordinated atrial and ventricular contractions achieved by sensing atrial activity and pacing the ventricle accordingly

Clinical importanceMay reduce morbidity and pacemaker syndrome compared with ventricular-only stimulation

Micra AV mechanismRelies on sensing atrial mechanical signals (A4) to achieve AV synchronous ventricular pacing; synchrony varies by individual

Leadless pacemaker definition

DefinitionLeadless pacemaker: a self-contained, capsule-sized pacing device implanted via femoral venous access that eliminates transvenous leads and a chest pocket

ComponentsContains battery, electronics, and fixation mechanism (e.g., Micra tines or Aveir screw-in helix)

Clinical implicationsAvoids lead- and pocket-related complications but has limited lifespan and retrieval/replacement challenges

Conventional pacemaker definition

DefinitionConventional (transvenous) pacemaker: a system with a subcutaneously implanted generator and transvenous leads placed within the heart (single- or dual-chamber)

Typical configurationGenerator implanted in the infraclavicular region with leads to the right atrium and/or right ventricle

Clinical considerationsAssociated with lead- and pocket-related complications; some patients are medically ineligible due to venous access or infection risk

Atrioventricular synchrony (AVS) for Micra AV

DefinitionAtrioventricular synchrony (AVS) for Micra AV: maintenance of AV synchrony by sensing atrial mechanical contraction (A4 signal) to trigger synchronous ventricular pacing

Assessment metrics>70% resting AV synchrony or ≥85% synchronous cardiac cycles cited in Micra AV study analyses

LimitationsAVS achieved by Micra AV varies between individuals and can be affected by mechanical vibration and patient-specific factors

Micra — device name reference

Device nameMicra transcatheter pacing system (Micra TPS)

Form factorCapsule-sized leadless pacemaker (~25.9 mm length for Micra) implanted via a 23 French femoral delivery catheter

Regulatory noteFDA PMA approval for Micra (P150033) and PMA supplement for Micra AV (S061) enabling AV synchronous pacing

Aveir — device name reference

Device nameAveir leadless pacing system (Aveir VR/DR)

Form factor and fixationLarger capsule than Micra (Aveir VR ~42 mm) delivered via a 25 French catheter; uses a screw-in helix fixation

Regulatory noteAveir DR received PMA supplement approval for dual-chamber pacing (P150035, June 2023)

Aveir TPS — referenced as investigational in history and associated studies

Regulatory/Policy stanceAveir TPS referenced as investigational in prior policy history and associated with post-approval/CED studies

Device contextIncludes Aveir single- and dual-chamber leadless pacing systems; prior Nanostim issues (migration, battery) addressed in Aveir design

Study linkageAveir-related CED and post-approval study identifiers are listed in the policy evidence sections

Micra TPS — multiple cited studies and registry data referenced

Policy referencesMicra TPS is cited throughout with pivotal trials, post-approval registry data, and multiple studies informing coverage decisions

Regulatory statusMicra PMA approved (P150033) with subsequent PMA supplement for Micra AV (S061) enabling AV synchronous pacing

Evidence basisMultiple studies and registries (pivotal, post-approval) report high procedural success (>99%) and AV synchrony outcomes used in policy analyses

OpenPayer

Leadless Cardiac Pacemakers

Coverage and Medical Necessity Criteria

Coding and Procedure Codes

Prior Authorization, Documentation, and Workflow

Clinical Background and Evidence Summary

Definitions and Device Names