Leadless Cardiac Pacemakers
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Medical policy governing coverage and clinical criteria for leadless (transcatheter) cardiac pacemakers for Blue Cross Blue Shield of North Carolina members; affects providers requesting coverage and prior authorization for these devices and related procedures.
Updates to When Covered and Not Covered sections in 7/30/25 changed language to refer to 'Single chamber (right ventricular)' and removed brand-specific references such as 'The Micra' and 'The Aveir™'.
Code C1605 was added to the Billing/Coding section effective 7/1/24.
Added numerous temporary CPT/T code additions (0795T–0804T, 0823T–0826T) to the Billing/Coding section across 2023–2024 updates.
Coverage Criteria for Leadless Cardiac Pacemakers
Eligibility for covered single‑chamber leadless pacemaker
Covered when ALL of the following are met:
ALL of the following
ALL of the following
ONE of
- Symptomatic paroxysmal or permanent high-grade atrioventricular (AV) block
- Symptomatic bradycardia–tachycardia syndrome
- Sinus node dysfunction (sinus bradycardia or sinus pauses)
ALL of the following
ONE of
- History of an endovascular or cardiovascular implantable electronic device (CIED) infection or high risk for infection
- Limited transvenous access for pacing (e.g., venous anomaly, occlusion of axillary veins, planned use of those veins for a semi-permanent catheter, or current/planned use of an arteriovenous fistula for hemodialysis)
- Presence of a bioprosthetic tricuspid valve
Coverage criteria and notes
Policy-level coverage statements, evidence considerations, and operational notes:
ALL of the following
ALL of the following
- Evidence for dual‑chamber leadless pacing is insufficient to determine improvement in net health outcome; a pivotal prospective single‑cohort study reported a 12‑month complication‑free rate of 88.6% (95% CI: 84.5%–91.8%) and met the composite atrial capture performance endpoint in 92.8% of individuals; acute and long‑term events are being captured in a post‑approval study through 9 years.
ALL of the following
- No evidence exclusively enrolling individuals medically ineligible for conventional pacing was identified; evidence is insufficient to determine net health outcome improvement in this subgroup.
ALL of the following
- Other alternatives (epicardial leads, transiliac placement) have limited data: epicardial leads are associated with longer ICU stay, greater blood loss, and longer ventilation times versus conventional systems; transiliac placement case series report atrial lead dislodgement rates of approximately 7%–21%.
ALL of the following
- Policy language was updated (7/1/24 and 7/30/25) to clarify scope: statements were changed to refer to 'Single chamber (right ventricular)' devices and brand‑specific references were removed; the Aveir DR (dual‑chamber) and right atrial single‑chamber transcatheter systems are designated investigational for all indications per the updates.
ALL of the following
- Inclusion of procedure codes in the policy does not guarantee reimbursement; BCBSNC may request medical records and documentation to determine medical necessity.
Billing, CPT/HCPCS and Service Codes
| 0795T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0796T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0797T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0798T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0799T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0800T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0801T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0802T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0803T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
| 0804T | Temporary/procedure codes listed as applicable service codes (added 6/30/23 effective 7/1/23). |
Prior Authorization, Documentation, and Billing Notes
Prior authorization and documentation may be requested; codes do not guarantee reimbursement
BCBSNC may request medical records and other documentation to determine medical necessity; letters of support or explanation alone are not sufficient unless they include all information needed for the determination. Inclusion of a code in the policy’s billing/coding section does not guarantee it will be reimbursed.
- BCBSNC may request medical records for determination of medical necessity; letters of support/explanation are not sufficient unless all specific information is provided.
- Inclusion of a code in the Billing/Coding section does not guarantee reimbursement.
Billing/coding codes listed; be prepared to provide full medical records
Applicable service codes are listed in the policy, but inclusion does not ensure reimbursement. BCBSNC may request medical records to determine medical necessity when these codes are billed.
- Applicable service codes: 0795T, 0796T, 0797T, 0798T, 0799T, 0800T, 0801T, 0802T, 0803T, 0804T, 0823T, 0824T, 0825T, 0826T, C1605.
- When medical records are requested, provide complete documentation; letters of support/explanation are not sufficient unless they include all required information for medical necessity determination.
Definitions and Terminology
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