Leadless Cardiac Pacemakers — Coverage Criteria
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This policy governs medical necessity coverage for single- and dual‑chamber leadless transcatheter cardiac pacemakers for BCBS North Carolina members and describes when these devices are considered covered, investigational, and applicable billing codes.
Added statement to Not Covered section: 'The Aveir™ DR dual-chamber pacing system is considered investigational for all indications.'
Added multiple temporary HCPCS/T codes (0795T–0804T and 0823T–0826T) to the Billing/Coding section at various dates.
Policy Guidelines and References updated and clarified wording in When Covered and Not Covered sections across 2023–2025 updates.
Coverage Criteria for Leadless Transcatheter Cardiac Pacemakers
inv-01: Covered: Single‑chamber (RV) leadless pacemaker — initial coverage criteria
Single chamber (right ventricular) transcatheter pacing systems are considered medically necessary when BOTH conditions below are met:
Examples listed in policy
inv-02: Investigational / Not covered
Not covered / investigational statements
Added statement in policy updates that specific dual-chamber devices (eg, Aveir DR) are investigational for all indications.
Right atrial single‑chamber transcatheter pacing systems and dual‑chamber transcatheter pacing systems are considered investigational for all indications. These systems lack sufficient evidence demonstrating a net health benefit compared with conventional transvenous pacemakers, and therefore are not covered under the policy for any indication.
Single‑chamber (right ventricular) transcatheter pacing systems are considered investigational in all situations in which the specific coverage criteria are not met. If the member does not meet the policy’s defined criteria for medical necessity for a single‑chamber (RV) leadless pacemaker, placement of a single‑chamber transcatheter pacing system is not covered.
The Aveir™ DR dual‑chamber pacing system is explicitly considered investigational for all indications and therefore not covered. This statement was added to the Not Covered section in the 7/1/24 policy update and reflects the policy position that dual‑chamber leadless systems (including Aveir™ DR) lack sufficient evidence to demonstrate improved net health outcomes.
inv-03: Evidence-based coverage conclusions
Policy conclusions summarized from evidence sections
Post-approval study planned through 9 years; insufficient evidence for net health benefit
Evidence is insufficient to determine that dual‑chamber leadless pacing systems (including certain Aveir systems) result in an improvement in net health outcome. Although a pivotal prospective single‑cohort study reported a 12‑month complication‑free rate of 88.6% and met a composite atrial capture performance endpoint in 92.8% of individuals, the overall body of evidence — including long‑term outcomes and populations medically ineligible for conventional systems — is inadequate to establish clinical benefit.
Billing and Coding
Provider Actions and Documentation Requirements
Inclusion of codes does not guarantee reimbursement; records may be requested
Applicable service codes are listed in the Billing/Coding section; inclusion of a code does not guarantee reimbursement. Providers should be aware that BCBSNC may request medical records to determine whether services meet medical necessity criteria.
- Applicable service codes include: 0795T–0804T, 0823T–0826T, and C1605
- Inclusion in the code list is not a guarantee of payment
Listed service codes subject to medical necessity review
The policy lists specific applicable service codes but notes that inclusion does not guarantee reimbursement; BCBSNC may review medical necessity and request supporting medical records to adjudicate claims.
Medical records may be requested — letters alone are insufficient
BCBSNC may request medical records to determine medical necessity; letters of support or explanation alone are not sufficient unless they include all specific information needed for the determination.
- Respond promptly to requests for medical records to avoid delays in claims processing
- Letters of support/explanation are supplemental but not sufficient by themselves unless they contain all required clinical details
Provide complete clinical documentation when records are requested
When BCBSNC requests medical records for a medical necessity review, include all specific clinical information required to adjudicate the request; letters of support should only be relied on if they contain the complete information set.
- Ensure documentation fully addresses the medical necessity criteria listed in the policy (indication and contraindication details)
- Include operative reports, history and physical, diagnostic testing, and prior treatment attempts as applicable
Requested medical records — absence may trigger denial
BCBSNC may request medical records for determination of medical necessity; failure to provide requested documentation may result in denial of coverage.
- Maintain and submit complete medical records when requested to support the claim
- Absence of requested documentation can trigger denial
Services not meeting criteria may be denied; code listing not a guarantee
Services that do not meet the policy's medical necessity criteria may be denied. Inclusion of a code in the Billing/Coding section does not guarantee reimbursement, and BCBSNC may request medical records to determine whether the specific service meets criteria.
- Verify that the patient meets all coverage criteria before billing
- Be prepared to provide supporting records if BCBSNC requests them
Step therapy / additional provider actions
None specified in the policy for step therapy or additional provider prerequisites beyond documentation and medical necessity review; follow standard prior authorization and documentation practices as outlined elsewhere in the policy.
- No step therapy requirements are specified in this policy
- Follow prior authorization guidance and submit complete records when requested
Confirm criteria and be prepared to supply records
Providers should reference the Billing/Coding section for the full list of applicable codes and be prepared to supply medical records if BCBSNC requests them to determine medical necessity.
- Confirm the patient meets the policy's medical necessity criteria prior to submitting claims
- Retain and be ready to submit operative reports, diagnostic tests, and clinical notes supporting the indication
Background
Pacemakers replace or support the heart’s intrinsic pacing to treat symptomatic bradyarrhythmias. Conventional transvenous systems consist of a pulse generator and intravascular leads implanted in a chest pocket, while leadless cardiac pacemakers are self‑contained, capsule‑sized intracardiac devices delivered via femoral venous access that eliminate transvenous leads and a surgical pocket. Leadless systems were developed to avoid lead‑ and pocket‑related complications and are primarily considered for single‑chamber ventricular pacing when policy criteria are met.
Definitions
Revision History and Policy Changes
HCPCS code C1605 was added to the Billing/Coding section effective 7/1/24.
Added statement to Not Covered section that the Aveir™ DR dual-chamber pacing system is considered investigational for all indications.
Policy Guidelines and References updated and device-specific names (eg, 'The Micra', 'The Aveir™', 'The Aveir™ DR') were replaced with broader descriptors (eg, 'Single chamber (right ventricular)' and 'Dual chamber'), revising When Covered and Not Covered statements accordingly.
Description section edited for clarity and Policy Guidelines and References updated following advisory panel and medical director reviews in 6/2026.
Material changes effective 2024‑07‑01: the Not Covered section was updated to add the statement that the Aveir™ DR dual‑chamber pacing system is considered investigational for all indications, and code C1605 was added to the Billing/Coding section. Policy guidelines note post‑approval study follow‑up planned through 9 years. Last formal review date listed is 2023‑12‑29 with next review scheduled for 2026‑06‑01.
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